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Sequential and Personalized PK-guided Busulfan Administration in the Frame of the Conditiong Regimen for Allo-HSCT in Patients With Malignant Hemopathies Ineligible for the Standard Myeloablative Conditioning

NCT ID: NCT04451200

Last Updated: 2020-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-30

Study Completion Date

2028-12-31

Brief Summary

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Because the anti-leukemic activity of busulfan, this dug is largely used in graft conditioning but in elderly and/or cormobid patienth an excess of toxicity is observed. This study focus on the possibility of significanty reducing this toxicity by customizing the doses of busulfan to individual PK parameters.

Detailed Description

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Conditions

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Acute Leukemia Mielodysplasic Syndrome Myeloproliferative Neoplasm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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busulfan treatment

Personalized BU administration

Group Type EXPERIMENTAL

Busulfan Injection

Intervention Type DRUG

injections doses will be personalized by PK at days -7 and -4

Interventions

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Busulfan Injection

injections doses will be personalized by PK at days -7 and -4

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patient up to 65 years old
* Acute leukemia, myelodysplastic syndrome or myeloproliferative neoplasia eligible for an allogeneic transplant
* Chemosensitive disease, in complete or partial or stable remission
* Allograft from an identical HLA related donor, Haplo-identical or unrelated (HLA compatibility from 8/10 to 10/10 according to HLA-A, -B, -C, -DR, -DQ allelics)
* Signed consent to participate

-. Affiliation to a social security regimen or beneficiary of this regimen
* Patient not eligible for standard myeloablative conditioning due to age\> = 45 years and / or the presence of an HCT-CI comorbidity score\> = 3

Exclusion Criteria

* Pregnant woman, without effective contraception or breastfeeding
* Person in emergency situation, patient deprived of liberty or placed under the authority of a tutor,
* Impossibility of undergoing medical follow-up of the trial for geographic, social or psychological reasons
* Contraindications to performing an allogeneic transplant
* Previous allograft
* Placental blood allograft
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institut Paoli-Calmettes

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Dominique Genre, MD

Role: CONTACT

Phone: +33491223778

Email: [email protected]

Other Identifiers

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BUSEQ-IPC 2020-006

Identifier Type: -

Identifier Source: org_study_id