NCT03235973

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 29 (estimated)
• Sponsor: Institut Paoli-Calmettes · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Leukemia, Myeloid, Acute
• Leukemia, Lymphoblastic, Acute

Interventions

Type	Name	Description
DRUG	Fludarabine-Cladribine-Busulfan conditioning regimen	Conditioning regimen will be performed from day -6 to day -2 and contains: * Fludarabine 10 mg/m²/d during 5 days (day-6 to day-2). * Cladribine during 5 days (day-6 to day-2) at one the following define dose level: * Dose 1: 10 mg/m²/d * Dose 2: 15 mg/m²/d * Dose 3: 20 mg/m²/d * Dose 4: 25 mg/m²/d * IV busulfan will be given on day-6 using fixed dose as following: * If age ≤ 60 years: starting dose of 130 mg/m² * If age \> 60 years: starting dose of 100 mg/m² No busulfan will be administered at day-5, allowing the pharmacokinetic (PK) analyses . Subsequent infusion of IV busulfan will be performed from day-4 to day-2 at the dose recommended by PK analyses

Timeline

• Start date: 2018-04-28
• Primary completion: 2020-04-01
• Completion: 2021-04-01
• First posted: 2017-08-01
• Last updated: 2018-06-28

Locations

1 site across 1 country: France