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

Phase 3

Completed

• Conditions: Acute Myeloid Leukemia
• Interventions: Drug: Lomustine

• Registration Number: NCT00590837
• Lead Sponsor: University Hospital, Bordeaux

Brief Summary

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

* 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

Study Timeline

• Study First Submitted: 2007-12-27
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-11
• Study Start: 2008-02
• Primary Completion: 2012-12
• Study Completion: 2013-12
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-01
• Last Update Posted: 2014-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 459

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Lomustine	Patients will be treated by adding lomustine to chemotherapy

Primary Outcome Measures

Name	Time	Method
Overall Survival	1 year

Secondary Outcome Measures

Name	Time	Method
Complete remission	1 year
Event-free survival	1 year
Prognostic factors	1 year
Quality of Life (QOL)	1 year

Trial Locations

Locations (32)

Services maladies du sang, cancérologie, Hôpital Sud, CHU Amiens; 🇫🇷 Amiens, France

Service des maladies du sang, Centre Hospitalier Universitaire d'Angers; 🇫🇷 Angers, France

Service Hématologie, Centre Hospitalier Annecy; 🇫🇷 Annecy, France

C.H Victor Dupouy; 🇫🇷 Argenteuil, France

Service Médecine Interne, Onco-Hématologie, Maladies Infectieuses, Hôpital Henri Duffaut, Centre Hospitalier Avignon; 🇫🇷 Avignon, France

Service Hématologie, Centre Hospitalier de la Côte Basque; 🇫🇷 Bayonne, France

Service Hématologie, Hôpital Minjoz; 🇫🇷 Besançon, France

Unité Hématologie, Centre Hospitalier Blois; 🇫🇷 Blois, France

Service des maladies du sang - Hôpital Haut-Lévêque; 🇫🇷 Bordeaux - Pessac, France

Service Hématologie, Hôpital Dr Duchenne; 🇫🇷 Boulogne-sur-Mer, France

Scroll for more (22 remaining)