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).

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center

About this trial

To learn if the drug combination pirtobrutinib, venetoclax, and obinutuzumab can help to control relapsed CLL/SLL.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18 years or older.

Diagnosis of CLL/SLL per 2018 iwCLL criteria (See Appendix 1).

Participants with previously treated CLL requiring therapy based on 2018 iwCLL criteria.

The participant is able to take oral medications.

Disqualifiers

Participants who experienced progression of disease according to 2018 iwCLL criteria while on venetoclax will be excluded.

Patient with prior history of Richter's syndrome or current Richter's Syndrome.

Participants with known hypersensitivity to any of the excipients of pirtobrutinib, venetoclax,obinutuzumab or to any intended study medications.

Known or suspected history of central nervous system (CNS) involvement by CLL/SLL.

Trial design

Design model

Single group

Treatments tested in this trial

  • Pirtobrutinib

    Drug

    Given PO 200mg daily

  • Venetoclax

    Drug

    Given PO daily

  • Obinutuzumab

    Drug

    Given IV 100mg day 1, 900 mg day 2, 100mg days 8, 15

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: V-ExposedExperimental treatment 3 interventions
Group B: V-NaiveExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Safety and adverse events

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5

Time frame
Through study completion; an average of 1 year.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

Eli Lilly and Company

Collaborator