CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
Cladribine +5 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/NCT02921061
NCT02921061Phase 2Completed

Phase 1/2 Study of Concurrent Decitabine in Combination With G-CSF, Cladribine, Cytarabine, and Mitoxantrone (G-CLAM) in Adults With Newly Diagnosed Acute Myeloid Leukemia (AML) or High-Risk Myelodysplastic Syndromes (MDS)

Fred Hutchinson Cancer Center·interventional·Posted Sep 30, 2016·Updated Mar 17, 2020

In Brief

A Phase 2 clinical trial evaluating Cladribine, Cytarabine, and 4 other interventions for Mixed Phenotype Acute Leukemia and 6 related conditions. Completed, enrolled 28 participants across 1 site.

Detailed Summary

This phase I/II trial studies the side effects and best dose of decitabine when given together with filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride in treating patients with acute myeloid leukemia or myelodysplastic syndrome that is newly diagnosed, has come back or has not responded to treatment. Drugs used in chemotherapy, such as decitabine, 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. Colony-stimulating factors, such as filgrastim, may increase the production of blood cells and may help the immune system recover from the side effects of chemotherapy. Decitabine, filgrastim, cladribine, cytarabine, and mitoxantrone hydrochloride may work better in treating patients with acute myeloid leukemia and myelodysplastic syndrome.

Study Details

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedSep 30, 2016
Enrollment StartNov 17, 2016
Primary CompletionOct 24, 2018
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 9.8 years ago

Interventions

Cladribinedrug

Given IV

Cytarabinedrug

Given IV

Decitabinedrug

Given IV

Filgrastimbiological

Given SC

Laboratory Biomarker Analysisother

Correlative studies

Mitoxantrone Hydrochloridedrug

Given IV