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Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex®) in Patients at High Risk of Carrying Blood Diseases

Information source: Institut Paoli-Calmettes
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hematological Diseases

Intervention: Allogeneic transplant conditioning (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Institut Paoli-Calmettes

Overall contact:
Dominique GENRE, MD, Phone: 33 (0)4 91 22 37 78, Email: drci.up@ipc.unicancer.fr

Summary

Determine the efficiency of a myloablative conditioning associating Fludarabine, Thymoglobuline, and intravenous Busulfan with adapted dose, according to a pharmacokinetics realized in the first day of administration (or J-6 of the conditioning) of the busulfan, in preparation for a allogenic transplant family or not family compatible HLA.

Clinical Details

Official title: Phase II Study Evaluating the Efficacy of Allogeneic Transplant Conditioning With Adaptive Dose Busulfan Intravenous (Busilvex) in Patients at High Risk of Carrying Blood Diseases

Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: rates progression free survival 2 years

Secondary outcome: Plasmatic concentration of Busulfan

Eligibility

Minimum age: 55 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria :

- Informed consent signed,

- Patient affiliated to a social security system or benefiting from such a system,

- Related HLA identical donor or unrelated HLA identical donor :

all patients aged > 55 years with hematological malignancy and deemed eligible for an allogeneic transplant from a geno-identical donor and pheno-identical 10/10

- the basic pathology should be considered "chemo-sensitive" complete or partial remission

(CR, PR) or stable disease Exclusion Criteria :

- Pregnant or lactating woman or without contraception (for child bearing potential

women)

- Patient deprived of liberty or under supervision of a guardian

- Impossibility to undergo medical examinations of the study for geographical, social

or psychological reasons

- Usual contra-indications for allogenic transplant

- Aged < 55 years

- History of allogenic transplant

- Concomitant neoplastic disease

- Evolutive psychiatric disease

- HIV seropositivity or C hepatitis under treatment

- Women of childbearing age or man, in the absence of effective contraception during

treatment and up to 12 months after treatment discontinuation

Locations and Contacts

Dominique GENRE, MD, Phone: 33 (0)4 91 22 37 78, Email: drci.up@ipc.unicancer.fr

Institut Paoli Calmettes, Marseille 13009, France; Recruiting
FURST Sabine, MD, Principal Investigator
Additional Information

official web site of the sponsor

Starting date: September 2014
Last updated: June 26, 2015

Page last updated: August 23, 2015

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