Adding Lomustine to Chemotherapy in Older Patients With Acute Myelogenous Leukemia (AML), and Allogeneic Transplantation for Patients From 60 to 65 Years Old (LAM-SA 2007)

University Hospital of Bordeaux

Status and phase: Completed; Phase 3

Conditions: Acute Myeloid Leukemia

Treatments: Drug: Lomustine

Study type: Interventional

Funder types: Other

Identifiers

NCT00590837

CHUBX 2007/13

Details and patient eligibility

About

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.

Full 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

Enrollment: 459 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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459 participants in 2 patient groups

1

Experimental group

Description:

Patients will be treated by adding lomustine to chemotherapy

Treatment:

Drug: Lomustine

2

No Intervention group

Description:

Patients will be treated without adding lomustine to chemotherapy