Fludarabine Based Conditioning for Allogeneic Transplantation for Advanced Hematologic Malignancies
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Number of Participants With Engraftment.
研究概览
简要总结
New conditioning regimens are still needed to maximize efficacy and limit treatment-related deaths of allogeneic transplantation for advanced hematologic malignancies. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.
详细描述
Treatment-related mortality and recurrence of disease account for the majority of treatment failures in allogeneic transplantation for advanced hematologic malignancies. The most commonly utilized conditioning regimens consist of cyclophosphamide and total-body irradiation or busulfan and cyclophosphamide. Other agents such as etoposide or thiotepa are sometimes added to maximize the antileukemic effect. New conditioning regimens are however still needed to maximize efficacy and limit treatment-related deaths. Over the past several years, the investigators have evaluated several new conditioning regimens that incorporate fludarabine, a novel immunosuppressant that has limited toxicity and that has synergistic activity with alkylating agents. Recent data have suggested that fludarabine may be used in combination with standard doses of oral or IV busulfan, thus reducing the toxicity previously observed with cyclophosphamide/ busulfan regimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 10 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with the following diseases:
- •Acute myeloid or lymphocytic leukemia in first remission at standard or high-risk for recurrence.
- •Acute leukemia in greater than or equal to second remission, or with early relapse, or partial remission.
- •Chronic myelogenous leukemia in accelerated phase or blast-crisis.
- •Chronic myelogenous leukemia in chronic phase
- •Recurrent or refractory malignant lymphoma or Hodgkin's disease
- •Multiple myeloma.
- •Chronic lymphocytic leukemia, relapsed or with poor prognostic features.
- •Myeloproliferative disorder (polycythemia vera, myelofibrosis) with poor prognostic features.
- •Severe aplastic anemia after failure of immunosuppressive therapy.
- •Age 10-65 years.
- •Zubrod performance status less than or equal to
- •Adequate cardiac and pulmonary function. Patients with decreased LVEF < 40% or DLCO < 50% of predicted will be evaluated by cardiology or pulmonary prior to enrollment on this protocol.
- •Patient or guardian able to sign informed consent.
排除标准
- •Life expectancy is severely limited by concomitant illness.
- •Serum creatinine greater than 1.5 mg/dL or Creatinine Clearance less than 50 ml/min .
- •Serum bilirubin greater than or equal to 2.0 mg/dl, SGPT greater than 3 x upper limit of normal
- •Evidence of chronic active hepatitis or cirrhosis
- •HIV-positive
- •Patient is pregnant
研究组 & 干预措施
Arm 1
All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
干预措施: fludarabine/busulfan (Drug)
Arm 1
All patients below age 55 should receive fludarabine/busulfan and ATG in case of unrelated or mismatched donor.
干预措施: ATG (Drug)
Arm 2
All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
干预措施: fludarabine/ melphalan (Drug)
Arm 2
All patients above age 55 or below age 65 should receive fludarabine/ melphalan and ATG.
干预措施: ATG (Drug)
结局指标
主要结局
Number of Participants With Engraftment.
时间窗: Up to 30 days post-transplant
Median time to ANC engraftment and platelet engraftment in both groups as well as the transfusion requirements measured within 30 days after transplant.
次要结局
- Participants With 100 Day Transplant-related Mortality.(Up to 100 days post-transplant.)
- Time to ANC and Platelet Engraftment(Up to 30 days post-transplant)
- Number of Participants With Moderate to Severe (Grade 2-4) Acute Graft Versus Host Disease (GVHD).(Up to 100 days post-transplant (acute GVHD).)
研究者
Damiano Rondelli, MD
Professor
University of Illinois at Chicago