Zanubrutinib and Tafasitamab in Mantle Cell Lymphoma
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.
| Condition(s) | Mantle Cell Lymphoma |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | Inclusion Criteria: 1. Men and women ≥ 18 years of age 2. Patients must have histologic confirmation of mantle cell lymphoma (MCL) defined by the World Health Organization (WHO) classification 3. 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 4. Patient should have indication according to primary investigator for treatment initiation 5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 6. Life expectancy of greater than 4 months. 7. Willingness to avoid pregnancy or fathering children during the study and for at least 90 days after the last dose of the study drug. 8. Patients must have normal organ and marrow |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Alvaro Alencar, MD |
| Locations | Miami, Florida, United States |
| Start date | 2024-05-03 |
| NCT ID | NCT06029309 |
| Official listing | https://clinicaltrials.gov/study/NCT06029309 |