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

Sponsor
Institut Paoli-Calmettes
Study ID
NCT04451200
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Acute Leukemia
  • Mielodysplasic Syndrome
  • Myeloproliferative Neoplasm

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Busulfan Injection — DRUG
    injections doses will be personalized by PK at days -7 and -4

Study Details

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.

Key Dates

First listed
Jun 30, 2020
Start date
Nov 30, 2020
Status verified
Oct 2020
Primary completion
Nov 30, 2023
Completion
Dec 31, 2028

Study Design

Enrollment
82 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: busulfan treatment
    Personalized BU administration

Primary Outcome Measure

non-relapse mortality evaluation [ Time Frame: 100 days post graft ]

Central Contacts

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