Elderly Patients With Acute Myeloid Leukemia (AML), Maintenance Phase After Complete Remission (CR)

Acute Myeloid Leukemia Clinical Trial

Official title:

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 Fit Patients With Poor Prognosis Acute Myeloid Leukemia.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01301820
• Other study ID #: LAMSA-maintenance Rev-5Aza
• Status: Completed
• Phase: Phase 2
• First received: February 4, 2011
• Last updated: March 15, 2016
• Start date: January 2011
• Est. completion date: February 2013

Study information

• Verified date: March 2016
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Phase II Multicentric Trial Open Label, Multicenter, randomized to evaluate the efficacy of a Maintenance Therapy in First Complete Remission After Induction for Elderly (≥ 60) Fit Patients With Poor Prognosis Acute Myeloid Leukemia (AML).

The disease-free survival (DFS) of the patients included in this study will be compared to the ones of the two previously reported groups of patients treated with the same LIA induction therapy

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

• 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• azacitidine
azacitidine sc 75 mg/m²/d (d1- d7)
• Lenalidomide
lenalidomide 10mg/d (d1- d21)

Locations

Country	Name	City	State
France	Mathilde HUNAULT BERGER	Angers

Sponsors (2)

Lead Sponsor	Collaborator
French Innovative Leukemia Organisation	Celgene Corporation

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DFS	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.	18 months	No
Secondary	relapse incidence OS EFS Infectious events	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.	until death	No
Secondary	gene expression and promoter methylation signatures associated with CR	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.	0	No

External Links

•   FILO Website