ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Brief Summary

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A Randomized Multicenter Phase III Study to Evaluate the Role of All-trans Retinoic Acid (ATRA) in Combination with Induction Chemotherapy, or Azacitidine and Idarubicin as salvage therapy and Idarubicin with Cytarabine or Azacitidine as Maintenance Therapy in Older Patients with Acute Myeloblastic Leukemia (AML).

To compare the outcome of elderly patients with newly-diagnosed AML treated with standard induction chemotherapy and post-remission therapy, in only patients in CR, with either azacitidine or cytarabine combined to idarubicin +/- ATRA and salvage therapy with azacitidine combined to idarubicin +/- ATRA.

Detailed Description

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Induction therapy :

First randomization (R1) at baseline : ATRA versus no ATRA.

Salvage therapy :

No conventional salvage therapy is planned. Patients who will not achieve CR, according to IWG criteria after induction will be treated with 3 courses of azacitidine and idarubicin +/- ATRA combination, if eligible for further treatment.

Followed by 3 identical courses and 6 courses of maintenance by azacitidine alone to be delivered every 28 days, in those patients reaching CR or PR after 3 courses (evaluation of response from 28 to 56 days from course 3).

Randomization R2: type of maintenance:

Response to induction will be evaluated 2 weeks after myeloid recovery, just before first consolidation course, due use of to pegfilgrastim, lenograstim or filgrastim during induction.

Responses will be classified according to the Revised Recommendations of the IWG for AML.

Patients in CR only will be subjected to a second randomization R2 as follows 6 courses of combined chemotherapy, will be delivered as outpatients, ATRA according to R1 randomization.

Conditions

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Acute Myeloid Leukemia

Keywords

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Acute Myeloid Leukemia Aged of 65 to 79 years Older Patients with Acute Myeloblastic Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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R1 Arm A : ATRA

Idarubicin: 9 mg/m2/d D1 to D4 Cytarabine : 200 mg/m2/d Continuous IV from D1 to D7 Peg-filgrastim : 6 mg SC D9 or filgrastim 5ug/kg/d SC or lenograstim 263ug/d IV 30mn, both from D9 to myeloid recovery(PMN \>1G/l over 2 days at minimum

All-trans retinoic acid (ATRA): 45mg/m2/day in two divided doses from D8 to D28

Group Type EXPERIMENTAL

Vesanoid (ATRA)

Intervention Type DRUG

45 mg/m2/day in two divided doses from D8 to D28

R1 Arm B : no ATRA

Idarubicin: 9 mg/m2/d D1 to D4 Cytarabine : 200 mg/m2/d Continuous IV from D1 to D7 Peg-filgrastim : 6 mg SC D9 or filgrastim 5ug/kg/d SC or lenograstim 263ug/d IV 30mn, both from D9 to myeloid recovery(PMN \>1G/l over 2 days at minimum

Intervention Type DRUG

Cytarabine : 60 mg/m2/12h SC from D1 to D5

Interventions

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Vesanoid (ATRA)

45 mg/m2/day in two divided doses from D8 to D28

Intervention Type DRUG

AZACITIDINE (VIDAZA)

75 mg/m2/12h SC from D1 to D5

Intervention Type DRUG

CYTARABINE

Cytarabine : 60 mg/m2/12h SC from D1 to D5

Intervention Type DRUG

Other Intervention Names

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VEZANOIDE

Eligibility Criteria

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Inclusion Criteria

1. Aged of 65 to 79 years
2. With a morphologically proven diagnosis of AML according to WHO classification either de novo or AML with "myelodysplasia related changes"
3. Not previously treated for AML
4. Signed informed consent.

Exclusion Criteria

1. APL in the WHO classification.
2. Ph1-positive AML or prior Ph1-positive disease
3. AML evolving from a prior MPN in the WHO 2008 classification.
4. Prior treatment with chemotherapy or radiotherapy for another tumor
5. Prior tumor, if not stable for at least two years, except in-situ carcinoma and skin carcinoma
6. Prior advanced malignant hepatic tumor
7. ECOG Performance Status Score \> 2
8. Creatinine level more than 2x's the upper limit of the normal range (ULN) at the laboratory where the analysis was performed, except if AML-related.
9. Total serum bilirubin more than 2x's the ULN at the laboratory where the analysis was performed, except if AML-related.
10. AST (SGOT) or ALT (SGPT) more than 2.5x's the ULN at the laboratory where the analysis was performed, except if AML-related
11. LVEF less than.55 or equivalent by doppler echocardiography
12. Known intolerance to Azacitidine, mannitol, retinoids
13. Positive serum test for HIV and HTLV-1
14. NYHA Grade 3/4 cardiac disease .
15. Severe infection at inclusion time.
16. Psychiatric disease or an history of non-compliance to medical regimens or patients considered potentially unreliable.
17. Absence of health care insurance (affiliation à un régime de Sécurité Sociale)
18. Participation to any study requiring informed consent

Minimum Eligible Age

65 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Avicenne Hospital- Hôpital Avicenne, AP-HP Bobigny

Principal Investigators

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GARDIN CLAUDE, MD

Role: PRINCIPAL_INVESTIGATOR

Acute Leukemia French Association

Review additional registry numbers or institutional identifiers associated with this trial.

ALFA-0703 Study - P060205

Identifier Type: -

Identifier Source: org_study_id

ALFA-0703 Study in Older Patients With Acute Myeloblastic Leukemia (AML)

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

R1 Arm A : ATRA

Vesanoid (ATRA)

R1 Arm B : no ATRA

R2 Arm 1A : AZACITIDINE and ATRA

Vesanoid (ATRA)

AZACITIDINE (VIDAZA)

R2 Arm 1B : AZACITIDINE and No ATRA

AZACITIDINE (VIDAZA)

R2 Arm 2A : ATRA

Vesanoid (ATRA)

CYTARABINE

R2 Arm 2B : no ATRA

CYTARABINE

Interventions

Vesanoid (ATRA)

AZACITIDINE (VIDAZA)

CYTARABINE

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Assistance Publique - Hôpitaux de Paris

Acute Leukemia French Association

Responsible Party

Principal Investigators

GARDIN CLAUDE, MD

Locations

Chu Amiens Sud

CH

Hopital Avicenne

Chu Boulogne Sur Mer

CH

Hopital Percy

Ch Sud Francilien

Hopital Henri Mondor

Ch Dunkerque

CH

CHU

CH

Hopital Edouard Herriot

CH

Centre Antoine Lacassagne

St Antoine Hospital

Necker Hospital

Hopital Pitie-Salpetriere

Hopital Saint-Louis

Ch Rene Dubos

CH

CHU

CNLCC

CH

CH

IGR

Countries

Other Identifiers

ALFA-0703 Study - P060205