NCT00550992Unknown不适用
International Collaborative Treatment Protocol for Infants Under One Year With Acute Lymphoblastic or Biphenotypic Leukemia
Dutch Childhood Oncology Group26 个研究点 分布在 9 个国家目标入组 445 人开始时间: 2006年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 445
- 试验地点
- 26
- 主要终点
- Disease-free survival
研究概览
简要总结
RATIONALE: Giving chemotherapy before a donor stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells. Giving cyclosporine, methotrexate, leucovorin, and antithymocyte globulin before and after transplant may stop this from happening. It is not yet known which treatment regimen is most effective in treating acute leukemia.
PURPOSE: This randomized clinical trial is studying how well different therapies work in treating infants with newly diagnosed acute leukemia.
详细描述
OBJECTIVES:
Primary
- To compare an early intensification regimen comprising two "acute myeloid leukemia" induction therapy blocks with a standard protocol IB regimen administered directly after induction therapy in medium-risk (MR) and high-risk (HR) patients with newly diagnosed acute lymphoblastic or biphenotypic leukemia.
Secondary
- To compare through a randomized study the role of these regimens in treating these patients.
- To compare the overall outcome of the Interfant-06 study with outcomes in the historical control series, especially in the Interfant-99 study.
- To compare the outcomes of low-risk, MR, or HR patients in this study with those of patients in the historical control series Interfant-99 study.
- To study which factors have independent prognostic value in patients treated with these regimens.
- To assess the role of stem cell transplantation in HR patients.
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
- — 至 1 Year（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Inclusion criteria:
- •Diagnosis of acute lymphoblastic leukemia (ALL) or biphenotypic leukemia meeting the following criteria:
- •Based on European Group for the Classification of Acute Leukemia (EGIL) diagnostic criteria
- •Newly diagnosed disease
- •Verified by morphology and confirmed by cytochemistry and immunophenotyping
- •Trephine biopsy is recommended (unless diagnosis can be confirmed by peripheral blood examination) in the event that bone marrow aspiration results in a "dry tap"
- •Must have MLL gene rearrangements documented by split-signal fluorescence in situ hybridization and meets 1 of the following risk criteria:
- •Low-risk disease, defined as all MLL germline cases
- •Medium-risk disease, defined by 1 of the following criteria:
- •MLL status unknown
- •MLL rearranged AND age > 6 months
- •MLL rearranged AND age < 6 months AND WBC < 300 x 10^9/L AND prednisone good response
- •High-risk disease, defined by MLL rearrangement AND meets the following criteria:
- •Age at diagnosis < 6 months (i.e., < 183 days)
- •WBC ≥ 300 x 10^9/L AND/OR prednisone poor response
- •Minimum donor and stem cell requirements for high-risk patients undergoing stem cell transplantation:
- •Donor meeting 1 of the following criteria:
- •HLA-identical sibling
- •Very well-matched related or unrelated donor
- •Must be HLA compatible in 10/10 or 9/10 alleles by 4 digit/allele high-resolution molecular genotyping
- •Stem cell source
- •Bone marrow (preferred source) OR peripheral blood stem cells of filgrastim [G-CSF]-stimulated donors OR cord blood
- •Highly-matched unrelated umbilical cord blood (UCB) (> 7/8 matches identified by high-resolution typing) accepted if a sibling donor is not able to donate bone marrow AND UCB with a sufficient number of nucleated cells (NCs) (i.e., > 1.5 x 10^7/kg recipient body weight [BW]) is cryopreserved
- •Must have ≥ 3 x 10^8 NCs/kg BW OR 3 x 10^6/kg BW CD34-positive cells available for transplantation
- •CNS or testicular leukemia at diagnosis allowed
排除标准
- •Mature B-ALL, defined by the immunophenotypical presence of surface immunoglobulins or t(8;14) and breakpoint as in B-ALL
- •Presence of the t(9;22) (q34;q11) or bcr-abl fusion in the leukemic cells (if data are not known, patient still may be eligible)
- •Relapsed ALL
- •PATIENT CHARACTERISTICS:
- •See Disease Characteristics
- •PRIOR CONCURRENT THERAPY:
- •More than 4 weeks since prior systemic corticosteroids
- •Corticosteroids by aerosol are allowed
结局指标
主要结局
Disease-free survival
次要结局
- Event-free survival
- Survival
- Event-free survival within each risk group (i.e., low-risk, medium-risk, or high-risk)
研究者
研究点 (26)
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