CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 116 enrolled
Drug / intervention
Clofarabine 40mg/m^2 +5 moredrug
Likely dose
Clofarabine 40 mg/m² IV daily × 5 days plus Idarubicin 10 mg/m² IV daily × 3 days plus Ara-C 0.75 g/m² IV daily × 5 days (or alternative combinations with lower clofarabine and higher ara-C doses)AI-extracted
Key inclusion· 4
  • ✓Age 18 to <60 years
  • ✓First relapse of AML, or first salvage of primary refractory AML, or high-grade MDS (≥10% blasts) with ≤1 prior chemotherapy regimen, or CML in myeloid blast phase (frontline or first salvage)
  • ✓Total bilirubin ≤2 mg/dL, SGPT ≤4× ULN, creatinine ≤2.0 mg/dL
  • ✓ECOG performance status ≤2
Key exclusion· 5
  • ✕Prior clofarabine treatment
  • ✕Active, uncontrolled systemic infection considered opportunistic, life-threatening, or clinically significant; any severe concurrent disease that would make the patient inappropriate for study entry
  • ✕Symptomatic CNS involvement
  • ✕Other concurrent chemotherapy; must be off previous therapy for ≥2 weeks and recovered from acute toxicity

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

Search/NCT00067028
NCT00067028Phase 2Completed
CompareCT.gov

A Prospective Randomized Phase I/II Study of Clofarabine (Clo) and Ara-C vs Clo and Ida vs Clo Plus Ida and Ara-C in Patients With First Relapse or First Salvage of Primary Refractory AML; and High-Grade MDS(>/= 10% Blasts); or CML in Myeloid Blasts Phase as Front Line Therapy or in First Salvage.

M.D. Anderson Cancer Center·interventional·Posted Aug 13, 2003·Updated Dec 8, 2020

In Brief

A Phase 2 clinical trial evaluating Clofarabine 40mg/m^2, Idarubicin 10mg/m^2, and 4 other interventions for Acute Myeloid Leukemia and 2 related conditions. Completed, enrolled 116 participants across 1 site.

Detailed Summary

The goal is to compare the drug combinations clofarabine/idarubicin/ara-C, clofarabine/ara-C, and clofarabine/idarubicin in the treatment of patients with Acute Myeloid Leukemia, high-grade MDS, or myeloid blast phase of Chronic Myeloid Leukemia who have relapsed following their initial therapy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Myeloid Leukemia, Myelodysplastic Syndrome, Chronic Myeloid Leukemia
CountriesUnited States
CollaboratorsGenzyme, a Sanofi Company

Timeline

Phase 2CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 13, 2003
Enrollment StartDec 1, 2003
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 9.5 yearsPosted 22.9 years ago

Interventions

Clofarabine 40mg/m^2drug

40 mg/m\^2 by vein over 1 hour daily for 5 days.

Idarubicin 10mg/m^2drug

10 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle. Clofarabine + Idarubicin plus Ara-C: 6 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.

Ara-C 0.75 g/m^2drug

0.75 g/m\^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.

Clofarabine 22.5mg/m^2drug

22.5 mg/m\^2 by vein over 1 hour daily for 5 days.

Ara-C 1 g/m^2drug

1 g/m\^2 by vein over 2 hours for 5 days in a row, on Days 1 to 5 of each cycle.

Idarubicin 6 mg/m^2drug

6 mg/m\^2 by vein over 30 minutes, around one hour after clofarabine, for the first 3 days of 5 day cycle.