Back to results

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

Primary Purpose

Acute Myeloid Leukemia

Status

Completed

Phase

Phase 2

Locations

France

Study Type

Interventional

Intervention

azacitidine

Lenalidomide

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring maintenance treatment, Disease free survival

Eligibility Criteria

60 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Mathilde HUNAULT BERGER

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

ARM A

ARM B

Arm Description

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

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

Outcomes

Primary Outcome Measures

DFS

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT01301820

First Posted

February 4, 2011

Last Updated

March 15, 2016

Sponsor

French Innovative Leukemia Organisation

Collaborators

Celgene Corporation

1. Study Identification

Unique Protocol Identification Number

NCT01301820

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

March 2016

Overall Recruitment Status

Completed

Study Start Date

January 2011 (undefined)

Primary Completion Date

February 2013 (Actual)

Study Completion Date

February 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

French Innovative Leukemia Organisation

Collaborators

Celgene Corporation

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myeloid Leukemia

Keywords

maintenance treatment, Disease free survival

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Actual)

8. Arms, Groups, and Interventions

Arm Title

ARM A

Arm Type

Other

Arm Description

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

Arm Title

ARM B

Arm Type

Other

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

azacitidine

Other Intervention Name(s)

vidaza®

Intervention Description

azacitidine sc 75 mg/m²/d (d1- d7)

Intervention Type

Drug

Intervention Name(s)

Lenalidomide

Other Intervention Name(s)

revlimid®

Intervention Description

lenalidomide 10mg/d (d1- d21)

Primary Outcome Measure Information:

Title

DFS

Description

Time Frame

18 months

Secondary Outcome Measure Information:

Title

relapse incidence OS EFS Infectious events

Description

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.

Time Frame

until death

Title

gene expression and promoter methylation signatures associated with CR

Description

Time Frame

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mathilde HUNAULT BERGER, MD PD

Organizational Affiliation

French Innovative Leukemia Organisation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mathilde HUNAULT BERGER

City

Angers

ZIP/Postal Code

49033

Country

France

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

http://www.filo-leucemie.org

Description

FILO Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs