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Sequential Conditioning in Haploidentical Transplantation for Refractory Acute Myeloid Leukemia

NCT03035422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2022-07-25

No results posted yet for this study

Summary

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) is the only treatment option with a significant chance of healing in acute myeloid leukemia (AML) or refractory 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.

Conditions

  • Refractory Acute Myeloid Leukemia

Interventions

DRUG

Sequential Packaging (SET)

Sequential chemotherapy: * Thiotepa 5 mg / kg / day for 1 day (D-13) * Cyclophosphamide 400 mg / m² / day for 4 days (J-12 to J-9) * Etoposide 100 mg / m² / day for 4 days (J-12 to J-9) Repos days J-8 and J-6 Reduced-intensity conditioning (RIC) * Fludarabine 30 mg / m² / day for 5 days (J-5 to D-1) * Busulfan IV 3.2 mg / kg / day for 2 days (J-5 and J-4) * Anti-lymphocyte serum (Thymoglobuline) 2.5 mg / kg / day for 2 days (J-3 and J-2)

DRUG

Transfusion graft

Graft of peripheral stem cells is preferred at D0

DRUG

Prevention of GVHD

* Cyclophosphamide 50mg / kg / day on days D + 3 and D + 5 * Cyclosporine A (CSA; 3 mg / kg / day IV from D + 6) * Mycophenolate mofetil (MMF; 30 mg / kg / day, maximum x2 1g / day from day J + 6)

DRUG

Care supports

According to the protocols of each center

DRUG

Lymphocyte injection of prophylactic donor (PDLI)

According to the protocols of each center. In the absence of clinical indication against-disease (GVHD), phasing MMF between days D + 35 and D + 56, then phasing APF between D + 62 and D + 90 \- PDLI: 3 injections from the D + 120 patients who discontinued immunosuppressive therapy for ≥ 1 month and having no active GVHD or history of acute GVHD grade\> II

Sponsors & Collaborators

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

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-15
Primary Completion
2021-12-18
Completion
2021-12-18

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03035422 on ClinicalTrials.gov