EUCTR2013-005446-11-DE进行中（未招募）1 期
A prospective phase I/II study to investigate the feasibility, safety and efficacy of IL-15 activated cytokine induced killer (CIK) cells in relapsing patients with acute leukemia or myelodysplastic syndromes after allogeneic stem cell transplantation
Goethe-University Frankfurt0 个研究点目标入组 40 人开始时间: 2014年9月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Acute leukemia and MDS patients with cytogenetic relapse or detectable MRD in peripheral blood (PB) or bone marrow (BM) samples obtained during monitoring for relapse after allogeneic SCT. Increasing MRD levels or levels = 10-4 of BCR-ABL/ABL ratio or Ig/TCR gene rearrangements will trigger CIK cell intervention in ALL patients.
- •Acute leukemia and MDS patients with MC = 1% of autologous signals in PB samples confirmed by another PB or BM sample within one week. Patients with MC = 1% of autologous signals in CD33+ and CD34+ subpopulations in PB samples confirmed by BM analyses within one week. Acute leukemia and MDS patients with MC = 1% of autologous signals including signals in CD33+ and CD34+ subpopulations in BM samples.
- •Acute leukemia and MDS patients with hematologic relapse = day 120 after allogeneic stem cell transplantation eligible for chemotherapy with less than 5% malignant cells in bone marrow analyses performed after cytoreductive chemotherapy. Re-induction chemotherapy regime will be offered per investigator`s choice.
- •Patients without immunosuppressive agents and steroids.
- •Patients without additional than pre-existing chemo- or immune modulatory therapy
- •Patients with < grade II GvHD.
- •Patients with karnowsky or lansky performance status = 50%.
- •Patients and/or his/her legal representative having reviewed the patient information/informed consent form and have had their questions answered and have given written informed consent.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 20
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •Acute leukemia and MDS patients with hematologic relapse before day 120 or patients not eligible or without significant response to re-induction chemotherapy.
- •Patients with immunosuppressive agents or steroids.
- •Patients with additional than pre-existing chemo- or immune modulatory therapy
- •Patients with = grade II GvHD.
- •Patients with karnowsky or lansky performance status < 50%.
- •Patients and/or his/her legal representative having reviewed the patient information/informed consent form and have had their questions answered and have not given written informed consent.
研究者
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