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A Dose Escalation Study of Duvortuxizumab in Participants With Relapsed or Refractory B-cell Malignancies

NCT02454270 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 59

Last updated 2018-12-20

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety, tolerability, dose-limiting toxicities (any harmful effect of a drug) (DLT), maximum tolerated dose (MTD), recommended Phase 2 dose (RP2D) and preliminary clinical activity of duvortuxizumab when administered intravenously to participants with relapsed or refractory B-cell malignancies \[diffuse-large B cell lymphoma (DLBCL), follicular lymphoma (FL), mantle-cell lymphoma (MCL), chronic lymphocytic leukemia (CLL), and acute lymphoblastic leukemia (ALL)\].

Conditions

  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Follicular
  • Lymphoma, Mantle-Cell
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

DRUG

Part 1 (Dose Escalation): Duvortuxizumab

Participants currently enrolled in the study will continue to receive duvortuxizumab every 14 days (biweekly dosing) in each 28 -day cycle as an intravenous infusion. In the priming dose regimen, a priming dose will be administered on Day 1 followed by full doses on Day 8 and Day 22, of a 35-day Cycle 1, and then every 14 days in each subsequent 28-day cycle. The cohorts will be opened where participants will receive duvortuxizumab every 7 days (for investigating weekly dosing schedule) in each 28-day cycle as an intravenous infusion. In the priming dose regimen, a priming dose will be administered on Day 1 followed by full doses on Day 8, Day 15, Day 22, and Day 28 of a 35-day Cycle 1, and then every 7 days in each subsequent 28-day cycle.

DRUG

Part 2 (Dose Expansion): Duvortuxizumab

Participants will receive intravenous infusion of duvortuxizumab at the recommended Phase 2 dose (RP2D) defined in Part 1 for their disease type either with or without a priming dose.

Sponsors & Collaborators

  • Janssen Research & Development, LLC

    lead INDUSTRY

Principal Investigators

  • Janssen Research & Development, LLC Clinical Trial · Janssen Research & Development, LLC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-06-15
Primary Completion
2018-07-26
Completion
2018-07-26

Countries

  • United States
  • Belgium
  • France
  • Israel
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02454270 on ClinicalTrials.gov