CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 459 enrolled
Drug / intervention
Lomustinedrug
Likely dose
Lomustine 200 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00590837
NCT00590837Phase 3Completed
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Randomized Prospective Study of Adding Lomustine to Idarubicin and Cytarabine for Induction and Post-remission Chemotherapy in Older Patients With Acute Myeloid Leukaemia, and Feasibility of Allogeneic Transplantation for Patients From 60 to 65 Years Old

University Hospital, Bordeaux·interventional·Posted Jan 11, 2008·Updated Apr 2, 2014

In Brief

A Phase 3 clinical trial evaluating Lomustine for Acute Myeloid Leukemia. Completed, enrolled 459 participants across 32 sites.

Detailed Summary

A multicenter randomized trial comparing induction therapy (IC: Idarubicin and Cytarabine, 5 + 7) to ICL (the same drugs plus lomustine (CCNU), 200 mg/m2 orally at day 1). Patients in complete remission (CR) will then receive a post-remission schedule with or without lomustine according to randomization. Patients from 60 to 65 years old will be proposed to reduced conditioning allogeneic transplantation after first consolidation.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia
CountriesFrance
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 11, 2008
Enrollment StartFeb 1, 2008
Primary CompletionDec 1, 2012
Study CompletionDec 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 18.5 years ago

Interventions

Lomustinedrug

Induction: chemotherapy + lomustine (CCNU), 200 mg/m2 orally at day 1. Consolidation: chemotherapy + lomustine (CCNU), 80 mg orally at day 1. Reinductions: chemotherapy + lomustine (CCNU), 40 mg orally at day 1.