Trial intelligence / Profile preview

DA-EPOCH-A for Adults with ALL/Lymphoblastic Lymphoma

NCT02538926Phase 2

Key facts

Status: Withdrawn
Start: Jul 2018
Primary completion: Jul 2020
Countries: 1
Sponsor: University of Washington
Modality: Replacement Enzymes

Drugs: asparaginase escherichia coli
Conditions: acute lymphoblastic leukemia (ALL)lymphoblastic lymphoma (LL)

Overview

Phase 2, open-label, single-arm trial of asparaginase escherichia coli in acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LL), sponsored by University of Washington. Primary endpoints: Complete minimal residual disease response rate up to 5 years, Overall response rate up to 5 years and 2 more. Planned start Jul 2018; status: withdrawn.

Design

1 arm

Study design: Non-randomizedOpen-label

Treatment (DA-EPOCH-A)
DA-EPOCH-A chemotherapy regimen +/- Rituximab +/- Imatinib

Who it enrols

Adult patients with confirmed B- or T-cell ALL or lymphoblastic lymphoma, either initially diagnosed at age 40 or later (Arm A) or relapsed/refractory (Arm B).

Endpoints

Primary

Complete minimal residual disease response rateUp to 5 years
Overall response rateUp to 5 years
Overall survivalUp to 5 years
Progression-free survivalUp to 5 years

Secondary

Incidence of adverse eventsUp to 30 days post-treatment

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