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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 10, 2009

Last Updated Date

May 15, 2012

Start Date ^ICMJE

January 2009

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00841724 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

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

Condition ^ICMJE

Hematological Malignancies

Intervention ^ICMJE

Drug: Fludarabine, Busulfan, Thymoglobuline

Study Arm (s)

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

Intervention: Drug: Fludarabine, Busulfan, Thymoglobuline

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2012

Primary Completion Date

January 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT00841724

Other Study ID Numbers ^ICMJE

BRD 08/9-P

Has Data Monitoring Committee

Responsible Party

Anne Omnès, Nantes University Hospital

Study Sponsor ^ICMJE

Nantes University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Mohamad Mohty, MD, PhD

CHU Nantes

Information Provided By

Nantes University Hospital

Verification Date

May 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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