CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Lenalidomidedrug
Likely dose
Lenalidomide 2 mg/kgfrom 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/NCT02538965
NCT02538965Phase 2Completed
CompareCT.gov

A Phase 2, Multicenter, Single-arm, Open-label Study to Evaluate the Activity, Safety and Pharmacokinetics of Lenalidomide (Revlimid®) in Pediatric Subjects From 1 to = 18 Years of Age With Relapsed or Refractory Acute Myeloid Leukemia.

Celgene·interventional·Posted Sep 2, 2015·Updated Jan 7, 2020

In Brief

A Phase 2 clinical trial evaluating Lenalidomide for Leukemia, Myeloid. Completed, enrolled 17 participants across 62 sites in 2 countries.

Detailed Summary

To determine the activity of lenalidomide in the treatment of pediatric subjects with relapsed/refractory acute myeloid leukemia (AML) (with second or greater relapse or refractory to at least 2 prior induction attempts) measured by morphological complete response defined as either a CR or CRi within the first 4 cycles of treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, Myeloid
CountriesCanada, United States
Collaborators--

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 2, 2015
Enrollment StartNov 19, 2015
Primary CompletionJul 22, 2017
Study CompletionJan 11, 2019
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 10.8 years ago

Interventions

Lenalidomidedrug

Lenalidomide will be administered orally once daily for the first 21 days of every 28-day cycle. The starting dose will be 2 mg/kg/day with a maximum dose of 70 mg/day. Number of cycles: 12, or until evidence of progressive disease. Participants will also be discontinued if unresolved toxicities as described in the protocol occur, or if dose reductions are required and subject does not tolerate minimum dose level of 1mg/kg/day.