Clinical trial · Interventional
Cladribine Dose Escalation in Conditioning Regimen Prior to Allo-HSCT for Refractory Acute Leukemia and Myelodysplastic Syndromes
NCT03235973CI-TRIAL-00033503CEREALunknownPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine-Cladribine-Busulfan conditioning regimen | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Fludarabine-Cladribine-Busulfan conditioning regimen
- interventionNames
- Drug: Fludarabine-Cladribine-Busulfan conditioning regimen
Primary outcomes (1)
- measure
- estimation of the maximal tolerable dose,if any,and recommended phase II dose of cladribine administered as in combination with fludarabine and PK-guided IV busulfan prior Allo-HSCT for refractory acute leukemia and myelodysplastic syndrome (MDS)
- timeFrame
- 30 days after Allo-HSCT
- description
- Occurrence ratio of dose-limiting toxicity defined as any grade ≥ 3 toxicity according to CTCAE (version 4.03 ) attributable to conditioning regimen (extra-medullary toxicity), considered to be related or probably related to the Cla-Fu-Bu RTC by the investigator.
Secondary outcomes (4)
- measure
- Cumulative incidence of acute Graft versus host disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.