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

  • STATUS
    Recruiting
  • End date
    Jul 30, 2022
  • participants needed
    40
  • sponsor
    Association for Training, Education, and Research in Hematology, Immunology, and Transplantation
Updated on 24 January 2021

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

Details
Condition Refractory or Relapsed Lymphoid Haemopathy
Treatment Sequential Packaging (SET), Transfusion graft, Prevention of GVHD, Care supports, Lymphocyte injection of prophylactic donor (PDLI)
Clinical Study IdentifierNCT03079089
SponsorAssociation for Training, Education, and Research in Hematology, Immunology, and Transplantation
Last Modified on24 January 2021

Eligibility

Yes No Not Sure

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, waldenstrm'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
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