NCT00005802已完成1 期
Chemotherapy (CT) Followed by Donor Lymphocyte Infusion (DLI) Plus Interleukin 2 (IL-2) for Patients With Relapse Acute Myeloid or Lymphoid Leukemia After Allogeneic Hematopoietic Transplant
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing so they stop growing or die. Interleukin-2 may stimulate a person's white blood cells to kill leukemia cells. Treating donor white blood cells with interleukin-2 in the laboratory may help them kill more cancer cells.
PURPOSE: This phase I/II trial is studying the side effects and best dose of interleukin-2 when given after chemotherapy and donor white blood cells and to see how well they work in treating patients with acute myeloid leukemia or acute lymphoid leukemia.
详细描述
OBJECTIVES:
- Determine the maximum tolerated dose of interleukin-2 following donor lymphocyte infusion and chemotherapy in patients with relapsed acute myeloid or lymphoid leukemia after allogeneic peripheral blood stem cell transplantation.
- Determine the toxicity and efficacy of this regimen in these patients.
OUTLINE: This is a dose escalation study of interleukin-2 (IL-2). Patients are stratified according to disease status after chemotherapy (acute myeloid leukemia (AML) in complete remission (CR) vs acute lymphoid leukemia (ALL) or AML not in CR).
Patients receive one of three induction chemotherapy regimens, depending on type of leukemia, prior treatment, and response.
- Regimen 1: Patients receive high dose cytarabine IV over 2 hours twice a day on days 1, 3, and 5.
- Regimen 2: Patients receive mitoxantrone IV over 15 minutes and etoposide IV over 30 minutes on days 1-5.
- Regimen 3: Patients receive fludarabine IV over 30 minutes on days 1-5, cytarabine IV over 2 hours on days 1-4, and filgrastim (G-CSF) subcutaneously beginning on day 1 and continuing until blood counts recover.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Relapsed acute myeloid leukemia or acute lymphoid leukemia after allogeneic peripheral blood stem cell transplantation (PBSCT), documented by 1 of the following:
- •Morphologic relapse defined as 1 or more of the following:
- •Peripheral blasts in absence of growth factor therapy
- •Bone marrow blasts greater than 5% of nucleated cells
- •Extramedullary (CNS, testicular, or other sites)
- •Flow cytometric relapse defined as appearance in peripheral blood or bone marrow of cells with abnormal immunophenotype consistent with leukemia recurrence and noted at pretransplant
- •Cytogenetic relapse defined as:
- •Appearance in 1 or more metaphases from bone marrow or peripheral blood cells of nonconstitutional cytogenetic abnormality noted in at least 1 cytogenetic study performed prior to transplant OR
- •New abnormality known to be associated with leukemia
- •Allogeneic PBSCT from related (HLA identical and 1 antigen mismatch) OR unrelated (match) donor
- •Must have achieved complete remission after PBSCT
- •Current donor must be same as prior donor
- •Age 10 and over
- •PATIENT CHARACTERISTICS:
- •Not specified
- •Performance status:
- •Life expectancy:
- •At least 3 months
- •Hematopoietic:
- •See Disease Characteristics
- •Bilirubin no greater than 2.0 mg/dL
- •Creatinine no greater than 2.0 mg/dL
- •Cardiovascular:
- •No congestive heart failure requiring diuretics
- •No uncontrolled arrhythmia
- •No pulmonary dysfunction requiring oxygen therapy
- •No pneumonia or severe obstruction
- •FEV_1 at least 50% of predicted OR no greater than 50% decline from baseline
- •No severe restrictive lung disease (total lung capacity less than 60% or 50% declined from baseline) not due to leukemia
- •No sepsis, aspergillosis, or other active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •Chemotherapy:
- •Not specified
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •Not specified
- •Not specified
- •No concurrent cyclosporine or tacrolimus during induction chemotherapy
排除标准
- 未提供
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Bone Marrow Transplantation in Treating Patients With Chronic Lymphocytic LeukemiaLeukemiaNCT00002844M.D. Anderson Cancer Center49
已完成
1 期
Chemotherapy Plus Donor White Blood Cell Infusion in Treating Patients With Relapsed Hematologic Cancer Following Donor Peripheral Stem Cell TransplantationMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesLymphomaLeukemiaNCT00005946University of Maryland, Baltimore
已完成
1 期
Combination Chemotherapy Plus Infusion of White Blood Cells in Treating Patients With Hematologic CancerMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative DiseasesLymphomaLeukemiaNCT00003243Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
已完成
2 期
Chemotherapy, Radiation Therapy, and Umbilical Cord Blood Transplantation in Treating Patients With Hematologic CancerMyelodysplastic SyndromesMultiple Myeloma and Plasma Cell NeoplasmGraft Versus Host DiseaseLymphomaLeukemiaNCT00003270Roswell Park Cancer Institute20
已完成
2 期
Chemotherapy Plus Biological Therapy Followed By Peripheral Stem Cell Transplantation in Treating Patients With Hematologic CancerMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesLymphomaLeukemiaNCT00004145University of Chicago16