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A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Zilovertamab (an ROR1 Antibody) Plus Ibrutinib Versus Ibrutinib Plus Placebo in Subjects With Relapsed or Refractory Mantle Cell Lymphoma
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).
Details
| Lead sponsor | Oncternal Therapeutics, Inc |
|---|---|
| Phase | Phase 3 |
| Status | WITHDRAWN |
| Start date | 2023-03 |
| Completion | 2026-12 |
Conditions
- Lymphoma, Mantle-Cell
- Lymphoma
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Immune System Diseases
- Lymphoma, Non-Hodgkin
- Lymphoma, B-Cell
Interventions
- Zilovertamab
- Ibrutinib
- Placebo
Primary outcomes
- Progression-free survival (PFS) — Approximately 2 years
PFS as assessed by Blinded Independent Central Review (BICR) per Lugano Classification is superior for ibrutinib plus zilovertamab compared to ibrutinib plus placebo among subjects with relapsed or refractory (R/R) mantle cell lymphoma (MCL) that had a PR or SD after 16 weeks of ibrutinib monotherapy.