Gemtuzumab Ozogamicin+Cytarabine vs Idarubicin+Cytarabine in Elderly Patients With AML.Mylofrance 4

NCT ID: NCT02473146

Last Updated: 2024-02-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-18
• Study Completion Date: 2023-09-07

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

Gemtuzumab ozogamicin (GO)

Intervention Type: DRUG

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Gemtuzumab ozogamicin (GO)

Intervention Type: DRUG

Other Intervention Names

Mylotarg

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ms Juliette LAMBERT

Clinical coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliette LAMBERT, MD

Role: PRINCIPAL_INVESTIGATOR

Versailles Hospital

Sylvie CASTAIGNE, MD

Role: PRINCIPAL_INVESTIGATOR

Versailles Hospital

Locations

C.H.U d'Amiens - Hôpital Sud

Amiens, , France

Hôpital V. Dupouy

Argenteuil, , France

CH Avicenne

Bobigny, , France

CHU Caen

Caen, , France

HIA Percy

Clamart, , France

Hopital Henri Mondor

Créteil, , France

CHU Dijon

Dijon, , France

CH Dunkerque

Dunkirk, , France

CH Versailles

Le Chesnay, , France

Hôpital Huriez, CHU de Lille

Lille, , France

CHU Limoges

Limoges, , France

Hôpital de la Conception

Marseille, , France

Centre Antoine Lacassagne

Nice, , France

CHU d'Orléans

Orléans, , France

Hopital Necker

Paris, , France

Hopital St Louis

Paris, , France

Hôpital Saint Antoine

Paris, , France

CHU Lyon Sud

Pierre-Bénite, , France

Centre H Becquerel

Rouen, , France

Institut de Cancérologie de la Loire

Saint-Priest-en-Jarez, , France

IGR

Villejuif, , France

Countries

France

Other Identifiers

2014-001395-65

Identifier Type: -

Identifier Source: org_study_id