Phase II Study of Combined Pirtobrutinib, Venetoclax and Obinutuzumab (PVO) Time-limited Treatment for Patients With Recurrent Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL).
Part of paid clinical trials in Houston, Texas.
- Sponsor
- M.D. Anderson Cancer Center
- Study ID
- NCT06967610
- Phase
- PHASE2
- Status
- Recruiting
Conditions
- Chronic Lymphocytic Leukemia
- Small Lymphocytic Leukemia (SLL)
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Pirtobrutinib — DRUGGiven PO 200mg daily
- Venetoclax — DRUGGiven PO daily
- Obinutuzumab — DRUGGiven IV 100mg day 1, 900 mg day 2, 100mg days 8, 15
Study Details
To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.
Key Dates
- Start date
- Jul 15, 2025
- Status verified
- Nov 2025
- Primary completion
- Jun 1, 2031
- Completion
- Jun 1, 2033
Study Design
- Enrollment
- 40 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: V-ExposedVenetoclax Exposed: Treatment with Pirtobrutinib+Venetoclax+Obinutuzumab Q4W
- Experimental: V-NaiveVenetoclax Naive: Treatment with Pirtobrutinib+Venetoclax+Obinutuzumab Q4W
Primary Outcome Measure
Safety and adverse events [ Time Frame: Through study completion; an average of 1 year. ]
Central Contacts
- Alessandra Ferrajoli, MD713-792-2063
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| MD Anderson Cancer Center | Houston | Texas | 77030 | Alessandra Ferrajoli, MD (PRINCIPAL_INVESTIGATOR) |
Find similar trials in Houston, TX
By condition
By specialty
By research site
Related Studies
- A Long-term Extension Study of PCI-32765 (Ibrutinib)PHASE3 · Recruiting · Janssen Research & Development, LLC · Duarte, California
- Activated T-Cells Expressing 2nd or 3rd Generation CD19-Specific CAR, Advanced B-Cell NHL, ALL, and CLL (SAGAN)PHASE1 · Recruiting · Baylor College of Medicine · Houston, Texas
- Venetoclax With Ibrutinib or Acalabrutinib in Pts. With High-risk CLLPHASE2 · Recruiting · M.D. Anderson Cancer Center · Houston, Texas
- Dose-escalation and Dose-expansion Study of Safety of Azer-cel (PBCAR0191) in Participants With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL)PHASE1 · Recruiting · Imugene Limited · Gilbert, Arizona