Trial intelligence / Profile preview

Alternating Nilotinib and Imatinib in Elderly/Unfit Ph+ ALL

NCT01025505Phase 2

Key facts

Status: Completed
Start: Jun 2012
Primary completion: Dec 2015
Countries: 1
Sponsor: GIMEMA
Modality: Small Molecules

Drugs: nilotinibimatinib
Conditions: acute lymphoblastic leukemia (ALL)

Overview

Phase 2, open-label, single-arm trial of nilotinib and imatinib in acute lymphoblastic leukemia (ALL), sponsored by GIMEMA. Primary endpoint: Disease-Free Survival at 24 months. Started Jun 2012; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

Nilotinib/Imatinib Alternating
Alternating courses of Nilotinib and Imatinib every 6 weeks for 4 courses.

Who it enrols

Adult patients (>60 years or >18 years and unfit for intensive therapy/SCT) with previously untreated Ph+/BCR-ABL+ acute lymphoblastic leukemia.

Endpoints

Primary

Disease-Free Survival24 months

Secondary

Complete Hematological Response24 weeks
Complete Cytogenetic Response24 weeks
Complete Molecular Response24 weeks
BCR-ABL Kinase Domain MutationsDuring and after study
Event-Free SurvivalEnd of study
Overall SurvivalEnd of study
Side Effects and Adverse EventsEnd of study

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