Non-Myeloablative Allogeneic Bone Marrow Transplantation for Hematologic Malignancies Using Haploidentical Donors: A Phase I Trial of Pre-Transplant Cyclophosphamide
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. Bone marrow transplantation may be able to replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill cancer cells.
PURPOSE: Phase I trial to study the effectiveness of cyclophosphamide plus bone marrow transplantation in treating patients who have hematologic cancer.
详细描述
OBJECTIVES:
- Determine the minimum effective dose of pretransplant cyclophosphamide to induce engraftment of haploidentical allogeneic bone marrow without the use of myeloablative conditioning in patients with hematologic malignancies.
- Determine the incidence and severity of graft versus host disease and nonhematologic toxicities with this treatment regimen in these patients.
- Correlate the pretreatment phenotypic and functional immunologic characteristics in these patients in relation to risk of graft rejection with this treatment regimen.
OUTLINE: This is a dose-escalation study of cyclophosphamide.
Patients receive fludarabine IV over 1 hour on days -6 to -2; cyclophosphamide IV over 1 hour on days -6, -5, and 3; total body irradiation on day -1; and allogeneic bone marrow transplantation on day 0. Patients also receive tacrolimus IV or orally twice a day on days 4-50; oral mycophenolate mofetil on days 4-35; and filgrastim (G-CSF) subcutaneously or IV starting on day 4 and continuing until blood counts recover.
Cohorts of 3-6 patients receive escalating doses of cyclophosphamide until the minimum effective dose necessary to induce chimerism without unacceptable toxicity in these patients is determined.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Patients with any of the following diagnoses:
- •Chronic myelogenous leukemia
- •Chronic phase 1
- •Failed prior interferon alfa therapy OR
- •Relapsed after prior autologous stem cell transplantation
- •Chronic phase 2
- •Acute leukemia
- •Standard risk
- •Age over 60 years
- •Complete remission 1 (CR1)
- •High risk
- •High WBC at presentation, unfavorable cytogenetics, mixed lineage, delayed response to induction chemotherapy
- •Complete remission 2 or higher
- •Acute lymphocytic leukemia
- •CR1 or higher
- •Myelodysplastic syndrome
- •Untreated OR
- •Acute myeloid leukemia in CR1
- •Chronic lymphocytic leukemia
- •Rai stage III or IV OR
- •Received prior autologous stem cell transplantation
- •Multiple myeloma
- •Stage II or III
- •Stable or progressive disease after prior chemotherapy OR
- •Received prior autologous stem cell transplantation
- •Non-Hodgkin's Lymphoma
- •Hodgkin's lymphoma
- •Ineligible for or refused autologous or standard allogeneic bone marrow transplantation
- •Ineligible for bone marrow transplantation from an HLA matched, sibling donor or from an HLA matched, unrelated donor
- •Must have an HLA mismatched, related donor (3-5 out of 6)
- •PATIENT CHARACTERISTICS:
- •0.5 to 70
- •Performance status:
- •Life expectancy:
- •Not specified
- •Hematopoietic:
- •Not specified
- •Bilirubin less than 3.1 mg/dL
- •Not specified
- •Cardiovascular:
- •Left ventricular ejection fraction at least 35%
- •FEV_1 and FVC at least 40% of predicted OR
- •FEV_1 and FVC at least 60% in patients who have received prior thoracic or mantle radiotherapy
- •HIV negative
- •No other debilitating medical or psychiatric illness that would preclude study compliance
- •Not pregnant
- •Negative pregnancy test
- •Fertile patients must use effective contraception
- •PRIOR CONCURRENT THERAPY:
- 另有 10 项未显示
排除标准
- 未提供