Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

COMPLETED

The CLARA Study From the Acute Leukemia French Association (ALFA 0702 Trial)

Lead Sponsor:

Hospices Civils de Lyon

Conditions:

Acute Myeloid Leukemia

Eligibility:

All Genders

18-60 years

Phase:

PHASE2

Brief Summary

This study is a phase II randomized multicenter study. Patients will be enrolled at time of diagnosis and will receive one or two cycles of induction chemotherapy. Patients, without indication of inte...

Detailed Description

Because of the results of our former trial (ALFA-9802) \[Thomas, 2005\], chemotherapy will be combined in each arm with G-CSF (Granulocyte Colony-Stimulating Factor) given during each sequence of chem...

Eligibility Criteria

Inclusion

  • Inclusion Criteria at registration:
  • Age 18 years or more and less than 60 years
  • With:
  • A morphologically proven diagnosis of AML according to the WHO classification, cytogenetically (standard karyotype, FISH-MLL) and molecularly (FLT3, CEBPA, NMP1) defined.
  • ECOG (Eastern Cooperative Oncology Group) performance status 0 to 2.
  • Have adequate renal and hepatic function as indicated by the following laboratory values:
  • Creatinine clearance (calculated by the cockcroft and Gault method) ≥ 40mL/min;
  • AST (Aspartate amino transférase) and ALT (Alanine Amino Transférase ) \< or = 2.5N; total bilirubin \< or = 2N (unless related to the underlying disease).
  • Cardiac function determined by radionuclide or echography within normal limits.
  • Women of child-bearing potential (i.e. women who are pre-menopausal or not surgically sterile) must use acceptable contraceptive methods, and must have a negative serum or urine pregnancy test within 2 weeks prior the beginning treatment on this trial.
  • Must be able and willing to give written informed consent.
  • The subject must be covered by a social security system.
  • Exclusion Criteria at registration:
  • Patients with AML with favorable risk cytogenetics: M3-AML; CBF-AML including t(8:21), inv(16), or t(16;16) AML.
  • Ph-positive AML.
  • AML following diagnosed myeloproliferation or patient with prior history of MDS known for more than 3 months
  • Prior treatment with chemotherapy or radiotherapy for another tumor.
  • Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
  • Compromised organ function judged to be lifethreatening by the Investigator.
  • Positive serology for HIV (Human Immunodeficiency Virus), HBV (Hepatitis B Virus) and HBC (Hepatitis C Virus)(except post vaccination)
  • Uncontrolled active infection of any kind or bleeding. Patients with infections who are under active treatment with antibiotics and whose infections are controlled may be entered to the study.
  • Other active malignancy.
  • Patients concurrently receiving any other standard or investigational treatment for their leukemia, with the exception of hydroxyurea.
  • INCLUSION CRITERIA AT RANDOMIZATION
  • Patients with either in first CR/CRp after the first induction course or in first CR/CRp after salvage therapy.
  • ECOG performance status 0 to 2.
  • AST and ALT \< or = 2.5N; total bilirubin \< or = 2N.
  • Creatinine clearance ≥40mL/min (calculated by the cockcroft and Gault method or by MDRD (see http://nephron.org/cgi-bin/MDRD\_GFR/cgi)
  • Patient without HLA identical donor.
  • EXCLUSION CRITERIA AT RANDOMIZATION
  • Patients belonging to the intermediate 1 risk group (CEBPA+ or NPM1+ without Flt3-ITD) in CR/CRp after the first induction course. These patients will go out of the study and receive consolidation cycles based on HD-AraC (Aracytine).
  • Known central nervous system involvement with AML.
  • Uncontrolled active infection of any kind or bleeding.
  • Compromized organ function judged to be lifethreatening by the Investigator.
  • Patient with HLA identical donor identified.

Exclusion

    Key Trial Info

    Start Date :

    March 1 2009

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    April 1 2016

    Estimated Enrollment :

    735 Patients enrolled

    Trial Details

    Trial ID

    NCT00932412

    Start Date

    March 1 2009

    End Date

    April 1 2016

    Last Update

    September 3 2025

    Active Locations (34)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 9 (34 locations)

    1

    Hôpital Sud - CHU Amiens

    Amiens, France, 80054

    2

    Centre Hospitalier Regional et Universitaire d'Angers

    Angers, France, 49033

    3

    Hôpital Victor Dupouy

    Argenteuil, France, 95107

    4

    Hôpital Avicenne - bobigny

    Bobigny, France, 93009