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Clofarabine + Cytarabine + G-CSF (GCLAC) in Newly Diagnosed AML/MDS/MPN

NCT01101880Phase 2

Key facts

Status: Completed
Start: Aug 2010
Primary completion: Jun 2013
Countries: 1
Sponsor: University of Washington
Modality: Orthosteric Ligands, Metabolically Activated Prodrugs

Drugs: clofarabine
Conditions: acute myeloid leukemia (AML)myelodysplastic syndrome (MDS)Myeloproliferative Neoplasm (MPN)

Overview

Phase 2, open-label, single-arm trial of clofarabine in acute myeloid leukemia (AML), myelodysplastic syndrome (MDS) and Myeloproliferative Neoplasm (MPN), sponsored by University of Washington. Primary endpoints: Complete Remission Rate up to 5 years and Complete Remission With Incomplete Recovery of Counts Rate up to 5 years. Started Aug 2010; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-label

Treatment (GCLAC)
Clofarabine + Cytarabine + Filgrastim

Who it enrols

Adults <65 with newly diagnosed AML, advanced MDS, or advanced MPN, adequate organ function, and no prior induction chemotherapy.

Endpoints

Primary

Complete Remission RateUp to 5 years
Complete Remission With Incomplete Recovery of Counts RateUp to 5 years

Secondary

Event Free SurvivalUp to 5 years
Overall SurvivalUp to 5 years
Treatment-related MortalityUp to 5 years
Toxicity AssessmentUp to 5 years
Duration of RemissionUp to 5 years
Time to ProgressionUp to 5 years

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