Allogeneic Hematopoietic Cell Transplantation From HLA-matched Donor After Flu-Mel-PTCy Versus Flu-Mel-ATG Reduced-intensity Conditioning

ConditionsAcute Myeloid Leukemia in Remission Myelodysplastic Syndromes Chronic Myeloid Leukemia in Remission Myeloproliferative Syndrome Myeloproliferative Disorder Acute Lymphoid Leukemia in Remission Multiple Myeloma Chronic Lymphoid Leukemia Non Hodgkin Lymphoma Hodgkin Lymphoma

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorUniversity of Liege

About this trial

The present project aims at comparing two conditioning regimens (FM-PTCy vs FM-ATG). The hypothesis is that one or the two regimens will lead to a 2-year cGRFS rate improvement from 30% (the cGRFS rate with FM without ATG/PTCy) to 45% (Pick-a-winner phase 2 randomized study).

Eligibility criteria

Qualifiers

AML in morphological CR or not in morphological CR but not rapidly progressing (i.e. no need to give treatments such as hydroxyurea to maintain WBC count < 10 000 x109/mL);

MDS;

CML in CP or AP;

MPD not in blast crisis,

Disqualifiers

Any condition not fulfilling inclusion criteria;

Human Immunodeficiency Virus positive;

Non-hematological malignancy(ies) (except non-melanoma skin cancer) active < 3 years before Hematopoietic Cell Transplantation (HCT).

Life expectancy severely limited by disease other than malignancy;

Trial design

Treatments tested in this trial

Thymoglobulin
Melphalan
Fludarabine
Cyclophosphamid

Treatment groups

114 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of Liege

Lead sponsor

Belgian Hematological Society

Collaborator

Source ClinicalTrials.gov