drugset / Trial / NCT03079089

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

NCT03079089

NaSingle-groupOpen-labelOther

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

Timeline

Start
2017-06-30
Primary completion
2023-09-11
Completion
2023-09-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Busulfan Small molecule 3.2 mg/kg Intravenous
Subject Cyclophosphamide Other / unclassified 50 mg/kg
Subject Cyclophosphamide Other / unclassified 400 mg/m2
Subject Etoposide Small molecule 100 mg/m2
Subject Fludarabine Small molecule 30 mg/m2
Subject Thiotepa Other / unclassified 5 mg/kg
Subject Thymoglobulin Protein / enzyme biologic 2.5 mg/kg
Background Cyclosporine Peptide 3 mg/kg Intravenous
Background Mycophenolate Mofetil Small molecule 30 mg/kg

Indications