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

Information source: Nantes University Hospital
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hematological Malignancies

Intervention: Fludarabine, Busulfan, Thymoglobuline (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Nantes University Hospital

Official(s) and/or principal investigator(s):
Mohamad Mohty, MD, PhD, Principal Investigator, Affiliation: CHU Nantes

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.

Clinical Details

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

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

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

Secondary outcome: 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

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Institut Paoli Calmettes, Marseille 13273, France

CHU de Nantes, Nantes 44093, France

CHU de Bordeaux, Pessac 33604, France

Additional Information

Starting date: January 2009
Last updated: May 15, 2012

Page last updated: August 23, 2015

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