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

NCT02483325 | Completed Phase 2

• 1 other identifier: BX-PK-IPC 2013-016
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

Determine the efficiency of a myéloablative 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.

Conditions

Hematological Diseases

Outcome Measures

Primary Outcomes (1)

• rates progression free survival 2 years

  Time to progression or death

Secondary Outcomes (1)

• Plasmatic concentration of Busulfan

  Time from inclusion until Day -1 before allogenic transplantation

Study Arms (1)

Busulfan with adapted doses

OTHER

Conditioning regimen for allogeneic transplant (Busulfan, Thymoglobuline and Fludarabine)

Drug: Allogeneic transplant conditioning

Interventions

Allogeneic transplant conditioning DRUG

Allogeneic transplant

Also known as: Busulfan, thymoglobuline, fludarabine

Busulfan with adapted doses

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead
• Agence de La Biomédecine: collaborator

Study Sites (1)

Institut Paoli Calmettes

Marseille, 13009, France

Location

Related Links

• official web site of the sponsor

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Busulfan; Antilymphocyte Serum; fludarabine

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Immune Sera; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: June 26, 2015
• Study Start: September 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2020
• Last Updated: January 24, 2019

Record last verified: 2019-01

Locations

FR (1)