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.
Sponsor:
Information provided by:
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT00841724
First received: February 10, 2009
Last updated: May 15, 2012
Last verified: May 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00841724

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

No publications provided

Responsible Party: Anne Omnès, Nantes University Hospital
ClinicalTrials.gov Identifier: NCT00841724     History of Changes
Other Study ID Numbers: BRD 08/9-P
Study First Received: February 10, 2009
Last Updated: May 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

Additional relevant MeSH terms:
Neoplasms
Hematologic Neoplasms
Neoplasms by Site
Hematologic Diseases
Busulfan
Fludarabine monophosphate
Fludarabine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Myeloablative Agonists
Antimetabolites, Antineoplastic
Antimetabolites

ClinicalTrials.gov processed this record on July 24, 2014