Busulfan (BU) Plus Fludarabine Vs Intravenous BU Plus Cyclophosphamide as Conditioning Regimens P… (NCT01191957) | Clinical Trial Compass
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 range
40 Years – 65 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.