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

January 22, 2019 updated by: Institut Paoli-Calmettes

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13009
        • Institut Paoli Calmettes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Busulfan with adapted doses
Conditioning regimen for allogeneic transplant (Busulfan, Thymoglobuline and Fludarabine)
Drug: Allogeneic transplant conditioning
Allogeneic transplant
Other Names:
  • Busulfan, thymoglobuline, fludarabine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
rates progression free survival 2 years
Time Frame: Time to progression or death
Time to progression or death

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasmatic concentration of Busulfan
Time Frame: Time from inclusion until Day -1 before allogenic transplantation
Time from inclusion until Day -1 before allogenic transplantation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Paoli-Calmettes

Collaborators

Agence de La Biomédecine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2014

Primary Completion (Actual)

March 1, 2018

Study Completion

March 1, 2020

Study Registration Dates

First Submitted

June 24, 2015

First Submitted That Met QC Criteria

June 25, 2015

First Posted (Estimate)

June 26, 2015

Study Record Updates

Last Update Posted (Actual)

January 24, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BX-PK-IPC 2013-016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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