A Randomized Trial for Adults with Newly Diagnosed Acute Lymphoblastic Leukemia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,033
- 主要终点
- Event-free survival
研究概览
简要总结
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. It is not yet known which regimen of combination chemotherapy given together with or without monoclonal antibodies is more effective in treating patients with newly diagnosed acute lymphoblastic leukemia.
PURPOSE: This randomized phase III trial is studying standard chemotherapy to see how well it works when given together with or without rituximab, and with or without nelarabine in treating patients with newly diagnosed acute lymphoblastic leukemia.
详细描述
OBJECTIVES:
Primary
- To determine if the addition of a monoclonal antibody (none vs. rituximab) improves event-free survival (EFS) in patients with newly diagnosed precursor B-cell acute lymphoblastic leukemia (ALL).
- To determine if the addition of nelarabine improves outcome for patients with T-cell ALL.
Secondary
- To determine the tolerability of pegaspargase in induction therapy of all patients.
- To compare anti-asparaginase antibody levels in patients with B-lineage ALL.
- To determine whether risk-adapted introduction of unrelated donor hematopoietic stem cell transplantation (HSCT) (myeloablative conditioning in patients ≤ 40 years old and non-myeloablative conditioning in patients > 40 years old) results in greater EFS for patients at highest risk of relapse.
- To compare the efficacy of two schedules (standard vs collapsed) of palifermin in preventing severe mucosal toxicity in patients treated with etoposide, total-body irradiation, and HSCT-conditioning therapy.
- To assess the late effects of this treatment in these patients.
- To identify and describe some of the adverse physical and psychosocial consequences of this disease and its treatment.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: vincristine sulfate (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: cyclophosphamide (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: cyclophosphamide (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: cytarabine (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: daunorubicin hydrochloride (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: etoposide (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: fludarabine phosphate (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: imatinib mesylate (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: melphalan (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: mercaptopurine (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: methotrexate (Drug)
B1 - Standard therapy
Standard chemotherapy for precursor B-cell ALL
干预措施: pegaspargase (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: rituximab (Biological)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: cyclophosphamide (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: cytarabine (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: daunorubicin hydrochloride (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: etoposide (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: fludarabine phosphate (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: imatinib mesylate (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: melphalan (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: mercaptopurine (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: methotrexate (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: pegaspargase (Drug)
B2 - Rituximab
Standard chemotherapy for precursor B-cell ALL plus weekly rituximab infusions during phase 1 induction
干预措施: vincristine sulfate (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: cyclophosphamide (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: cytarabine (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: daunorubicin hydrochloride (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: etoposide (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: fludarabine phosphate (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: melphalan (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: mercaptopurine (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: methotrexate (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: pegaspargase (Drug)
T1 - Standard therapy
Standard chemotherapy for T-cell ALL
干预措施: vincristine sulfate (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: cytarabine (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: daunorubicin hydrochloride (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: etoposide (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: fludarabine phosphate (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: melphalan (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: mercaptopurine (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: methotrexate (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: nelarabine (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: pegaspargase (Drug)
T2 - Nelarabine
Standard chemotherapy for T-cell ALL plus an additional course of treatment with nelarabine following phase 2 induction
干预措施: vincristine sulfate (Drug)
P1 - standard palifermin
6 doses of palifermin before/after myeloablative stem cell transplant (randomisation closed due to lack of clinical relevance in 2016)
干预措施: palifermin (Biological)
P1 - standard palifermin
6 doses of palifermin before/after myeloablative stem cell transplant (randomisation closed due to lack of clinical relevance in 2016)
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
P1 - standard palifermin
6 doses of palifermin before/after myeloablative stem cell transplant (randomisation closed due to lack of clinical relevance in 2016)
干预措施: total-body irradiation (Radiation)
P2 - collapsed palifermin
1 x large dose of palifermin before myeloablative stem cell transplant and 3 low doses after transplant (randomisation closed due to lack of clinical relevance in 2016)
干预措施: palifermin (Biological)
P2 - collapsed palifermin
1 x large dose of palifermin before myeloablative stem cell transplant and 3 low doses after transplant (randomisation closed due to lack of clinical relevance in 2016)
干预措施: allogeneic hematopoietic stem cell transplantation (Procedure)
P2 - collapsed palifermin
1 x large dose of palifermin before myeloablative stem cell transplant and 3 low doses after transplant (randomisation closed due to lack of clinical relevance in 2016)
干预措施: total-body irradiation (Radiation)
结局指标
主要结局
Event-free survival
时间窗: 3 years
Time from randomisation to relapse or death from any cause
次要结局
- Complete remission (CR) rate(Throughout treatment)
- Minimal-residual disease quantification after first phase of induction and post-transplantation(Throughout treatment)
- Death in CR(3 years)
- Anti-asparaginase antibodies in patients treated with monoclonal antibody therapy(Throughout treatment)
- Overall survival(3 years)
- Relapse rate (including bone marrow and CNS relapse)(3 years)
- Toxicity related to pegaspargase(Throughout treatment)
- Mucositis score in patients treated with palifermin(30 days)