A Randomized Phase III Study to Evaluate Benefits of Autologous Stem Cell Transplant in Patients With Peripheral T Cell Lymphoma That Achieved a First Complete Remission (CR1) Following Induction Therapy (PTCL-STAT)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 294
- 试验地点
- 168
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.
详细描述
PRIMARY OBJECTIVE:
I. To demonstrate improvement in progression free survival (PFS) in the autologous stem cell transplant (ASCT) arm compared to the observation arm.
SECONDARY OBJECTIVES:
I. To assess difference in overall survival (OS) between the observation and autologous stem cell transplant (ASCT) arm.
II. To evaluate the differences in study intervention benefit for PFS and OS by the randomization stratification factors (histology and choice of induction chemotherapy).
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18 to 75 years of age
- •Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- •Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of the following categories:
- •Anaplastic large cell lymphoma (ALCL) ALK-negative
- •Angioimmunoblastic T-cell lymphoma (AITL)
- •Nodal PTCL with follicular helper T cell (TFH) phenotype
- •Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
- •Patient must have undergone induction treatment with an anthracycline based chemotherapy.
- •NOTE: Patients who discontinued anthracycline during treatment are eligible as long as they received at least one dose and achieved complete remission
- •Patient must have achieved radiologic complete remission following induction therapy as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT
- •NOTE: There is no central review required. Confirmation of complete remission status is determined by the enrolling institution's review
- •NOTE: If a patient had a positive bone marrow biopsy at the time of initial diagnosis (pre-induction), a repeat biopsy must be completed post induction to confirm complete remission (CR)
- •Patient must be eligible for high dose chemotherapy and autologous stem cell transplant (ASCT) per the enrolling institutional guidelines at the transplant center and be ready to proceed with ASCT if randomized to the ASCT arm
- •Patient must not have active infection requiring intravenous systemic antimicrobial at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose of the medication has been stable for at least 7 days prior to randomization
- •Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
- •Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)
- •Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse during the treatment phase of the study and thereafter according to institutional guidelines
- •Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol randomization)
- •Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization)
- •Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14 days prior to protocol randomization)
- •Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤ 3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization)
- •Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial
- •For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
- •Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
排除标准
- 未提供
研究组 & 干预措施
Arm I (observation)
Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Positron Emission Tomography (Procedure)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Autologous Hematopoietic Stem Cell Transplantation (Procedure)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Leukapheresis (Procedure)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Stem Cell Mobilization Therapy (Drug)
Arm I (observation)
Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Computed Tomography (Procedure)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Bone Marrow Aspiration (Procedure)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Bone Marrow Biopsy (Procedure)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Computed Tomography (Procedure)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: High Dose Chemotherapy (Drug)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Positron Emission Tomography (Procedure)
Arm I (observation)
Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Best Practice (Other)
Arm I (observation)
Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Bone Marrow Aspiration (Procedure)
Arm II (high dose chemotherapy and ASCT)
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Biospecimen Collection (Procedure)
Arm I (observation)
Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Bone Marrow Biopsy (Procedure)
Arm I (observation)
Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study.
干预措施: Biospecimen Collection (Procedure)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: From study randomization to documented disease progression or death, whichever occurs first, assessed up to 12 years
Stratified logrank test will be used for the primary analysis of the comparison of PFS between treatment arms. Kaplan-Meier method will be used to visualize and estimate survival function for failure time endpoints. There will be a subgroup analysis for the randomization stratification factors, and other variables measured at baseline.
次要结局
- Overall survival (OS)(From study randomization to death due to any cause, assessed up to 12 years)
- Cumulative incidence of relapse(Up to 12 years)
- Cumulative incidence of mortality(Up to 12 years)