CompletedPhase 3

Busulfan (BU) Plus Fludarabine Vs Intravenous BU Plus Cyclophosphamide as Conditioning Regimens Prior Allogeneic Hematopoetic Stem Cells Transplant (HSCT) in AML

Israel, Italy252 participantsStarted 2008-01

Plain-language summary

The purpose of this prospective phase III, open-label, randomized multicenter study is to evaluate whether Acute Myeloid Leukemia (AML) elderly patients in Complete Remission (CR) undergoing allogeneic hematopoietic stem cell transplantation after a reduce toxicity conditioning regimen (I.V. BuFlu) as compared to the conventional I.V. BuCy2 program will experience: 1. A lower transplant-related mortality (TRM) at 1 year after Hematopoietic Stem Cells Transplant (HSCT) 2. A similar anti-leukemic activity and a similar or better safety profile, in terms of: * Early and/or late graft rejection * Hematopoietic and immunologic recovery * Chimerism * Toxicity and incidence of Veno-occlusive Disease (VOD) * Acute (aGvHD) and chronic graft-versus-host disease (cGvHD) * Cumulative incidence of TRM at +100 days and 2 years after transplant * Cumulative incidence of relapse by 1 and 2 years after transplant * Event-free (EFS) and overall survival (OS) by 1 and 2 years after transplant

Who can participate

Age range40 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients * Age more than 40 and less than 65 years * Diagnosis of AML (FAB or WHO classification) in Complete Remission (CR) * Availability of an HLA compatible sibling or unrelated donor * Performance status : Eastern Cooperative Oncology Group (ECOG)\<3 * Written and signed informed consent * Central Venous access (Central KT) secured through an indwelling catheter. * Life expectancy not severely limited by concomitant illness. Donors * Age between 18 years and 65 years inclusive. * Availability of an HLA-identical sibling donor (MRD) or HLA-compatible unrelated donor (MUD). Donor selection is based on molecular high-resolution typing (4 digits) of the HLA gene loci class I (HLA- A, B, and C) and class II (DRB1). In case, no class I and class II completely identical donor (8 out of 8 gene loci) can be identified, one antigen/allele disparity (class I) or one allele disparity (class II, DRB1) between patient and donor are acceptable. In any cases the degree of histocompatibility between patient and donor must fulfill with the minimal degree of matching established by the Italian Bone Marrow Donor Registry. Exclusion Criteria: Patients * AML patients in 1st CR with: * t(15;17) or promyelocytic leukemia/retinoic acid receptor gene translocation, PML/RARα positive APL * t(8;21)(q22;q22) with white blood cells (WBC) count at diagnosis less than 20 x 109/L without additional adverse cytogenetic abnormalities. * inv(16) or t(16;16)(p13;q22) without…

What they're measuring

transplant-related mortality (TRM)

Timeframe: 1 year post transplant

Trial details

NCT IDNCT01191957

SponsorGruppo Italiano Trapianto di Midollo Osseo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2012-12