Status:
UNKNOWN
Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Leukemia, Myeloid, Acute
Leukemia, Lymphoblastic, Acute
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The investigators focused on patients with refractory acute leukemia or MDS and designed a phase 1 trial of escalated cladribine doses in the Cla-Flu-Bu RTC regimen using PK-guided myeloablative busul...
Eligibility Criteria
Inclusion
- Age 18-70
- ECOG 0 or 1
- Acute leukemia (AML or ALL) without criteria for CR or high risk MDS without criteria for CR
- Availability of a donor among following oHLA identical sibling oHaploidentical donor o10/10 or 9/10 allele-level HLA matched unrelated donor
- Signed informed consent
- Patient affiliated to the national "Social Security" regimen or beneficiary of this regimen
Exclusion
- Contraindication for Allo-HSCT
- Cord blood Allo-HSCT
- Current active disease or positive serology for HIV, and/or HCV with detectable viremia and/ or HBV with positive Hbs Antigen.
- Renal failure with creatinine clearance \< 30 ml/ min
- Decompensated haemolytic anaemia
- Hypersensitivity to an active substance or to any of the excipients
- Acute urinary infection
- Pre-existing haemorrhagic cystitis
- Woman of childbearing potential not using an effective contraception .
- Pregnant or lactating women
- Any serious concurrent uncontrolled medical disorder
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule.
Key Trial Info
Start Date :
April 28 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2021
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT03235973
Start Date
April 28 2018
End Date
April 1 2021
Last Update
June 28 2018
Active Locations (1)
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1
Institut Paoli-Calmettes
Marseille, Bouches-du-Rhône, France, 13009