Sequential Conditioning in Haploidentical Transplantation for Hematopoietic Stem Cells in Patients With Relapsed or Refractory Lymphoid Hematological Disorders

• Status: Recruiting
• Trial end date: 2022-07-30
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Association for Training, Education, and Research in Hematology, Immunology, and Transplantation

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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