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

NCT ID: NCT01301820

Last Updated: 2016-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2013-02-28

Brief 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

Detailed 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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ARM A

maintenance study treatment: azacitidine sc 75 mg/m²/d (d1- d7) in first cycle: months 1,3,5,7,9 ,11 then lenalidomide 10mg/d (d1- d21) months 2,4,6,8,10,12

Group Type: OTHER

azacitidine

Intervention Type: DRUG

azacitidine sc 75 mg/m²/d (d1- d7)

ARM B

maintenance study treatment: lenalidomide 10mg/d (d1- d21)in first cycle and months 1,3,5,7,9 ,11 then azacitidine sc 75 mg/m²/d (d1- d7) months 2,4,6,8,10,12

Group Type: OTHER

Lenalidomide

Intervention Type: DRUG

lenalidomide 10mg/d (d1- d21)

Interventions

azacitidine

azacitidine sc 75 mg/m²/d (d1- d7)

Intervention Type: DRUG

Lenalidomide

lenalidomide 10mg/d (d1- d21)

Intervention Type: DRUG

Other Intervention Names

vidaza®; revlimid®

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Celgene Corporation

INDUSTRY

Sponsor Role: collaborator

French Innovative Leukemia Organisation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mathilde HUNAULT BERGER, MD PD

Role: PRINCIPAL_INVESTIGATOR

French Innovative Leukemia Organisation

Locations

Mathilde HUNAULT BERGER

Angers, , France

Countries

France

Related Links

http://www.filo-leucemie.org

FILO Website

Other Identifiers

LAMSA-maintenance Rev-5Aza

Identifier Type: -

Identifier Source: org_study_id