Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00841724

Acronym

ITT 08-01

Enrollment

Registered

2009-02-11

Start date

2009-01-01

Completion date

2012-01-01

Last updated

2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hematological Malignancies

Keywords

Allogeneic stem cell transplantation, Reduced-intensity conditioning, Reduced-toxicity conditioning, Hematological malignancies, IV Busulfan

Brief summary

The goal of this prospective study is to assess the overall mortality (whether related to relapse/progression or toxicity - TRM-) at one year after allogeneic stem cell transplantation prepared by a so-called reduced-toxicity "submyeloablative" conditioning regimen in patients with hematological malignancies.

Interventions

DRUGFludarabine, Busulfan, Thymoglobuline

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Patients affiliated to a social security reimbursement system * Adults (men or women) aged between 18 and 65 years * Negative test for pregnancy * ECOG 0-1 or Karnofsky Index ≥ 70% * Availability of an HLA-identical sibling donor, or an HLA-matched unrelated donor (10/10 HLA compatibility in A, B, C, DRB1, DQB1 (a single allelic mismatch at the level of Cw can be accepted) * Life expectancy \> 6 months * Signed informed consent * Diagnosis of an hematological malignancy that is considered to be eligible for an allogeneic stem cell transplantation

Exclusion criteria

* Pregnant woman or not willing to take effective contraception * Classical contra-indications to the allogeneic stem cell transplantation procedure * Any contra-indication to the use of the drugs contained within the conditioning regimen according to the summary of product characteristics * Patients aged \< 50 years and deemed to be eligible for a "standard" or conventional myeloablative conditioning regimen * An HLA-matched sibling donor who has a contra-indication for stem cell mobilization and collection * History of uncontrolled psychiatric condition * Patients who have participated to another trial testing an experimental drug within one month prior to inclusion in this protocol.

Design outcomes

Primary

Measure	Time frame
Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation	12 months after transplantation

Secondary

Measure	Time frame
To assess the "classical" criteria (clinical and biological) associated with outcome after allogeneic stem cell transplantation. To evaluate the impact of the modified Charlson comorbidity score (Sorror Score) on TRM and 1-year overall survival	12 months after transplantation

Countries

France

Contacts

PRINCIPAL_INVESTIGATORMohamad Mohty, MD, PhD

Nantes University Hospital

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 15, 2026