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

NCT01301820 | Completed Phase 2 DMC

• 1 other identifier: LAMSA-maintenance Rev-5Aza
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Myeloid Leukemia

Keywords

maintenance treatment; Disease free survival

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

• relapse incidence OS EFS Infectious events

  until death

• gene expression and promoter methylation signatures associated with CR

  0

Study Arms (2)

ARM A

OTHER

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

Drug: azacitidine

ARM B

OTHER

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

Drug: Lenalidomide

Interventions

azacitidine DRUG

azacitidine sc 75 mg/m²/d (d1- d7)

Also known as: vidaza®

ARM A

Lenalidomide DRUG

lenalidomide 10mg/d (d1- d21)

Also known as: revlimid®

ARM B

Eligibility Criteria

• Age: 60 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French Innovative Leukemia Organisation: lead
• Celgene Corporation: collaborator

Study Sites (1)

Mathilde HUNAULT BERGER

Angers, 49033, France

Location

Related Links

• FILO Website

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Azacitidine; Lenalidomide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides; Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Piperidones; Piperidines; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Mathilde HUNAULT BERGER, MD PD

  French Innovative Leukemia Organisation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2011
• First Posted: February 23, 2011
• Study Start: January 1, 2011
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: March 16, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)