Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
NCT ID: NCT01188174
Last Updated: 2014-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
26 participants
INTERVENTIONAL
2010-07-31
2014-12-31
Brief Summary
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Detailed Description
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\* 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
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Clofarabine
Clofarabine
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.
Interventions
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Clofarabine
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Nantes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Mohamad Mohty, Phd
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
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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, , France
Paris saint Louis
Paris, , France
CHRU de Strasbourg
Strasbourg, , France
CHU Toulouse
Toulouse, , France
Countries
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References
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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.
Other Identifiers
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BRD 09/6-C
Identifier Type: -
Identifier Source: org_study_id