Status:
WITHDRAWN
A Study of Zilovertamab and Ibrutinib in Patients With Relapsed or Refractory Mantle Cell Lymphoma
Lead Sponsor:
Oncternal Therapeutics, Inc
Collaborating Sponsors:
Pharmacyclics LLC.
Conditions:
Lymphoma, Mantle-Cell
Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 cel...
Detailed Description
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that will be conducted in multiple phases in patients with R/R MCL. The study phases will include a Screening Phase, ...
Eligibility Criteria
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
- Transfusion-dependent thrombocytopenia
- Anticancer therapy within 25 days before the start of the study
- History of other malignancy, cancer, or carcinoma for at least three years before the start of the study
- Central nervous system (CNS) involvement with lymphoma
- 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
- Active or prior cardiac (atrial or ventricular) lymphoma involvement
- 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
- Prior stem cell transplant that requires ongoing immunosuppressive therapy or active clinical graft versus host disease
- Primary severe immunodeficiency
- 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
- Vaccination with a live, attenuated vaccine ≤ 4 weeks of the start of the study
- Hypersensitivity reaction to any of the agents used in this study
- Requires treatment with a strong cytochrome P450 enzyme (CYP) 3A (CYP3A) inhibitor/inducer.
- Unable or swallow capsules or tablets or has malabsorption syndrome or disease affecting gastrointestinal function
- Major surgery ≤ 4 weeks of study start
- Medical condition likely to interfere with assessment of safety or efficacy of the study drug
- Not eligible in the opinion of the Investigator
- Pregnant or breastfeeding
- Other protocol-defined inclusion/exclusion criteria will apply.
Key Trial Info
Start Date :
March 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT05431179
Start Date
March 1 2023
End Date
December 1 2026
Last Update
April 21 2023
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.