A Study of Zilovertamab and Ibrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma

Sponsor
Oncternal Therapeutics, Inc
Study ID
NCT05431179
Phase
PHASE3
Status
Withdrawn

Conditions

  • Immune System Diseases
  • Immunoproliferative Disorders
  • Lymphatic Diseases
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Mantle-Cell
  • Lymphoma, Non-Hodgkin
  • Lymphoproliferative Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Zilovertamab — DRUG
    After 16 weeks in the open-label Ibrutinib phase, participants will receive zilovertamab (600mg) administered by IV every 2 weeks for 3 administrations and then every 4 weeks thereafter.
  • Ibrutinib — DRUG
    All participants will receive oral Ibrutinib (560mg) daily.
  • Placebo — DRUG
    After 16 weeks in the open-label Ibrutinib phase, participants will receive placebo administered by IV every 2 weeks for 3 administrations and then every 4 weeks thereafter.

Study Details

This is a Phase 3 study to investigate the safety and efficacy of the investigational drug, zilovertamab, when given in combination with ibrutinib in patients with relapsed/refractory (R/R) mantle cell lymphoma (MCL).

Key Dates

First listed
Jun 24, 2022
Start date
Mar 31, 2023
Status verified
Apr 2023
Primary completion
Nov 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Oral Ibrutinib
    Open Label Ibrutinib Monotherapy Phase (16 weeks)
  • Experimental: Arm A: IV Infusion of Ziloveramab and Oral Ibrutinib
    Randomized, Double-Blind Treatment Phase
  • Placebo Comparator: Arm B: IV Infusion of Placebo and Oral Ibrutinib
    Randomized, Double-Blind Treatment Phase

Primary Outcome Measure

Progression-free survival (PFS) [ Time Frame: Approximately 2 years ]

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