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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)

Primary Purpose

AML

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Clofarabine
Sponsored by
Nantes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for AML focused on measuring AML, primary induction failure

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Bordeaux
  • CHU Caen
  • CHRU lille
  • Hôpital Edouard Herriot
  • Institut Paoli Calmette
  • Nantes University hospital
  • Paris saint Louis
  • CHRU de Strasbourg
  • CHU Toulouse

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Clofarabine

Arm Description

Outcomes

Primary Outcome Measures

Evaluation of the survival rate at 2 years after transplantation

Secondary Outcome Measures

Full Information

First Posted
August 11, 2010
Last Updated
December 4, 2014
Sponsor
Nantes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01188174
Brief Title
Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
Acronym
setric
Official Title
Clofarabine/Ara-C Treatment Combined With Reduced-intensity Conditioning Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia in Primary Treatment Failure
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nantes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
AML
Keywords
AML, primary induction failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Clofarabine
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Clofarabine
Intervention Description
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 Measure Information:
Title
Evaluation of the survival rate at 2 years after transplantation
Time Frame
at 2 years after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamad Mohty, Phd
Organizational Affiliation
Nantes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU Caen
City
Caen
Country
France
Facility Name
CHRU lille
City
Lille
Country
France
Facility Name
Hôpital Edouard Herriot
City
Lyon
Country
France
Facility Name
Institut Paoli Calmette
City
Marseille
Country
France
Facility Name
Nantes University hospital
City
Nantes
ZIP/Postal Code
44200
Country
France
Facility Name
Paris saint Louis
City
Paris
Country
France
Facility Name
CHRU de Strasbourg
City
Strasbourg
Country
France
Facility Name
CHU Toulouse
City
Toulouse
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
27561720
Citation
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.
Results Reference
derived

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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

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