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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


Phase 2
18 Years
55 Years
Open (Enrolling)
Both
AML

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Trial Information

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


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


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluation of the survival rate at 2 years after transplantation

Outcome Time Frame:

at 2 years after transplantation

Safety Issue:

Yes

Principal Investigator

Mohamad Mohty, Phd

Investigator Role:

Principal Investigator

Investigator Affiliation:

CHU Nantes

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

BRD 09/6-C

NCT ID:

NCT01188174

Start Date:

July 2010

Completion Date:

September 2014

Related Keywords:

  • AML
  • AML
  • primary induction failure
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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