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

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.

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Key information

Conditions

Hematological Malignancies Hematologic Diseases Hematologic Neoplasms Hemic and Lymphatic Diseases Neoplasms Neoplasms by Site

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Paoli Calmettes, Marseille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fludarabine, Busulfan, Thymoglobuline

Drug

Primary outcomes

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

Time frame: 12 months after transplantation

Secondary outcomes

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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study title

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

Acronym: ITT 08-01

Important dates

Study start: 2009
Primary completion: 2012
Study completion: 2012
First posted: Feb 11, 2009
Registry last updated: May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed