Status and phase
Conditions
Treatments
About
The main purpose of this study to find the ideal dose for the combination treatment of Zanubrutinib and Tafasitamab in patients with mantle cell lymphoma. Another purpose is to assess how well the combination treatment works in patients with the study disease.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
Men and women ≥ 18 years of age
Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification
Baseline PET/CT scans must demonstrate fluorodeoxyglucose (FDG) avid lesions compatible with CT defined anatomical tumor sites. Patients should have at least one measurable site of disease per Lugano classification
Patient should have indication according to primary investigator for treatment initiation
Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
Life expectancy of greater than 4 months.
Willingness to avoid pregnancy or fathering children during the study and for at least 90 days after the last dose of the study drug.
Patients must have normal organ and marrow function as defined below:
Inclusion Criteria, Phase 1 Only:
Inclusion Criteria, Phase 2 Only:
Exclusion Criteria, Phase 1 and 2:
Primary purpose
Allocation
Interventional model
Masking
27 participants in 2 patient groups
Loading...
Central trial contact
Alvaro Alencar, MD
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal