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

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ClinicalTrials.gov Identifier: NCT01188174
Recruitment Status : Completed
First Posted : August 25, 2010
Last Update Posted : December 5, 2014
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
AML Drug: Clofarabine Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
Study Start Date : July 2010
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014


Arm Intervention/treatment
Experimental: Clofarabine Drug: 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.




Primary Outcome Measures :
  1. Evaluation of the survival rate at 2 years after transplantation [ Time Frame: at 2 years after transplantation ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188174


Locations
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France
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, 44200
Paris saint Louis
Paris, France
CHRU de Strasbourg
Strasbourg, France
CHU Toulouse
Toulouse, France
Sponsors and Collaborators
Nantes University Hospital
Investigators
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Principal Investigator: Mohamad Mohty, Phd CHU Nantes

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01188174    
Other Study ID Numbers: BRD 09/6-C
First Posted: August 25, 2010    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014
Keywords provided by Nantes University Hospital:
AML
primary induction failure
Additional relevant MeSH terms:
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Leukemia, Myeloid, Acute
Leukemia
Neoplasms by Histologic Type
Neoplasms
Leukemia, Myeloid
Clofarabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents