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

Hematological Malignancies Clinical Trial

— ITT 08-01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00841724
• Other study ID #: BRD 08/9-P
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2009
• Last updated: May 15, 2012
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: Nantes University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Hematological Malignancies
• Neoplasms

Intervention

Drug:
• Fludarabine, Busulfan, Thymoglobuline

Locations

Country	Name	City	State
France	Institut Paoli Calmettes	Marseille
France	CHU de Nantes	Nantes
France	CHU de Bordeaux	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of the overall mortality rate at 12 months after allogeneic stem cell transplantation		12 months after transplantation	Yes
Secondary	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		12 months after transplantation	Yes