A Randomized Double-Blinded Placebo Controlled Phase II Study of the Anti-CD30 Antibody, SGN-30 (NSC #731636), in Combination With Gemcitabine, Vinorelbine, and Pegylated Liposomal Doxorubicin (GVD) for Patients With Relapsed/Refractory Hodgkin Lymphoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Number of Participants With Overall Response (OR)
研究概览
简要总结
This randomized phase II trial studies the side effects and how well giving monoclonal antibody SGN-30 together with combination chemotherapy works in treating patients with Hodgkin lymphoma that has returned after a period of improvement or did not respond to previous treatment. Monoclonal antibodies, such as SGN-30, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as gemcitabine hydrochloride, vinorelbine tartrate, and pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving monoclonal antibody SGN-30 together with combination chemotherapy may kill more cancer cells and shrink tumors.
详细描述
PRIMARY OBJECTIVES:
I. To determine the complete and partial response rates following treatment with the anti-cluster of differentiation (CD) 30 antibody, SGN-30 (monoclonal antibody SGN-30), and gemcitabine (gemcitabine hydrochloride), vinorelbine (vinorelbine tartrate), and pegylated liposomal doxorubicin (pegylated liposomal doxorubicin hydrochloride) (GVD) in patients with relapsed or refractory Hodgkin lymphoma (HL).
II. To assess time to progression and overall survival in patients treated with SGN-30 and GVD in patients with relapsed or refractory Hodgkin lymphoma (HL).
III. To evaluate the toxicity of SGN-30 in combination with GVD in patients with relapsed and refractory HL.
SECONDARY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically documented CD30-positive classical Hodgkin lymphoma according to the World Health Organization (WHO) classification of lymphoid malignancies that is recurrent or refractory after at least one prior therapy
- •Note: Patients with nodular lymphocyte predominant HL are not eligible; all other subtypes including nodular sclerosis, lymphocyte-depleted, lymphocyte rich, and mixed cellularity HL may be enrolled
- •Core needle biopsies are acceptable if they contain adequate tissue for primary diagnosis and immunophenotyping; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable; if the original diagnostic specimen is not available, specimens obtained at relapse may be submitted; if multiple specimens are available, please submit the most recent; failure to submit pathology specimens within 60 days of patient registration will be considered a major protocol violation
- •Patients must have relapsed or refractory disease after at least one prior therapy, with at least a 3 week interval from the completion of the most recent chemotherapy or radiotherapy regimen; recovery to =< grade 1 from all toxicities related to the prior treatments is required; patients who have previously received a stem cell transplant are permitted to enroll on this study
- •Prior treatment with an anti-CD30 antibody, gemcitabine, vinorelbine, or pegylated liposomal doxorubicin is not permitted
- •No uncontrolled angina, no myocardial infarction (MI) within 6 months of study entry, and no New York Heart Association (NYHA) class II or greater congestive heart failure (CHF)
- •Baseline left ventricular ejection fraction (LVEF) by multi gated acquisition scan (MUGA) or echocardiogram (ECHO) must be >= 45%
- •Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Measurable disease must be present on either physical examination or imaging studies; evaluable or non-measurable disease alone is not acceptable
- •Measurable disease is defined as any lesion that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 10 mm
- •Non-measurable disease includes all other lesions, including small lesions (< 10 mm) and truly non-measurable lesions
- •Lesions that are considered non-measurable include the following:
- •Bone lesions (lesions, if present, should be noted)
- •Bone marrow involvement (if present, this should be noted)
- •Pleural/pericardial effusion
- •Lymphangitis cutis/pulmonis
- •Pregnant or nursing women may not be enrolled; women of childbearing potential must have a negative serum or urine pregnancy test prior to registration; women and men of reproductive potential should agree to use an effective means of birth control
- •Corrected diffusion capacity of carbon monoxide (DLCO) >= 50%
- •Absolute neutrophil count (ANC) >= 1,200/uL
- •Platelet count >= 100,000/uL
- •Creatinine =< 2.0 mg/dL
- •Bilirubin =< 2.0 mg/dL
- •Absent a history of Gilbert's disease
- •Aspartate aminotransferase (AST) =< 2.0 x upper limits of normal
排除标准
- 未提供
研究组 & 干预措施
Arm II (placebo, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
Arm I (SGN-30, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: monoclonal antibody SGN-30 (Biological)
Arm I (SGN-30, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: vinorelbine tartrate (Drug)
Arm I (SGN-30, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: pegylated liposomal doxorubicin hydrochloride (Drug)
Arm I (SGN-30, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: gemcitabine hydrochloride (Drug)
Arm I (SGN-30, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: laboratory biomarker analysis (Other)
Arm I (SGN-30, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: pharmacological study (Other)
Arm II (placebo, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: placebo (Other)
Arm II (placebo, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: vinorelbine tartrate (Drug)
Arm II (placebo, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: gemcitabine hydrochloride (Drug)
Arm II (placebo, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: laboratory biomarker analysis (Other)
Arm II (placebo, chemotherapy)
Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.
No prior stem cell transplant:
SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.
Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.
干预措施: pharmacological study (Other)
结局指标
主要结局
Number of Participants With Overall Response (OR)
时间窗: Up to 10 years
The number of participants who respond (complete or partial) to treatment. Response was defined using the revised criteria for malignant lymphoma. Complete response (CR): complete disappearance of all detectable disease; partial response (PR): \>= 50% reduction in sum of the product of diameters of indicator lesions.
次要结局
- Event Free Survival (EFS)(Up to 10 years)
- Overall Survival (OS) At 1 Year(1 year)