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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)

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ClinicalTrials.gov Identifier: NCT00841724
Recruitment Status : Completed
First Posted : February 11, 2009
Last Update Posted : May 16, 2012
Information provided by:
Nantes University Hospital

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.

Condition or disease Intervention/treatment Phase
Hematological Malignancies Drug: Fludarabine, Busulfan, Thymoglobuline Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
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
Study Start Date : January 2009
Primary Completion Date : January 2012
Study Completion Date : January 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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

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

Secondary Outcome Measures :
  1. 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 ]

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Anne Omnès, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00841724     History of Changes
Other Study ID Numbers: BRD 08/9-P
First Posted: February 11, 2009    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 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:
Antilymphocyte Serum
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Myeloablative Agonists