CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 151 enrolled
Drug / intervention
Cytarabine +1 moredrug
Likely dose
Fludarabine 15 mgfrom 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/NCT01019317
NCT01019317Phase 2Completed
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A Phase II Study of Twice Daily Cytarabine and Fludarabine in Acute Myelogenous Leukemia and High-Risk Myelodysplastic Syndrome

M.D. Anderson Cancer Center·interventional·Posted Nov 25, 2009·Updated Mar 15, 2016

In Brief

A Phase 2 clinical trial evaluating Cytarabine and Fludarabine for Leukemia and 3 related conditions. Completed, enrolled 151 participants across 1 site.

Detailed Summary

The goal of this clinical research study is to learn if the combination of fludarabine and cytarabine can help to control Acute Myelogenous Leukemia (AML), High-Risk Myelodysplastic Syndrome (MDS) or Chronic Myeloid Leukemia (CML) in myeloid blast crisis. The safety of this drug combination will also be studied.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLeukemia, AML, MDS, CML
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2009
Enrollment StartNov 1, 2009
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 16.6 years ago

Interventions

Cytarabinedrug

0.5 grams/m\^2 over 2 hours(+/- 15 minutes) IV every 12 (+/-2) hours for 5 days (4 days in patients \> 65 years and 3 days in patients with Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 3).

Fludarabinedrug

15 mg/m\^2 to be given IV over 15-30 minutes every 12 (+/- 2) hours for 5 days. (4 days in patients \> 65 years and 3 days in patients with PS \> 3).