Safety and Tolerability of Myeloablative Conditioning and Autologous Stem Cell Transplantation Followed by Polatuzumab Vedotin (PV) Immunoconjugate Therapy in Patients With B-cell Non-Hodgkin and Hodgkin Lymphoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Safety and tolerability
研究概览
简要总结
Patients will receive one of two conditioning regimens (BEAM or CBV) before receiving an autologous stem cell transplant (ASCT). If patients achieve either complete, partial, or stable response following ASCT, they will receive an IV dose of Polatuzumab Vedotin once every 21 days until they receive 8 doses. After Polatuzumab Vedotin therapy is completed, patients will be followed every 4 months for about 2 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis B-cell NHL: Burkitt lymphoma, Diffuse Large B Cell Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma, Transformed Follicular Lymphoma, Richter syndrome, and CD20+ Hodgkin Lymphoma.
- •Disease Status Primary Induction Failure, 1st, 2nd or 3rd relapse/progression having attained a CR, PR, or stable disease post reinduction therapy.
- •Performance Level Patients must have a performance status ≥ 50%. Use Karnofsky for patients > 16 years of age and Lansky for patients less than or equal to 16 years of age. See Appendix I for performance score.
- •Life Expectancy Patients must have a life expectancy of > 6 weeks.
- •Prior Therapy Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
- •Myelosuppressive chemotherapy: Must not have received within 2 weeks of entry onto this study (4 weeks if prior nitrosourea).
- •Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent.
- •Organ Function Requirements
- •Adequate Renal Function Defined As:
- •Creatinine clearance or radioisotope GFR > 60 mL/min/1.73 m2 or
- •A serum creatinine based on age/gender as follows:
- •Age Maximum Serum Creatinine (mg/dL) Male Female
- •12 to < 13 years 1.2 1.2 13 to < 16 years 1.5 1.4
- •16 years 1.7 1.4
- •Adequate Liver Function Defined As:
- •Total bilirubin less than or equal to 1.5 x upper limit of normal (ULN) for age, and
- •SGOT (AST) or SGPT (ALT) < 3 x upper limit of normal (ULN) for age for presumed hepatic leukemia or lymphoma.
- •Adequate Cardiac Function Defined As:
- •Shortening fraction of > 27% by echocardiogram, or
- •Ejection fraction of > 50% by radionuclide angiogram.
- •Adequate Pulmonary Function Defined As:
- •Normal respiratory rate for age and a pulse oximetry > 94% on room air unless due to underlying malignancy.
- •Peripheral Blood Stem Cell Collection
- •Patients have a target of 5.0 x 106 CD34 (minimum of 2.5 x 106 CD34) PBSC collected and cryopreserved prior to start of myeloablative conditioning
- •All patients and/or their parents or legal guardians must sign a written informed consent.
排除标准
- •Patient may not have had a prior stem cell transplant
- •Patients must not have active CNS lymphoma
- •Other concurrent investigational agents for treatment of B-cell lymphoma
- •Pregnancy and/or active Breast Feeding
- •Sexually active patients of reproductive potential are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation.
- •Patient must not have an uncontrolled infection.
- •Patient must not have ≥ Grade 3 neuropathy.
研究组 & 干预措施
Polatuzumab vedotin
Evaluable patients for safety Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety.
Evaluable patients for response Only in patients who are in PR or SD prior to PV and received a minimum of 3 doses will be evaluable.
Evaluable patients for EFS, PFS, OS All patients who have completed conditioning and autoSCT will be evaluable for EFS, PFS, and OS.
干预措施: Polatuzumab vedotin (Drug)
结局指标
主要结局
Safety and tolerability
时间窗: 1 year
To evaluate the safety and tolerability of Polatuzumab vedotin (PV) immunoconjugate therapy post myeloablative conditioning (MAC) and autologous stem cell transplantation (AutoSCT) in patients with B-cell non-Hodgkin lymphoma (NHL). Patients receiving 1 dose of Polatuzumab Vedotin will be evaluable for safety. To determine the safety events: Number of participants with treatment-related Grade III or higher adverse events as assessed by CTCAE v5.0. To determine the occurrence of any Grade ≥ 3 non hematologic toxicity (per CTCAE v.5) which is possibly, probably, or definitely related to polatuzumab vedotin.
次要结局
- EFS, PFS, and OS(2 years)
- ORR(2 years)