Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05943496 | Tafasitamab, Acalabrutinib, and Obinutuzumab for the Treatment of Previously Untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma | PHASE1 | RECRUITING | 27 | — | — | Oct 2, 2023 | Jan 1, 2028 | Nov 6, 2025 | 1 | United States |
Incidences of DLTs, serious AEs, and AEs of special interest experienced during cycle 2-6 evaluated. The severity of the AE assessed using National Cancer Institute Common Terminology Criteria for Adverse Events version 5. The international working chronic lymphocytic leukemia (iwCLL) grading system for hematological toxicities also utilized. Incidence and type of DLT reported.
MRD negativity in patients reported using the efficacy set. Point estimate, along with exact two-sided 95% confidence interval (CI) reported.
| Arm | Type | Description |
|---|---|---|
| Treatment (tafasitamab, obinutuzumab, acalabrutinib) | EXPERIMENTAL | See Detailed DescriptionPatients receive obinutuzumab IV over a rate titrated up to 400 mg/hour on days 1, 2, 8, and 15 for cycle 1 then on day 1 for cycles 2-6 and tafasitamab IV over 1.5-2 hours on days 1, 4, 8, 15, and 22 for cycle 2, on days 1, 8, 15, and 22 for cycles 3-4, and on days 1 and 15 for cycles 5-7. Patients also receive acalabrutinib PO BID in each cycle. Treatment repeats every 28 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection and CT throughout the trial. Patients may undergo an ECHO at baseline as clinically indicated and may also undergo bone marrow biopsy and/or aspiration at baseline and/or follow-up. |
| Name | Type | Description |
|---|---|---|
| Acalabrutinib | DRUG | Given PO |
| Biospecimen Collection | PROCEDURE | Undergo blood sample collection |
| Bone Marrow Aspiration | PROCEDURE | Undergo bone marrow biopsy and/or aspiration |
| Bone Marrow Biopsy | PROCEDURE | Undergo bone marrow biopsy and/or aspiration |
| Computed Tomography | PROCEDURE | Undergo CT scan |
| Echocardiography | PROCEDURE | Undergo ECHO |
| Obinutuzumab | BIOLOGICAL | Given IV |
| Questionnaire Administration | OTHER | Ancillary studies |
| Tafasitamab | BIOLOGICAL | Given IV |
Participant Inclusion Criteria * Written informed consent. Participant or legally authorized representative (LAR) must provide written informed consent prior to any study-specific procedures or interventions * Age \>= 18 years. All genders, races, and ethnic groups will be included * Ability to swa...