Clinical trial NCT00841724: Study of a Reduced-toxicity "Submyeloablative" Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Official title: Phase II Study of a Reduced-toxicity " Submyeloablative " Conditioning Regimen Prior to Allogeneic Stem Cell Transplantation in Patients With Hematological Malignancies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hematological Malignancies
Keywords: Allogeneic stem cell transplantation
Reduced-intensity conditioning
Reduced-toxicity conditioning
Hematological malignancies
IV Busulfan
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2009-02-11
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation
timeFrame: 12 months after transplantation
Secondary outcomes:
measure: 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
timeFrame: 12 months after transplantation
Other outcomes:
Locations:
city: Marseille
country: France
facility: Institut Paoli Calmettes
city: Nantes
country: France
facility: CHU de Nantes
city: Pessac
country: France
facility: CHU de Bordeaux
Study officials:
affiliation: Nantes University Hospital
name: Mohamad Mohty, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: