A Study of Zilovertamab and Ibrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Megadott ok: Due to a strategic reprioritization based on the rapidly changing clinical and commercial landscape for Bruton's tyrosine kinase inhibitors (BTK inhibitors)
Key facts
- Phase
- 3. fázis
Trial details
- Who runs it
- Oncternal Therapeutics, Inc
- Trial code
- NCT05431179
- Record updated
- 2023. április 21.
- Original description
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).Read full original descriptionShow less
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).
Inclusion: Histologically confirmed MCL; Has received one prior regimen for MCL; Disease is relapsed or refractory; At least 1 measurable site of disease that is ≥ 2.0 cm; PET-CT performed less than 28 days before study entry; If a subject has toxicities due to prior therapy for the treatment of MCL, must be stable and recovered; Eastern Cooperative Oncology Group performance status of 0 or 1; Study-specific laboratory parameters must be met; Females of childbearing potential and males must use highly effective contraception.
Exclusion: Received more than one month of prior therapy with ibrutinib or any other Bruton's tyrosine kinase inhibitor; Concurrent enrollment in another investigational study; Anticancer therapy within 25 days before the start of the study; Active or prior cardiac (atrial or ventricular) lymphoma involvement; Prior stem cell transplant that requires ongoing immunosuppressive therapy or active clinical graft versus host disease; Vaccination with a live, attenuated vaccine ≤ 4 weeks of the start of the study; Requires treatment with a strong cytochrome P450 enzyme (CYP) 3A (CYP3A) inhibitor/inducer; Major surgery ≤ 4 weeks of study start; History of other malignancy, cancer, or carcinoma for at least three years before the start of the study; CNS disorder ≤ 6 months of study entry; History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, active arrhythmias, class 3 or 4 congestive heart failure, or other clinically significant cardiac disease ≤ 6 months of study entry; History of atrial fibrillation or left or right bundle branch block; History of symptomatic deep vein thrombosis or pulmonary embolism ≤ 6 months of study entry; Chronic liver disease with hepatic impairment, Child-Pugh class B or C; Bleeding disorder; Human immunodeficiency virus infection (HIV) or active hepatitis B or C infection; Active infection requiring IV antimicrobial (antiviral, antibiotic, anti-fungal) therapy at the time of study entry; Hypersensitivity reaction to any of the agents used in this study; Unable or swallow capsules or tablets or has malabsorption syndrome or disease affecting gastrointestinal function; Medical condition likely to interfere with assessment of safety or efficacy of the study drug; Transfusion-dependent thrombocytopenia; Central nervous system (CNS) involvement with lymphoma; Primary severe immunodeficiency; Not eligible in the opinion of the Investigator; Pregnant or breastfeeding; Other protocol-defined inclusion/exclusion criteria will apply.