AMLPhase 2setricNCT01188174
Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
A Phase 2 study testing Clofarabine in people with AML, run by Nantes University Hospital at 9 sites in France.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- AML
- What is being tested?
- Clofarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 9 sitesFrance
- Study dates
- Jul 2010to Dec 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
France9 sites
CHU de Bordeaux
Bordeaux
CHU Caen
Caen
CHRU lille
Lille
Hôpital Edouard Herriot
Lyon
Institut Paoli Calmette
Marseille
Nantes University hospital
Nantes, 44200
Paris saint Louis
Paris
CHRU de Strasbourg
Strasbourg
CHU Toulouse
Toulouse
About this study
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
- Conditions
- AML
- Being tested
- Clofarabine
- Keywords
- AML, primary induction failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ClofarabineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Clofarabine | Experimental | Not described Receives: Drug: Clofarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the survival rate at 2 years after transplantation
Measured: at 2 years after transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2010 (estimated)
- Study startJul 2010
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AMLStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamad Mohty, Phd, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01188174
- Sponsor's protocol ID
- BRD/09/06-C
- Acronym
- setric
- Status last verified
- Dec 2014
- First submitted
- 11 Aug 2010
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
- ClinicalTrials.gov ID
- NCT01188174
- Acronym / sponsor ID
- setric / BRD/09/06-C
- Conditions
- AML
- Keywords
- AML, primary induction failure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 25 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clofarabine | Experimental | Drug: Clofarabine |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (12 listed)
- Documented chloroma
- Patients having AML M3
- Documented leukemic infiltration of CNS/cerebrospinal fluid
- Karnofsky performance score below < 60%
- Acute or chronic heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ClofarabineThe 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. | Drug | Clofarabine |
Primary outcome
Evaluation of the survival rate at 2 years after transplantation
Time frame: at 2 years after transplantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Results publication: PubMed 27561720Mohty 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamad Mohty, Phd principal investigator
Nantes University Hospital
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Clofarabine in people with AML, run by Nantes University Hospital at 9 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the survival rate at 2 years after transplantation (time frame: at 2 years after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01188174, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.