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CompletedNCT01188174setricUpdated Sep 14, 2026

Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure

A Phase 2 interventional study of Clofarabine in AML, sponsored by Nantes University Hospital. Completed at 9 sites in France. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-14.

Sponsored by Nantes University Hospital · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
26
Allocation
Not applicable
Ages
18 Years to 55 Years
Sex
All
01

Study summary

The present trial will establish a prospective sequential Allogeneic Stem Cell Transplantation (allo-SCT) treatment combining both salvage chemotherapy and Reduced Intensity Conditioning (RIC) for primary treatment failure Acute Myeloid Leukemia (AML), to which future innovative strategies can be compared.

Read the detailed description

Primary Endpoint: To improve the 2 year overall survival in patients with primary treatment failure

* Secondary Endpoints:

  • Feasibility of early transplantation within a multicenter trial
  • Leukemia-free survival (LFS) at 2 years from transplantation
  • Leukemia Response rate at day +30, +90 and 6 months
  • Cumulative incidence of relapse, death from leukemia, and non-relapse mortality (NRM)
  • Incidence and severity of acute and chronic Graft-versus-Host disease
  • Feasibility and safety of early discontinuation of immunosuppressive therapy
02

Conditions studied

  • AML

Keywords

  • AML
  • primary induction failure
03

In context

Lead sponsor

Nantes University Hospital is the lead sponsor of 825 studies on the registry; 195 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Confirmed diagnosis of AML in the status of primary induction failure (i.e. persistent leukemia after 2 courses of induction chemotherapy or persisting bone marrow hypoplasia fol-lowing induction chemotherapy +/-minimal residual disease)
  • Age: 18-55 years
  • Availability of an HLA identical family donor OR unrelated donor with matching in 10/10 alleles (HLA-A, B, C, DRB1, DQB1) or maximum of 1 allele or antigen mismatch OR family donor with maximum 1 allele mismatch.
  • Have adequate renal and hepatic functions as indicated by the following laboratory values:
  • Serum creatinine ≤1.0 mg/dL; if serum creatinine >1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be >60 mL/min/1.73 m² as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73 m2) = 186 x (Serum Creatinine)-1.154 x (age in years)-0.023 x (0.742 if patient is female)
  • Serum bilirubin ≤1.5 mg/dL × upper limit of normal (ULN)
  • Aspartate transaminase (AST)/alanine transaminase (ALT) ≤2.5 × ULN
  • Alkaline phosphatase ≤2.5 × ULN

Exclusion criteria

Exclusion Criteria:

  • Documented chloroma
  • Patients having AML M3
  • Documented leukemic infiltration of CNS/cerebrospinal fluid
  • Karnofsky performance score below \< 60%
  • Acute or chronic heart failure
  • HIV infection, chronic viral hepatitis
  • Severe neurological or psychiatric disorders
  • Any circumstances that preclude the use of the drugs used within the protocol
  • Prior allogeneic or autologous stem cell transplantation
  • > 3 courses of prior chemotherapy
  • Denied informed consent
  • Pregnancy or denied of effective contraceptive method
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
26 participants (actual)

Study arms

  • Experimental
    Clofarabine

    Drug: Clofarabine

Interventions

  • DrugClofarabine

    The present protocol aims to test the strategy of an early Reduced Intensity Conditioning (RIC) allo-SCT; in combination with a sequential preparative regimen for allo-SCT (Clofarabine, Intermediate dose Ara-C chemotherapy, followed by RIC with Cyclophosphamide, IV Busulfan and ATG; and delayed prophylactic infusion of donor lymphocytes (DLI) will be able to improve the outcome of patients with primary treatment failure AML.

06

What researchers measure

Primary outcomes

  1. Evaluation of the survival rate at 2 years after transplantation

    Time frame: at 2 years after transplantation

07

Study locations

9 sites
  • CHU de Bordeaux
    Bordeaux, France
  • CHU Caen
    Caen, France
  • CHRU lille
    Lille, France
  • Hôpital Edouard Herriot
    Lyon, France
  • Institut Paoli Calmette
    Marseille, France
  • Nantes University hospital
    Nantes, 44200, France
  • Paris saint Louis
    Paris, France
  • CHRU de Strasbourg
    Strasbourg, France
  • CHU Toulouse
    Toulouse, France
08

References and documents

Publications

  • Mohty M, Malard F, Blaise D, Milpied N, Socie G, Huynh A, Reman O, Yakoub-Agha I, Furst S, Guillaume T, Tabrizi R, Vigouroux S, Peterlin P, El-Cheikh J, Moreau P, Labopin M, Chevallier P. Sequential regimen of clofarabine, cytosine arabinoside and reduced-intensity conditioned transplantation for primary refractory acute myeloid leukemia. Haematologica. 2017 Jan;102(1):184-191. doi: 10.3324/haematol.2016.150326. Epub 2016 Aug 25. PubMed 27561720 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01188174
Lead sponsor
Nantes University Hospital
Responsible party
Sponsor
First posted
Aug 25, 2010
Start date
Jul 2010
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Sep 14, 2026

Study contacts

Mohamad Mohty, Phd
principal investigator · Nantes University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2014. You cannot join it, but the record below documents what was studied.

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