- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02473146
Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4 (ALFA1401)
Etude Exploratoire randomisée Comparant le Traitement Par Gemtuzumab Ozogamicin /Cytarabine au Traitement Standard Par Idarubicine/Cytarabinechez Les Sujets âgés de 60 à 80 Ans et présentant Une LAM et un Caryotype Non défavorable
Purpose : The main objective of this study is to assess the efficacy and tolerance of the addition of repeated doses of low doses (3mg/m2) of Gemtuzumab Ozogamicin (GO) in addition with standard doses of Ara-C in previously untreated patients aged 60 to 80 years with de novo acute myeloblastic leukemia (AML) and non adverse cytogenetics. The main end point for efficacy is 2 years-event free survival. The secondary efficacy endpoints are CR/Cri rates, cumulative incidence of relapse and overall survival. The secondary endpoints for safety are early death rate (before day 30 and 60), grade 3 to 5 adverse events and severe adverse events, cardiac toxicity and quality of life. Additional secondary endpoints are treatment by covariate interactions with respect to biological characteristics present at diagnosis (CD33 positivity, cytogenetic, molecular abnormalities) or after treatment (Minimal residual disease levels). This study is an exploratory study. Patients will be allocated at inclusion with a 2/1 ratio either to receive treatment with GO and cytarabine or Idarubicin and cytarabine in a 3+7 regimen similar to the "backbone" ALFA 1200 scheme used concurrently by the ALFA group as treatment of AML patients aged >60 years.
Primary objective. The primary objective is to assess the efficacy of two doses of Gemtuzumab ozogamicin (GO) during induction and one dose of GO during first consolidation in combination with Cytarabine in elderly patients with AML in the non adverse cytogenetics-risk group.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Contact
- Name: Laure MORISSET
- Phone Number: 0139239785
- Email: lmorisset@ch-versailles.fr
Study Contact Backup
- Name: Assitan KONE
- Phone Number: 0139239775
- Email: akone@ch-versailles.fr
Study Locations
-
-
-
Amiens, France
- C.H.U d'Amiens - Hôpital Sud
-
Argenteuil, France
- Hôpital V. Dupouy
-
Bobigny, France
- CH Avicenne
-
Caen, France
- CHU Caen
-
Clamart, France, 92140
- HIA Percy
-
Creteil, France
- Hôpital Henri Mondor
-
Dijon, France
- CHU Dijon
-
Dunkerque, France
- Ch Dunkerque
-
Le Chesnay, France, 78157
- CH Versailles
-
Lille, France
- Hôpital Huriez, CHU de Lille
-
Limoges, France
- CHU Limoges
-
Marseille, France, 13005
- Hopital de la Conception
-
Nice, France, 06100
- Centre Antoine Lacassagne
-
Orléans, France, 45100
- CHU d'ORLEANS
-
Paris, France
- Hopital Saint Antoine
-
Paris, France
- Hôpital Necker
-
Paris, France
- Hopital St Louis
-
Pierre Benite, France
- CHU Lyon Sud
-
Rouen, France
- Centre H Becquerel
-
Saint-Priest-en-Jarez, France, 42270
- Institut de Cancerologie de la Loire
-
Villejuif, France
- IGR
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with a morphologically proven diagnosis AML and both the following criteria:
- Age ≥ 60 years and < 80 years.
- Not previously treated for their disease.
- With favourable or intermediate-risk cytogenetics. (Patients with urgent clinical need to begin treatment might be included before cytogenetic results, when necessary if they do not respond to Hydroxyurea. Patients might be included if the cytogenetic results are not expected in a time limit < 5 days after AML diagnosis).
- Fit to receive intensive chemotherapy
- Cardiac function determined by radionucleide or echography within normal limits.
- Signed informed consent
Exclusion Criteria:
- M3-AML
- Presence of adverse cytogenetics (according to European LeukemiaNet recommendation.) (17) defined as one of the following abnormalities: -5/5q-, -7, t(6;9), t(v;11q23) excluding t(9;11), inv(3)(q21;q26.2) or t(3;3)(q21;q26.2), complex karyotype (3+ abnormalities)
- Secondary AML following treatment with radiotherapy or chemotherapy.
- AML following previously known myeloproliferative or myelodysplastic syndrome.
- ECOG performance status (PS) 0 to 3
- Serum creatinin level > or = 2.5N; AST and ALT level > or = 2.5N; total bilirubin level > or = 2N
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Mylotarg Arm
After randomization patients in the experimental arm are assigned to receive chemotherapy with: Gemtuzumab Ozogamicin 3 mg/m2 (maximum dose: 5 mg) per IV, 60mn on Day 1 and 4 Cytarabine 200 mg/m2 per CIV over 24h on Day 1 to 7 |
Other Names:
|
No Intervention: Control Arm
After randomization patients in the control arm are assigned to receive chemotherapy with Idarubicin 12mg/m2 per IV, 30mn on Day 1,2,3 Cytarabine 200 mg/m2 per CIV over 24h on Day 1 to 7
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EFS (defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death)
Time Frame: 5 years
|
Endoint for the primary objective of efficacy is EFS defined as the time from randomization to the date of assessment of response if CR or Cri had not been achieved, relapse or death.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite measure for Efficacy assessed by CR/Cri rates, cumulative incidence of relapse, overall survival.
Time Frame: 5 years
|
5 years
|
|
Composite measure for safety
Time Frame: 5 years
|
End points for treatment-by-covariate interactions are
|
5 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Juliette LAMBERT, MD, Versailles Hospital
- Principal Investigator: Sylvie CASTAIGNE, MD, Versailles Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2014-001395-65
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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