CAP-100 for Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia
Introduction of immuno-chemotherapy in the treatment options of CLL and SLL changed the treatment paradigm of these diseases. Presently, first-line therapies for CLL/SLL include targeted therapies (e.g. ibrutinib, acalabrutinib) or combined immuno-chemotherapy regimens (e.g., fludarabine, cyclophosphamide, and rituxima
| Condition(s) | Lymphocytic Leukemia, Chronic, SLL |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | Introduction of immuno-chemotherapy in the treatment options of CLL and SLL changed the treatment paradigm of these diseases. Presently, first-line therapies for CLL/SLL include targeted therapies (e.g. ibrutinib, acalabrutinib) or combined immuno-chemotherapy regimens (e.g., fludarabine, cyclophosphamide, and rituximab for patients aged \<65 years without del17p/TP53 mutations or bendamustine and rituximab for patients ≥65 years who have additional comorbidities). Despite the gradual introduction of targeted therapies, new treatment strategies efficacious for patients ineligible for/unresponsive to these therapies are still required. These new strategies should ideally overcome disease relapse and circumvent compound-specific safety challenges. Emerging treatment options include new compo |
| Who can participate | Inclusion Criteria: 1. Age ≥ 18 years. 2. Able to understand and sign a written informed consent document. 3. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2. 4. Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL (USA). Relapsed or refractory to at least two (2) prior standard systemic treatment regimen for CLL or SLL and without available therapies known to provide clinical benefit (until new amendment implemented, Spain). 5. Prior CLL or SLL systemic therapy must have been discontinued for a duration of at least five times its half-life (palliative low dose steroids are allowed to bridge the time to CAP-100; major surgery or irradiation for CLL must have been completed \> 4 weeks prior to the first trial dose of medi |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Catapult Therapeutics |
| Locations | Boston, Massachusetts, United States; Durham, North Carolina, United States; Madrid, Spain; Santander, Spain |
| Start date | 2021-09-10 |
| NCT ID | NCT04704323 |
| Official listing | https://clinicaltrials.gov/study/NCT04704323 |