NCT00110058已完成2 期
A Multi-Center Phase II Study of Nonmyeloablative Conditioning With TBI and Fludarabine for HLA-Matched Related Hematopoietic Cell Transplantation for Treatment of Chronic Myeloid Leukemia in Chronic and Accelerated Phase
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 6
- 主要终点
- Progression-free survival
研究概览
简要总结
RATIONALE: Giving low doses of chemotherapy, such as fludarabine, and radiation therapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also stops the patient's immune system from rejecting the donor's stem cells. The donated stem cells may replace the patient's immune system and help destroy any remaining cancer cells (graft-versus-tumor effect). Giving an infusion of the donor's T cells (donor lymphocyte infusion) or interferon alfa after the transplant may help increase this effect. Sometimes the transplanted cells from a donor can also make an immune response against the body's normal cells. Giving cyclosporine and mycophenolate mofetil after the transplant may stop this from happening.
PURPOSE: This phase II trial is studying how well giving fludarabine together with radiation therapy works in treating patients who are undergoing donor stem cell transplant for chronic phase or accelerated phase chronic myelogenous leukemia.
详细描述
OBJECTIVES:
Primary
- Determine the disease-free survival rate in patients with chronic or accelerated phase chronic myelogenous leukemia that failed or inadequately responded to prior imatinib mesylate treated with nonmyeloablative conditioning comprising fludarabine and low-dose total-body irradiation followed by allogeneic peripheral blood stem cell transplantation.
Secondary
- Determine the complete cytogenetic and molecular response rates in patients treated with this regimen.
- Determine overall survival of patients treated with this regimen.
- Determine non-relapse mortality in patients treated with this regimen.
- Determine the incidence of serious infection, graft-versus-host disease, and myelosuppression in patients treated with this regimen.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Diagnosis of Philadelphia chromosome-positive (Ph+) chronic myelogenous leukemia, meeting 1 of the following criteria:
- •Chronic phase
- •Ph+ by cytogenetics or fluorescent in situ hybridization (FISH) assay
- •Accelerated phase, meeting any of the following criteria:
- •More than 10% but < 30% myeloblasts and promyelocytes in marrow or peripheral blood
- •Any additional clonal cytogenetic abnormalities
- •Increasing splenomegaly
- •Extramedullary tumor
- •WBC, platelet count, or hematocrit perturbations not controlled by therapy with hydroxyurea, interferon, or imatinib mesylate
- •Persistent unexplained fever or bone pain
- •Less than 5% blasts in the marrow at time of transplantation
- •Not eligible for OR refused conventional myeloablative allogeneic stem cell transplantation
- •Failed OR suboptimal response to prior imatinib mesylate, as defined by 1 of the following:
- •Absence of complete hematologic response after > 3 months of treatment with imatinib mesylate
- •Absence of cytogenetic response, as defined by 1 of the following:
- •Absence of any cytogenetic response (< 95% Ph+ or BCR/ABL+ cells by cytogenetic or FISH analysis, respectively) after 6 months of treatment with imatinib mesylate
- •Absence of major cytogenetic response (< 35% Ph+ or BCR/ABL+ cells by cytogenetic or FISH analysis, respectively) after 1 year of treatment with imatinib mesylate
- •Absence of complete cytogenetic response (no Ph+ cells by cytogenetic analysis OR BCR/ABL+ cells within normal limits by FISH analysis) after 18 months of treatment with imatinib mesylate
- •Hematologic evidence of disease progression
- •Cytogenetic evidence of disease progression
- •Increase in Ph+ cells or BCR/ABL+ cells by > 20% with at least 1 month between sequential testing
- •Molecular evidence of disease progression
- •More than 10-fold increase in BCR/ABL mRNA levels by quantitative polymerase chain reaction (Q-PCR) with at least 1 month between 2 sequential tests
- •Experienced adverse events during treatment with imatinib mesylate that precluded further administration of the drug
- •No CNS disease refractory to intrathecal chemotherapy
- •HLA identical related donor available
- •Phenotypically matched at HLA-A, -B, -C, DRQ1, and DBQ1
- •No presence of circulating leukemic blasts by standard pathology
- •PATIENT CHARACTERISTICS:
- •Performance status
- •Karnofsky 70-100% OR
- •Lansky 70-100%
- •Life expectancy
- •Not specified
- •Hematopoietic
- •See Disease Characteristics
- •No fulminant liver failure
- •No cirrhosis of the liver with evidence of portal hypertension or bridging fibrosis
- •No alcoholic hepatitis
- •No esophageal varices
- •No history of bleeding esophageal varices
- •No hepatic encephalopathy
- •No uncorrectable hepatic synthetic dysfunction evidenced by prolongation of PT
- •No ascites related to portal hypertension
- •No bacterial or fungal liver abscess
- •No biliary obstruction
- •No chronic viral hepatitis AND bilirubin > 3 mg/dL
- •No symptomatic biliary disease
- •Renal failure allowed
- 另有 29 项未显示
排除标准
- 未提供
结局指标
主要结局
Progression-free survival
次要结局
- Rate of complete molecular response
- Late nonrelapse mortality
- Incidence and severity of graft-vs-host disease (GVHD)
- Incidence of serious infections
- Myelosuppression
- Overall survival and disease-free survival
研究者
研究点 (6)
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