Lomustine and Intermediate Dose Cytarabine in Older Patients With AML

Sponsor

French Innovative Leukemia Organisation (Other)

Overall Status

Completed

CT.gov ID

NCT00480064

Collaborator

(none)

360

Enrollment

Location

142

Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A multicenter randomized trial was performed comparing induction therapy (IC: Idarubicin and Cytarabine, 5+7) to ICL (the same drugs plus lomustine (CCNU), 200mg\m2 orally at day 1). Patients in complete remission (CR) were then randomized to receive either maintenance therapy or intensification with intermediate-dose cytarabine and idarubicin followed by maintenance therapy.

Condition or Disease	Intervention/Treatment	Phase
Acute Myeloid Leukemia	Drug: Lomustine, intermediate dose cytarabine	Phase 3

Detailed Description

Induction therapy: Patients were randomized to receive idarubicin plus cytarabine (IC) or the same drugs plus lomustine (ICL), the latter given at the dose of 200 mg/m2 orally at day 1. Patients with persistent leukemia in the bone marrow, defined by at least 20% marrow cellularity with more than 5% blasts on day 14 or at a subsequent time point following initiation of induction therapy, received a second course of induction chemotherapy identical to the initial induction course. Non-responders to the second induction course were taken off the protocol.

Consolidation therapy: After completing induction treatment, patients who were in complete remission after 1 or 2 induction courses received a course of consolidation (IC') therapy with idarubicin and subcutaneous cytarabine. Subsequently, if stable remission persisted, the patients received maintenance therapy or maintenance therapy preceded by a second consolidation (IIC) with intermediate-dose cytarabine. Randomization was performed as soon as CR was achieved.

Maintenance therapy: This was conducted in all patients with persisting CR one month after completing the first (IC) or second (IIC) consolidation and consisted of the following: five courses of combination chemotherapy at 1, 3, 6, 9 and 13 months from the last consolidation, namely cytarabine (subcutaneously) and idarubicin and between these courses for one year: a continuous regimen of methotrexate and 6-mercaptopurine, as alternating 10 day-courses .

Study Design

Study Type:

Interventional

Actual Enrollment :

360 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction Chemotherapy and Adding Intermediate Dose Cytarabine to Consolidation in Older Patients With Acute Myeloid Leukaemia

Study Start Date :

Jul 1, 1995

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Primary Outcomes: The primary objective of this study was to assess the ability of lomustine to increase the CR rate and to improve overall survival [13 months]

Secondary Outcome Measures

Secondary Outcomes: The secondary objective was to test intermediate-dose cytarabine on survival, and to analyze the impact of prognostic factors on CR and survival. [13 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patients aged 60 years and older with de novo AML according to FAB criteria
With normal cardiac function with left ventricular ejection fraction >= 50%, absence of unstable cardiac arrhythmia or unstable angina.
Unimpaired renal (creatinin <180µmol\L)
Unimpaired liver (bilirubin <35µmol\L) functions.
Performance status <3
Signed and dated informed consent.