Panobinostat Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant for Patients With Refractory/Relapsed Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Event-Free Survival (EFS) in Participants with Hodgkin's Lymphoma
研究概览
简要总结
The goal of this clinical research study is to learn about the safety and effectiveness of the combination of panobinostat, gemcitabine, busulfan, and melphalan, either with or without rituximab, in patients who have non-Hodgkin's or Hodgkin's lymphoma and are receiving a stem cell transplant.
详细描述
Busulfan Test Dose:
Participant will receive a test dose of busulfan by vein over about 60 minutes. Before and after participant receives this low-level test dose of busulfan, blood will be drawn several times to check how the level of busulfan in participant's blood changes over time. This is called pharmacokinetic (PK) testing. This information will be used to decide the next dose needed to reach the correct blood level that matches participant's body size. Participant will most likely receive this test dose as an outpatient during the week before participant is admitted to the hospital. If it cannot be given as an outpatient, participant will be admitted to the hospital on Day -11 (11 days before participant's stem cells are returned to participant's body) and the test dose will be given on Day -10.
Blood (about 1 teaspoon each time) will be drawn for PK testing about 11 times before participant's test dose of busulfan and 10 times over the 11 hours after the dose. The blood samples will be repeated again on the first day of high-dose busulfan treatment (Day -8). A temporary heparin lock line will be placed in participant's vein to lower the number of needle sticks needed for these draws.
If it is not possible for the PK tests to be performed for any reason, participant will receive the standard fixed dose of busulfan.
Study Drug Administration:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with: DLBCL with one of the following:
- •Primary refractory (no CR to 1st line);
- •High-risk relapse (CR1 <6 months, secondary IPI >1 or high LDH); or,
- •Refractory relapse: No response (SD or PD) to >/= 1 line of salvage.
- •Hodgkin's with one of the following:
- •Primary refractory (no CR to 1st line or PD within 3 months);
- •High-risk relapse (CR1 <1 year, extranodal relapse or B symptoms); or,
- •Refractory relapse: No response (SD or PD) to >/= 1 line of salvage.
- •T-NHL with one of the following:
- •Primary refractory (</= CR to 1st line or relapse within 6 months); or,
- •Nonresponsive (SD/PD) to >/= 1 line of salvage.
- •Adequate renal function, as defined by estimated serum creatinine clearance >/= 50 ml/min and/or serum creatinine </= 1.8 mg/dL
- •Adequate hepatic function (SGOT and/or serum glutamate pyruvate transaminase (SGPT) </= 3 x upper limit of normal (ULN); bilirubin and ALP </= 2 x ULN
- •Adequate pulmonary function with forced expiratory volume at one second (FEV1), forced vital capacity (FVC) and diffusing capacity of lung for carbon monoxide (DLCO) (corrected for Hgb) >/= 50%
- •Adequate cardiac function with left ventricular ejection fraction >/= 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
- •Negative Beta human chorionic gonadotropin (HCG) in woman with child-bearing potential
排除标准
- •Grade >/= 3 non-hematologic toxicity from prior therapy that has not resolved to </= G1
- •Prior whole brain irradiation
- •Corrected QT interval (QTc) longer than 500 ms
- •Active hepatitis B, either active carrier (HBsAg +) or viremic (HBV DNA >/= 10,000 copies/mL, or >/= 2,000 IU/mL)
- •Evidence of either cirrhosis or stage 3-4 liver fibrosis in patients with chronic hepatitis C or positive hepatitis C serology
- •Active infection requiring parenteral antibiotics
- •HIV infection, unless receiving effective antiretroviral therapy with undetectable viral load and normal cluster of differentiation 4 (CD4) counts
- •Radiation therapy in the month prior to enroll
研究组 & 干预措施
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Palifermin (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Panobinostat (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Gemcitabine (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Busulfan (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Melphalan (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Rituximab (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Dexamethasone (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Caphosol (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Glutamine (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Oral Cryotherapy (ice chips) (Other)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Pyridoxine (Drug)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Stem Cell Infusion (Biological)
Cohort A: Diffuse Large B-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: G-CSF (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Palifermin (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Panobinostat (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Gemcitabine (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Busulfan (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Melphalan (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Rituximab (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Dexamethasone (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Caphosol (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Glutamine (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Oral Cryotherapy (ice chips) (Other)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Pyridoxine (Drug)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Stem Cell Infusion (Biological)
Cohort B: Hodgkin's Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: G-CSF (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Palifermin (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Panobinostat (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Gemcitabine (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Busulfan (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Melphalan (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Rituximab (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Dexamethasone (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Caphosol (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Glutamine (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Oral Cryotherapy (ice chips) (Other)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Pyridoxine (Drug)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: Stem Cell Infusion (Biological)
Cohort C: T-Cell Lymphoma
Palifermin on Days -13 to -11 and on Days 0, +1, and +2.
Panobinostat daily from Day -9 to -2.
Gemcitabine administered on Days -8 and -3.
Busulfan test dose administered on day -10. Doses of Days -6 and -5 subsequently adjusted to target an AUC of 4,000 microMol.min-1. Busulfan adjusted to target a cumulative AUC of 16000 and may be significantly higher or lower than 4000 on the last 2 days depending on first PK.
Melphalan on Days -3 and -2.
Rituximab on Day -9 for participants with CD20+ tumors.
Dexamethasone twice a day from Day -8 AM to Day -2 PM.
Caphosol oral rinses 30 mL four times a day used from Day -8.
Oral glutamine, 15 g four times a day, swished, gargled and swallowed started on Day -8.
Pyridoxine three times a day from Day -1.
Stem cells administered by vein on Day 0.
G-CSF 1 time each day starting on Day +5 until blood cell levels return to normal.
干预措施: G-CSF (Drug)
结局指标
主要结局
Event-Free Survival (EFS) in Participants with Hodgkin's Lymphoma
时间窗: 2 years
EFS estimated by using the method of Kaplan and Meier.
Event-Free Survival (EFS) in Participants with Diffuse Large B-Cell Lymphoma
时间窗: 2 years
EFS estimated by using the method of Kaplan and Meier.
Event-Free Survival (EFS) in Participants with T-Cell Lymphoma
时间窗: 2 years
EFS estimated by using the method of Kaplan and Meier.
次要结局
- Treatment-Related Mortality (TRM)(100 days)
- Overall Survival (OS)(100 days)