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

NCT04451200 | Not Yet Recruiting Phase 2

• 1 other identifier: BUSEQ-IPC 2020-006
• Study Type: interventional
• Target: 82
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Leukemia; Mielodysplasic Syndrome; Myeloproliferative Neoplasm

Outcome Measures

Primary Outcomes (1)

• non-relapse mortality evaluation

  non-relapse mortality evaluation

  100 days post graft

Secondary Outcomes (14)

• incidence of grade 3 or 4 toxicities

  1 month

• graft taking after sequential busulfan conditioning

  day 30 and day 100 post graft

• incidence of transfusion needs for red blood cells

  day 30 post graft

• incidence of transfusion needs for red blood cells

  day 60 post graft

• incidence in graft taking after sequential busulfan conditioning

  day 100 post graft

Study Arms (1)

busulfan treatment

EXPERIMENTAL

Personalized BU administration

Drug: Busulfan Injection

Interventions

Busulfan Injection DRUG

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

busulfan treatment

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

MeSH Terms

Conditions

Myeloproliferative Disorders

Interventions

Busulfan

Condition Hierarchy (Ancestors)

Bone Marrow Diseases; Hematologic Diseases; 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

Central Study Contacts

Dominique Genre, MD

CONTACT

+33491223778; drci.up@ipc.unicancer.fr

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 3, 2020
• First Posted: June 30, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2023
• Study Completion (Estimated): December 1, 2028
• Last Updated: November 17, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share