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

NCT01191957 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2023-03-10

No results posted yet for this study

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

Conditions

  • Acute Myeloid Leukemia (AML)

Interventions

DRUG

Busulphan plus Cyclophosphamide

I.V. Bu (Busilvex), 12.8 mg/kg: Day -9: 0.8 mg/kg/dose x 4 doses Day -8: 0.8 mg/kg/dose x 4 doses Day -7: 0.8 mg/kg/dose x 4 doses Day -6: 0.8 mg/kg/dose x 4 doses Day -5: Rest Followed by: Cyclophosphamide, 120 mg/kg iv: Day -4: 60 mg/kg Day -3: 60 mg/kg

DRUG

Busulphan plus Fludarabine

I.V. Bu (Busilvex), 12.8 mg/kg: Day -6: 0.8 mg/kg/dose x 4 doses Day -5: 0.8 mg/kg/dose x 4 doses Day -4: 0.8 mg/kg/dose x 4 doses Day -3: 0.8 mg/kg/dose x 4 doses plus: Fludarabine, 4 x 40 mg/m² iv: Day -6: 40 mg/m² Day -5: 40 mg/m² Day -4: 40 mg/m² Day -3: 40 mg/m²

Sponsors & Collaborators

  • Gruppo Italiano Trapianto di Midollo Osseo

    lead OTHER

Principal Investigators

  • Alessandro AR Rambaldi, Professor · A.O. Papa Giovanni XXIII

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2012-12-31
Completion
2014-10-31

Countries

  • Israel
  • Italy

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 NCT01191957 on ClinicalTrials.gov