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

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 Type : Interventional  (Clinical Trial)
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 : July 1995
Actual Study Completion Date : May 2007

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00480064

Pessac, France, 33604
Sponsors and Collaborators
French Innovative Leukemia Organisation
Principal Investigator: JOSY REIFFERS, MD CHU Haut-Leveque Pessac 33604 France Identifier: NCT00480064     History of Changes
Other Study ID Numbers: BGMT95-V
First Posted: May 30, 2007    Key Record Dates
Last Update Posted: May 30, 2007
Last Verified: May 2007

Keywords provided by French Innovative Leukemia Organisation:
older patients

Additional relevant MeSH terms:
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents, Alkylating
Alkylating Agents