Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes

• Status: Unknown status
• Trial end date: 2021-04-01
• Target enrollment: 0
• Participant gender: All

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 busulfan doses. This scheme allows combining different optimization of RTC experienced over years (Flu-Bu RTC, PK-guided myeloablative busulfan doses, a second purine analog cladribine) to approach a specific platform to treat refractory diseases.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut Paoli-Calmettes
• Treatments: Busulfan; Cladribine; Fludarabine; Fludarabine phosphate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.