CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 74 enrolled
Drug / intervention
clofarabine +3 moredrug
Likely dose
Not stated in 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/NCT00372619
NCT00372619Phase 2Completed

A Phase I/II Study of CLOLAR® (Clofarabine, IND# 73, 789) in Combination With Cytarabine in Pediatric Patients With Refractory/Relapsed Leukemia

Children's Oncology Group·interventional·Posted Sep 7, 2006·Updated Jun 5, 2017

In Brief

A Phase 2 clinical trial evaluating clofarabine, cytarabine, and 2 other interventions for Leukemia. Completed, enrolled 74 participants across 79 sites in 2 countries.

Detailed Summary

RATIONALE: Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of clofarabine when given together with cytarabine and to see how well they work in treating young patients with refractory or relapsed acute myeloid leukemia or acute lymphoblastic leukemia. (Phase I closed to enrollment as of 09/16/09)

Study Details

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

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 7, 2006
Enrollment StartMar 1, 2007
Primary CompletionAug 1, 2012
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 19.8 years ago

Interventions

clofarabinedrug

Given IV for 5 days

cytarabinedrug

Given IV

methotrexatedrug

Given intrathecally or IT age based dosage

laboratory biomarker analysisother