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


Phase 2
18 Years
65 Years
Not Enrolling
Both
Hematological Malignancies

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

12 months after transplantation

Safety Issue:

Yes

Principal Investigator

Mohamad Mohty, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Nantes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 08/9-P

NCT ID:

NCT00841724

Start Date:

January 2009

Completion Date:

January 2012

Related Keywords:

  • Hematological Malignancies
  • Allogeneic stem cell transplantation
  • Reduced-intensity conditioning
  • Reduced-toxicity conditioning
  • Hematological malignancies
  • IV Busulfan
  • Neoplasms
  • Hematologic Neoplasms

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