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Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies (ITT 08-01)

This study has been completed.
Information provided by:
Nantes University Hospital Identifier:
First received: February 10, 2009
Last updated: May 15, 2012
Last verified: May 2012
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.

Condition Intervention Phase
Hematological Malignancies Drug: Fludarabine, Busulfan, Thymoglobuline Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies

Resource links provided by NLM:

Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation [ Time Frame: 12 months after transplantation ]

Secondary Outcome Measures:
  • 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 [ Time Frame: 12 months after transplantation ]

Enrollment: 82
Study Start Date: January 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Busilvex, Fludara, Thymoglobuline
D-6: Fludara D-5: Fludara + Busilvex D-4: Fludara + Busilvex D-3: Fludara + Busilvex D-2: Fludara + Thymoglobuline D-1: Thymoglobuline D0: graft infusion
Drug: Fludarabine, Busulfan, Thymoglobuline


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
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Please refer to this study by its identifier: NCT00841724

Institut Paoli Calmettes
Marseille, France, 13273
CHU de Nantes
Nantes, France, 44093
CHU de Bordeaux
Pessac, France, 33604
Sponsors and Collaborators
Nantes University Hospital
Principal Investigator: Mohamad Mohty, MD, PhD CHU Nantes
  More Information

Responsible Party: Anne Omnès, Nantes University Hospital Identifier: NCT00841724     History of Changes
Other Study ID Numbers: BRD 08/9-P
Study First Received: February 10, 2009
Last Updated: May 15, 2012

Keywords provided by Nantes University Hospital:
Allogeneic stem cell transplantation
Reduced-intensity conditioning
Reduced-toxicity conditioning
Hematological malignancies
IV Busulfan

Additional relevant MeSH terms:
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Myeloablative Agonists processed this record on September 21, 2017