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Lomustine and Intermediate Dose Cytarabine in Older Patients With AML

This study has been completed.
Sponsor:
Information provided by:
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
ClinicalTrials.gov Identifier:
NCT00480064
First received: May 29, 2007
Last updated: NA
Last verified: May 2007
History: No changes posted
  Purpose

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 Intervention Phase
Acute Myeloid Leukemia
 Drug: Lomustine, intermediate dose cytarabine
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:

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 [ Time Frame: 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. [ Time Frame: 13 months ]

Enrollment: 360
Study Start Date: July 1995
Study Completion Date: May 2007
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 .

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00480064

Locations
France
Josy REIFFERS, MD MS
Pessac, France, 33604
Sponsors and Collaborators
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS
Investigators
Principal Investigator: JOSY REIFFERS, MD CHU Haut-Leveque Pessac 33604 France
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00480064     History of Changes
Other Study ID Numbers: BGMT95-V
Study First Received: May 29, 2007
Last Updated: May 29, 2007
Health Authority: France: Ministry of Health

Keywords provided by Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS:
AML
older patients
lomustine

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

ClinicalTrials.gov processed this record on May 21, 2013