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Phase II Multicentric Trial Maintenance Therapy With 6 Monthly Revlimid® Cycles Alternated With 6 Monthly Vidaza® Cycles in First CR After Induction LIA Chemotherapy for Elderly (≥ 60) Fit Patients With Poor Prognosis Acute Myeloid Leukemia.


Phase 2
60 Years
75 Years
Not Enrolling
Both
Acute Myeloid Leukemia

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Trial Information

Phase II Multicentric Trial Maintenance Therapy With 6 Monthly Revlimid® Cycles Alternated With 6 Monthly Vidaza® Cycles in First CR After Induction LIA Chemotherapy for Elderly (≥ 60) Fit Patients With Poor Prognosis Acute Myeloid Leukemia.


- The primary objective of this study will be to improve the DFS with an alternate schema
combining azacitidine and lenalidomide in elderly fit patients with previously
untreated AML and with high risk cytogenetics or secondary AML, who achieved either a
complete remission after an LIA induction therapy

- The secondary objectives will be to determine the relapse incidence, overall survival,
event free survival at 1 and 2 years of follow-up, toxicities of the treatment,
incidence of infectious events.

- To define a gene expression and promoter methylation signatures associated with CR and
absence of relapse when patients received azacitidine and lenalidomide. Gene promoter
methylation and gene expression profiling will be performed at diagnosis, at CR, and
after 2 courses of azacitidine and lenalidomide in order to give insight within the
mechanisms involved by the use of these 2 drugs and to identify new epigenetic
prognostic markers.


Inclusion Criteria:



- Cytologically or histologically confirmed acute myeloid leukemia (AML) with :

- At least 60 years of age and fit for intensive chemotherapy: PS <2 (ECOG)

- Absence of significant co-morbidities

- Less than 75 years* of age

- LAM with high risk features (blasts > 20% in bone marrow)

- Poor risk cytogenetics

- Life expectancy > 1 month

- Affiliated to social security regimen

- No granulocytic sarcoma as sole site of disease

- Able and willing to provide written and signed informed consent

Exclusion Criteria:

- Total bilirubin > 2 times upper limit of normal

- AST and ALT and/or alkaline phosphatase > 4 times upper limit of normal if not in
relation with AML.

- Factor V < 50% without DIC (Disseminated Intravascular Coagulation)

- NYHA class III or IV congestive heart failure (Echo < 40%, LVEF < 50%),Unstable
angina pectoris, Serious cardiac arrhythmia

- Renal failure not related to AML: serum creatinin > 170 μmol/L or clearance of
creatinin ≤ 50 mL/mn

- Known HIV 1- HIV 2 positivity

- Prior therapy with azacitidine or lenalidomide

- Psychiatric illness or social situations that would preclude compliance with study
requirements

- Uncontrolled infection

- Urgent chemotherapy for DIC, spontaneous tumoral lyse syndrome, leucostase without
cytogentic results

- Women who are pregnant or breastfeeding

- Women who are unwilling or unable to use an acceptable contraceptive method to avoid
pregnancy

- Men who are unwilling or unable to use an acceptable method of birth control

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

DFS

Outcome Description:

The primary objective of this study will be to improve the DFS with an alternate schema combining azacitidine and lenalidomide in elderly fit patients with previously untreated AML and with high risk cytogenetics or secondary AML, who achieved either a complete remission after an LIA induction therapy.

Outcome Time Frame:

18 months

Safety Issue:

No

Principal Investigator

Mathilde HUNAULT BERGER, MD PD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS

Authority:

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

Study ID:

LAMSA-maintenance Rev-5Aza

NCT ID:

NCT01301820

Start Date:

January 2011

Completion Date:

February 2013

Related Keywords:

  • Acute Myeloid Leukemia
  • maintenance treatment
  • Disease free survival
  • Leukemia
  • Leukemia, Myeloid, Acute
  • Leukemia, Myeloid

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