NCT00480064

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
360

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Jul 1995

Longer than P75 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 1995

Completed
11.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 30, 2007

Completed
Last Updated

May 30, 2007

Status Verified

May 1, 2007

First QC Date

May 29, 2007

Last Update Submit

May 29, 2007

Conditions

Acute Myeloid Leukemia

Keywords

AMLolder patientslomustine

Outcome Measures

Primary Outcomes (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

    13 months

Secondary Outcomes (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.

    13 months

Interventions

Lomustine, intermediate dose cytarabineDRUG

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Josy REIFFERS, MD MS

Pessac, 33604, France

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Lomustine

Condition Hierarchy (Ancestors)

Leukemia, MyeloidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Nitrosourea CompoundsUreaAmidesOrganic ChemicalsNitroso Compounds

Study Officials

  • JOSY REIFFERS, MD

    CHU Haut-Leveque Pessac 33604 France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2007

First Posted

May 30, 2007

Study Start

July 1, 1995

Study Completion

May 1, 2007

Last Updated

May 30, 2007

Record last verified: 2007-05

Locations

FR(1)