Dose Finding Study of Gelonin Purging of Autologous Stem Cells for Transplantation of Patients With AML/MDS in First or Subsequent Remission
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Optimal Dose Gelonin
研究概览
简要总结
Patients with Acute Myelogenous Leukemia or Myelodysplastic are able to achieve a complete remission but fail to achieve a prolonged disease-free survival. High dose chemotherapy and autologous bone marrow transplantation has been shown to be effective in this group of patients but hematopoietic recovery is slow, and infectious or bleeding complications are common. The delay in hematopoietic recover is accentuated by the use of purging techniques. This is a novel purging approach for autologous stem cell transplantation in patients with Acute Myelogenous Leukemia or Myelodysplastic syndrome to allow for rapid engraftment with a lower relapse rate therefore improving the therapeutic outcomes
详细描述
Treatment:
The HuM195-Gelonin conjugate has been designed to target leukemia cells and destroy them.
This treatment is divided into 3 parts.
Part I:
MOBILIZATION and STEM CELL COLLECTION:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •Patients with AML, RAEB-t, RAEB, or CMML who are in first remission and have poor prognosis cytogenetic abnormalities (i.e: deletions of chromosome 5, 7, 20; trisomy 8, t9,22,11q23 abnormalities or complex karyotypes).*
- •Patients with AML, RAEB-t, RAEB, or CMML who are in second or subsequent remission.
- •Remission is defined as ANC>1.5 x 109/Lt; Platelet count >100 x 109/Lt, and red cell transfusion independence.
- •Male or female who have provided written informed consent.
- •Tumor cells must be > 80 % CD-33 positive by flow cytometry.
- •For women of childbearing potential (i.e., exclude post-menopausal women, women who have been surgically sterilized), adequate birth control methods must be used. Acceptable birth control methods are limited to oral contraceptives, implants, diaphragm, IUD or spermicide used with a condom)
- •No chemotherapy for the two weeks prior to entering the study.
- •No evidence of residual toxic effects from prior chemotherapy.
- •Patients with proven bacterial infection are not eligible until resolution of the infection (patient afebrile, not on steroids). Patients with active fungal infections are eligible only if evidence of response to antifungal medications is documented and they do not have fever exceeding 38C.
- •Must have at least 5 x 106 CD34+ peripheral blood stem cells collected.
- •All patients who have had less than 7 x 106 CD34+ cells/kg collected, should have a bone marrow harvest to serve as back-up.
- •A minimum of 1 x 106 CD34+ cells/kg of unpurged bone marrow or 2 x 106 CD34+ cells/kg of unpurged peripheral blood need to be stored as backup to be eligible for this protocol.
- •Patients must have bilirubin less than 2.0, transaminases less than 4 x upper limit of normal.
- •Pulmonary function tests >50% predicted for DLCO, FVC and FEV1
- •No active uncontrolled infection
- •No active CNS disease
- •No uncontrolled arrythmias
- •Zubrod Performance Status less than or equal to 2
排除标准
- •Active CNS disease
研究组 & 干预措施
Gelonin Purging of ASCT
Gelonin Purging of Autologous Stem Cells for Transplantation (ASCT) + Fludara/Busulfan
干预措施: Gelonin (Procedure)
Gelonin Purging of ASCT
Gelonin Purging of Autologous Stem Cells for Transplantation (ASCT) + Fludara/Busulfan
干预措施: Busulfan (Drug)
Gelonin Purging of ASCT
Gelonin Purging of Autologous Stem Cells for Transplantation (ASCT) + Fludara/Busulfan
干预措施: Fludarabine (Drug)
结局指标
主要结局
Optimal Dose Gelonin
时间窗: 28 days post transplant
Dose-finding success, defined as patient alive and engrafted at day 28 post transplant, represented as number of patient successes with 3 differing doses (5, 10, or 15 nanomolar (nm) gelonin-antiCD33 purged autologous stem cells after a high dose fludarabine/busulfan conditioning regimen).
次要结局
未报告次要终点