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

I

Institut Paoli-Calmettes

Status and phase

Unknown
Phase 1

Conditions

Leukemia, Lymphoblastic, Acute
Leukemia, Myeloid, Acute

Treatments

Drug: Fludarabine-Cladribine-Busulfan conditioning regimen

Study type

Interventional

Funder types

Other

Identifiers

NCT03235973
CEREAL-IPC 2016-010

Details and patient eligibility

About

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.

Enrollment

29 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

29 participants in 1 patient group

Fludarabine-Cladribine-Busulfan conditioning regimen
Experimental group
Treatment:
Drug: Fludarabine-Cladribine-Busulfan conditioning regimen

Trial contacts and locations

1

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Central trial contact

Dominique Genre, MD; Jihane Pakradouni, PharmD, PhD

Data sourced from clinicaltrials.gov

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