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Acute Myeloid LeukemiaPhase 3ALFA-0703NCT01067274

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

A Phase 3 study testing Vesanoid (ATRA), AZACITIDINE (VIDAZA) and CYTARABINE in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association at 26 sites in France.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 65 to 79 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Vesanoid (ATRA), AZACITIDINE (VIDAZA) and CYTARABINE
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
26 sitesFrance
Study dates
Apr 2010to Apr 2016
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 79 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

26 sites in 1 country.

26 sites in 1 country

France26 sites

  • Chu Amiens Sud

    Amiens, 80054

  • CH

    Argenteuil, 95107

  • Hopital Avicenne

    Bobigny

  • Chu Boulogne Sur Mer

    Boulogne-sur-Mer, 62321

  • CH

    Caen, 14033

  • Hopital Percy

    Clamart, 92141

  • Ch Sud Francilien

    Corbeil-Essonnes, 94010

  • Hopital Henri Mondor

    Créteil

  • Ch Dunkerque

    Dunkirk, 59385

  • CH

    Lens, 62307

  • CHU

    Lille, 59037

  • CH

    Limoges, 87042

  • Hopital Edouard Herriot

    Lyon

  • CH

    Meaux, 77104

  • Centre Antoine Lacassagne

    Nice, 06189

  • St Antoine Hospital

    Paris, 75012

  • Necker Hospital

    Paris, 75015

  • Hopital Pitie-Salpetriere

    Paris, 75651

  • Hopital Saint-Louis

    Paris

  • Ch Rene Dubos

    Pontoise, 95303

  • CH

    Roubaix, 59100

  • CHU

    Rouen, 76038

  • CNLCC

    Saint-Cloud, 92210

  • CH

    Valenciennes, 59322

  • CH

    Versailles

  • IGR

    Villejuif

Other trials in France

About this study

Official title: 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)

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.

Read the detailed description

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.

Being tested
Vesanoid (ATRA), AZACITIDINE (VIDAZA), CYTARABINE
Keywords
Acute Myeloid Leukemia, Aged of 65 to 79 years, Older Patients with Acute Myeloblastic Leukemia
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vesanoid (ATRA)Drug

    Also called VEZANOIDE

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

  • AZACITIDINE (VIDAZA)Drug

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

  • CYTARABINEDrug

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

Study groups in NCT01067274
Study groupRoleWhat they receive
R1 Arm A : ATRAExperimentalIdarubicin: 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
Receives: Drug: Vesanoid (ATRA)
R1 Arm B : no ATRANo interventionIdarubicin: 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
R2 Arm 1A : AZACITIDINE and ATRAExperimentalAzacitidine: 75 mg/m2/12h SC from D1 to D5 Idarubicine: 9 mg/m2/d IV on D5 All-trans retinoic acid (ATRA): 45mg/m2/d in two divided doses from D8 to D21
Receives: Drug: Vesanoid (ATRA); Drug: AZACITIDINE (VIDAZA)
R2 Arm 1B : AZACITIDINE and No ATRAExperimentalAzacitidine: 75 mg/m2/12h SC from D1 to D5 Idarubicine: 9 mg/m2/d IV on D5
Receives: Drug: AZACITIDINE (VIDAZA)
R2 Arm 2A : ATRAExperimentalIdarubicine : 9 mg/m2/d IV on D1 Cytarabine : 60 mg/m2/12h SC from D1 to D5 All-trans retinoic acid (ATRA): 45mg/ m2/d in two divided doses from D8 to D21
Receives: Drug: Vesanoid (ATRA); Drug: CYTARABINE
R2 Arm 2B : no ATRAExperimentalIdarubicine : 9 mg/m2/d IV on D1 Cytarabine : 60 mg/m2/12h SC from D1 to D5
Receives: Drug: CYTARABINE

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. For randomization R1, the primary endpoint is Event-free Survival (EFS)

    Measured: 2-year EFS

  2. For randomization R2, the primary endpoint is disease free survival (DFS)

    Measured: 2-year DFS

Secondary outcomes (5)

  1. Complete Response (CR) rate

    Measured: 2 years

  2. Overall survival

    Measured: 2 years

  3. Response rate to azacitidine idarubicin +/-ATRA combination after intensive chemotherapy failure and identification of possible predictors of response to this therapy

    Measured: 2 years

  4. Assess the safety of combination ATRA + chemotherapy or idarubicin-azacitidine courses and of maintenance with azacitidine

    Measured: 2 years

  5. Effects on relapse rates of ATRA and maintenance, with respect to cytogenetics risk groups, subtypes of AML and mutational status (FLT3, MLL), and biomarkers

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Feb 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionApr 2016 (estimated)

Why it stopped: Study abandoned

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01067274
Sponsor's protocol ID
ALFA-0703 Study - P060205
Acronym
ALFA-0703
Status last verified
Feb 2010
First submitted
10 Feb 2010
Last updated
30 Dec 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vesanoid (ATRA), AZACITIDINE (VIDAZA) and CYTARABINE in people with Acute Myeloid Leukemia, run by Acute Leukemia French Association at 26 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 30 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 26 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

For randomization R1, the primary endpoint is Event-free Survival (EFS) (time frame: 2-year EFS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01067274.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2015.

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