Lomustine and Intermediate Dose Cytarabine in Older Patients With AML

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00480064
Recruitment Status : Completed
First Posted : May 30, 2007
Last Update Posted : May 30, 2007
Information provided by:
French Innovative Leukemia Organisation

May 29, 2007
May 30, 2007
May 30, 2007
July 1995
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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 [ Time Frame: 13 months ]
Same as current
No Changes Posted
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. [ Time Frame: 13 months ]
Same as current
Not Provided
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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
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 .

Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Acute Myeloid Leukemia
Drug: Lomustine, intermediate dose cytarabine
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
May 2007
Not Provided

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
Sexes Eligible for Study: All
60 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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French Innovative Leukemia Organisation
Not Provided
Principal Investigator: JOSY REIFFERS, MD CHU Haut-Leveque Pessac 33604 France
French Innovative Leukemia Organisation
May 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP