Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old

Study Overview
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Brief Summary
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A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

Detailed Description
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Principal Objective: The primary objective of this study is to assess the ability of lomustine to increase the overall survival by adding lomustine to induction and post-remission chemotherapy. Secondary Objectives: To assess the ability of lomustine to increase the CR rate. To assess the ability of lomustine to increase the event-free survival. To evaluate the toxicity and side-effects of lomustine. To evaluate the feasibility of reduced conditioning allogeneic transplantation *between 60 and 65 years old. To evaluate prognostic factors. To evaluate QOL in elderly. Study design: Parallel Study plan: Induction therapy: Patients will be randomized to receive idarubicin (5d) plus cytarabine or the same drugs plus lomustine, the latter given at the dose of 200 mg/m2 orally at day 1. Consolidation therapy: After completing induction treatment, patients who are in complete remission will receive a course of consolidation therapy with idarubicin (3d) and subcutaneous cytarabine. Maintenance therapy: In all patients with persisting CR one month after completing consolidation: six courses of monthly combination chemotherapy (idarubicin (1d) and subcutaneous cytarabine) and then a continuous regimen of methotrexate and 6-mercaptopurine, for 6 months. Allogeneic transplantation: Patients between 60 and 65 years old with a full matched donor will receive after consolidation (if still in CR) an alloBMT with a reduced conditioning regimen of Fludarabine (3d) and TBI (2Gy). Number of subjects: 460

Official Title
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Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old

Conditions
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Acute Myeloid Leukemia

Intervention / Treatment
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* Drug: Lomustine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 60 years and older with de novo AML and non-poor cytogenetic features. Patients with no unfavourable cytogenetic (based on GOELAMS-BGMT criteria) Performance status and Sorror score < 3 . Signed and dated informed consent. Exclusion Criteria: Acute promyelocytic leukemia. Patients with myeloproliferative syndromes prior to diagnosis of AML. Patients who previously had myelodysplastic syndrome. Positive serology for HIV. Patients with unfavourable cytogenetic Patients with an isolated medullary extra localization of their disease

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients will be treated by adding lomustine to chemotherapy | Drug: Lomustine<br>* Induction: chemotherapy + lomustine (CCNU), 200 mg/m2 orally at day 1. Consolidation: chemotherapy + lomustine (CCNU), 80 mg orally at day 1. Reinductions: chemotherapy + lomustine (CCNU), 40 mg orally at day 1.<br>|
| No Intervention: 2<br>Patients will be treated without adding lomustine to chemotherapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete remission |  | 1 year | 
| Event-free survival |  | 1 year | 
| Prognostic factors |  | 1 year | 
| Quality of Life (QOL) |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AML, Chemotherapy, older, De novo AML