Sequential Chemotherapy Prior Conditioning Reduced Intensity: Study Routine Care in Haploidentical Allogeneic Hematopoietic Stem Cells in Patients With Relapsed or Refractory Lymphoid Hematological Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall survival (OS)
研究概览
简要总结
Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option with a significant chance of healing in lymphoid hematological refractory or multiple relapses after chemotherapy. However, all patients with an indication of allo-HSC can not benefit because of two limitations: the toxicity of the treatment and graft shortage available.
For patients refractory or in relapses with an indication of allo-HSC, used the combinaison of an SET followed by the reduced-intensity allo-HSC (RIC) has shown some interesting results.
A post-transplant immune modulation with prophylactic injections of donor lymphocytes (PDLI) showed its effectiveness to decrease the risk of relapse while having a lower toxicity than chemotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication of allo-HSC for a lymphoid hematological malignancy like Hodgkin's lymphoma, non hodgkin's lymphoma b cell (mantle follicular, diffuse large cells, marginal zone,MALT) or T (peripheral T whithout specificity, anaplasic, angio-immunoblastic, natural killer cells, gamma / delta T cells, Sezary's syndrome, primitive cutaneous T), prolymphocytic leukemia, chronic lymphocytic leukemia, waldenström's disease and for which a therapeutic strategie combining a sequential chemotherapy followed by the reduced-intensity conditioning(SET RIC + PDLI) is decided
- •Patients at least in partial response (standard criteria) after a rescue treatment the day of evaluation at 1 month before the conditioning
- •Advanced age ≥ 18 to <60 years
- •Cardiac ejection fraction of the left ventricle ≥ 45%
- •Lung function - free diffusion capacity for carbon monoxide ≥ 50% of predicted value
- •Creatinine clearance ≥ 50 ml / min depending on the CKD-EPI formula
- •Availability of an HLA haploidentical donor in the family
- •Collection of non-opposition
排除标准
- •Invasion of uncontrolled CNS
- •Availability of an HLA identical family donor who agreed to donate hematopoietic stem cells OR non-related donor HLA-compatible 10/10 on HLA-A alleles, B, C, and DRB1 DQB1 available and ready to give in 4 weeks to make a decision allograft
- •Presence in the patient HLA-specific antibodies directed against an antigen HLA haploidentical donor family
- •Karnofsky score <70%
- •Patient HIV positive
- •Hepatitis B or C or chronic active
- •Uncontrolled infection at the time of start packing
- •Contraindication to the use of treatments provided by the protocol
- •Previous history of allo-HSC
- •No beneficiary of a social security scheme.
- •life expentancy estimated less than 1 month by investigator
研究组 & 干预措施
Relapsed or refractory lymphoid hematological disorders
Patients in refractory or relapses with an indication of allo-HSC used the combination of an SET followed by the RIC with the PDLI
干预措施: Sequential Packaging (SET) (Drug)
Relapsed or refractory lymphoid hematological disorders
Patients in refractory or relapses with an indication of allo-HSC used the combination of an SET followed by the RIC with the PDLI
干预措施: Transfusion graft (Drug)
Relapsed or refractory lymphoid hematological disorders
Patients in refractory or relapses with an indication of allo-HSC used the combination of an SET followed by the RIC with the PDLI
干预措施: Prevention of GVHD (Drug)
Relapsed or refractory lymphoid hematological disorders
Patients in refractory or relapses with an indication of allo-HSC used the combination of an SET followed by the RIC with the PDLI
干预措施: Care supports (Drug)
Relapsed or refractory lymphoid hematological disorders
Patients in refractory or relapses with an indication of allo-HSC used the combination of an SET followed by the RIC with the PDLI
干预措施: Lymphocyte injection of prophylactic donor (PDLI) (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: 2 years after transplantation
Describe efficacy and safety of the combination of an SET followed by the RIC with post-transplant immune modulation by PDLI in patients with refractory or relaps lymphoid hematological refractory or multiple relapses lymphoid hematological disorders
次要结局
- Cumulative incidence of acute and chronic graft against host disease (GVHD)(100 days and then 12 and 24 months after transplantation)
- Tolerance of this therapeutic strategy(90 days and the 6, 12 and 24 month after transplantation)
- Cumulative incidence of death not related to relapse(90 days and then 12 and 24 months after transplantation)
- Number of patients for whom PDLI was possible and number PDLI / patient ; incidence, severity and treatment of possible secondary GVHD in these patients(2 years after transplantation)
- Immune reconstitution post-transplantation in the peripheral blood(30, 90 and 180 days after transplantation)
- Partial or complete remission rate by standard criteria relapse incidence and death related to the disease and free survival(90 days and then 6, 12 and 24 months after transplantation)
研究者
Pr Mohamad MOHTY
Principal investigator
Association for Training, Education, and Research in Hematology, Immunology, and Transplantation