Trial intelligence / Profile preview

Motixafortide + Nelarabine in R/R T-ALL/LBL

NCT02763384Phase 2

Key facts

Status: Terminated
Start: Dec 2016
Primary completion: Feb 2022
Countries: 1
Sponsor: Washington University School of Medicine
Modality: Peptides

Drugs: motixafortide
Conditions: t-cell acute lymphoblastic leukemia (T-ALL)T cell lymphoblastic lymphoma (T-LBL)

Overview

Phase 2, open-label, single-arm trial of motixafortide in t-cell acute lymphoblastic leukemia (T-ALL) and T cell lymphoblastic lymphoma (T-LBL), sponsored by Washington University School of Medicine. Primary endpoint: Number of Participants With Adverse Events. Started Dec 2016; status: terminated.

Design

1 arm

Study design: Non-randomizedOpen-label

Arm 1: BL-8040 and Nelarabine
BL-8040 subcutaneous daily + Nelarabine IV

Who it enrols

Adult patients with relapsed or refractory T-ALL or T-LBL, ECOG <= 2, adequate organ function, and no prior nelarabine treatment.

Endpoints

Primary

Number of Participants With Adverse EventsUp to 30 days after completion

Secondary

Composite Complete Remission Rate (CRc=CR+CRi)12 weeks
Overall Response Rate (CR, CRi + PR)Through completion of treatment
Time to ResponseThrough completion of treatment
Duration of ResponseUp to 2 years
Event-free SurvivalUp to 2 years
Overall SurvivalUp to 2 years
Rate of Patients Who Proceed to alloHCT After TreatmentThrough completion of treatment

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