Trial intelligence / Profile preview

HQP1351 in T315I-Mutated CML-AP

NCT03883100Phase 2

Key facts

Status: Unknown
Start: Apr 2019
Primary completion: Apr 2024
Countries: 1
Sponsor: Ascentage Pharma
Modality: Small Molecules

Drugs: olverembatinib
Conditions: chronic myeloid leukemia (CML)

Overview

Phase 2, open-label, single-arm trial of olverembatinib in chronic myeloid leukemia (CML), sponsored by Ascentage Pharma. Primary endpoint: Major Hematologic Response. Status: unknown.

Design

1 arm

Study design: Non-randomizedOpen-label

HQP1351 Arm
Single arm receiving Olverembatinib (HQP1351)

Who it enrols

Patients with CML-AP harboring the T315I mutation who have received prior TKI treatment.

Endpoints

Primary

Major Hematologic ResponseUp to 24 cycles

Secondary

Complete Hematologic ResponseUp to 24 cycles
Major Cytogenetic ResponseUp to 24 cycles
Complete Cytogenetic ResponseUp to 24 cycles
Major Molecular ResponseUp to 24 cycles
Time to ResponseUp to 24 cycles
Duration of ResponseUp to 24 cycles
Progression-Free SurvivalUp to 24 cycles
Overall SurvivalUp to 24 cycles

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