Fixed Duration Pirtobrutinib and Obinutuzumab in Chronic Lymphocytic Leukemia

Part of paid clinical trials in Scarborough, Maine.

Sponsor
Inhye Ahn
Study ID
NCT06333262
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Pirtobrutinib — DRUG
    Initial treatment: \- Pirtobrutinib 200 mg by mouth (PO) daily from Cycle 1 Day 1 until the end of Cycle 12. Each cycle is 28 days. Re-treatment: -Pirtobrutinib 200 mg PO daily continuously
  • Obinutuzumab — DRUG
    Obinutuzumab is given intravenously from Cycle 7 to Cycle 12, for total 6 cycles during initial treatment only. Initial treatment: \- Obinutuzumab intravenous (IV) following the standard schedule from Cycle 6 through Cycle 12 (total 6 cycles: 100 mg on Cycle 6 Day 1, 900 mg on Cycle 6 Day 2, 1000 mg on Cycle 6 Day 8 and Cycle 6 Day 15, 1000 mg on Day 1 of Cycle 7 through Cycle 12).

Study Details

This study will evaluate fixed-duration therapy with pirtobrutinib and obinutuzumab given over 12 cycles (approximately 1 year) as first-line treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma (CLL or SLL).

Key Dates

Start date
Apr 22, 2024
Status verified
Jan 2026
Primary completion
Jul 1, 2027
Completion
Jul 1, 2032

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Pirtobrutinib-Obinutuzumab
    Eligible participants will receive initial treatment with pirtobrutinib and obinutuzumab for 12 cycles. Participants with progressive chronic lymphocytuc leukemia or small lymphocytic lymphoma during the off-treatment follow-up will receive continuous pirtobrutinib monotherapy.

Primary Outcome Measure

Rate of complete response after initial therapy [ Time Frame: 1 year since treatment initiation ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
New England Cancer SpecialistsScarboroughMaine04074
Cindy Taylor
[email protected]
207-303-3420
John P Winters, III, MD (PRINCIPAL_INVESTIGATOR)
Beth Israel Deaconess Medical CenterBostonMassachusetts02215
Jon Arnason, MD
Jon Arnason, MD (PRINCIPAL_INVESTIGATOR)
Brigham & Women's HospitalBostonMassachusetts02215
Inhye Ahn
Inhye Ahn, MD (PRINCIPAL_INVESTIGATOR)
Dana-Farber Cancer InstituteBostonMassachusetts02215
Megan Forsyth
[email protected]
857-215-1405
Inhye Ahn, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Scarborough, ME

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
New England Cancer Specialists· Scarborough, MEBeth Israel Deaconess Medical Center· Boston, MABrigham & Women's Hospital· Boston, MADana-Farber Cancer Institute· Boston, MA

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