Sequential Conditioning in Haploidentical Transplantation for Refractory Acute Myeloid Leukemia

NACompletedINTERVENTIONAL
Enrollment

24

Participants

Timeline

Start Date

January 15, 2018

Primary Completion Date

December 18, 2021

Study Completion Date

December 18, 2021

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"

Trial Locations (1)

75012

Service d'hématologie Clinique Hôpital Saint Antoine, Paris

All Listed Sponsors
lead

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

OTHER

NCT03035422 - Sequential Conditioning in Haploidentical Transplantation for Refractory Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter