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Completed

NCT Number: NCT02483325

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.

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Key information

Conditions

Hematological Diseases Hematologic Diseases Hemic and Lymphatic Diseases

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Institut Paoli Calmettes

Marseille, 13009, France

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Allogeneic transplant conditioning

Drug

Allogeneic transplant

Other names: Busulfan, thymoglobuline, fludarabine

Primary outcomes

  1. rates progression free survival 2 years

    Time frame: Time to progression or death

Secondary outcomes

  1. Plasmatic concentration of Busulfan

    Time frame: Time from inclusion until Day -1 before allogenic transplantation

Sponsors and collaborators

Lead sponsor

Institut Paoli-Calmettes

Other

Collaborators

  • Agence de La Biomédecine

Registry information

Official study 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

Acronym: BX-PK

Important dates

Study start
2014
Primary completion
2018
Study completion
2020
First posted
Jun 26, 2015
Registry last updated
Jan 24, 2019

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.

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