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Withdrawn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

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 ]

Related Studies