CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 199 enrolled
Drug / intervention
Cladribine +4 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/NCT02044796
NCT02044796Phase 2Completed

A Phase 1/2 Trial of G-CSF, Cladribine, Cytarabine, and Dose-Escalated Mitoxantrone (G-CLAM) in Adults With Newly Diagnosed or Relapsed/Refractory Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS)

Fred Hutchinson Cancer Center·interventional·Posted Jan 24, 2014·Updated Jan 10, 2020

In Brief

A Phase 2 clinical trial evaluating Cladribine, Cytarabine, and 3 other interventions for Acute Biphenotypic Leukemia and 5 related conditions. Completed, enrolled 199 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of mitoxantrone hydrochloride when given together with filgrastim, cladribine, and cytarabine and to see how well they work in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes that is newly diagnosed, has returned, or does not respond to treatment. Drugs used in chemotherapy, such as filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Study Details

Timeline

Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJan 24, 2014
Enrollment StartJan 23, 2014
Primary CompletionMar 9, 2018
Study CompletionApr 16, 2018
TodayJul 2, 2026
Enrollment to primary: 4.1 yearsPosted 12.4 years ago

Interventions

Cladribinedrug

Given IV

Cytarabinedrug

Given IV

Filgrastimbiological

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Mitoxantrone Hydrochloridedrug

Given IV