Trial | NCT00480064  Report issue

Title

Lomustine and Intermediate Dose Cytarabine in Older Patients With AML
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    360
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.
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 Started
Jul 31
1995
Study Completion
May 31
2007
Last Update
May 30
2007
Estimate

Drug Lomustine, intermediate dose cytarabine

Criteria 

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.

Exclusion Criteria:

Acute promyelocytic leukemia
Patients with myeloproliferative syndromes prior to diagnosis of AML
Patients who previously had myelodysplastic syndrome
Patients pretreated with chemo- or radiotherapy
Performance status <2
Positive serology for HIV
No Results Posted