Phase 2 Study of Glofitamab Monotherapy & With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Christine Ryan
Study ID
NCT06043674
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Glofitamab — DRUG
    "2:1" T-cell bispecific humanized monoclonal antibody, administered via intravenous infusion per protocol.
  • Obinutuzumab — DRUG
    Humanized glycoengineered type II anti-CD20 monoclonal antibody, administered via intravenous infusion per protocol.
  • Polatuzumab Vedotin — DRUG
    Antibody-drug conjugate, administered via intravenous infusion per protocol.
  • Atezolizumab — DRUG
    Humanized immunoglobulin monoclonal antibody, administered via intravenous infusion per protocol.
  • Tocilizumab — DRUG
    For the treatment of Cytokine Release Syndrome. Recombinant, humanized, anti-human monoclonal antibody, administered via intravenous infusion per protocol.
  • Pirtobrutinib — DRUG
    Selective inhibitor of BTK, 50 mg or 100 mg tablet, via oral administration per protocol.

Study Details

This research is being done to evaluate Glofitamab by itself or in combination with Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab as possible treatments for Chronic Lymphocytic Leukemia (CLL) that has transformed into Richter's Transformation (RT). The names of the study drugs involved in this research study are: * Glofitamab (a T-cell bispecific humanized monoclonal antibody) * Obinutuzumab (a humanized glycoengineered type II anti-CD20 monoclonal antibody) * Polatuzumab vedotin (an antibody-drug conjugate) * Pirtobrutinib (a selective inhibitor of BTK) * Atezolizumab (a humanized immunoglobulin monoclonal antibody) * Tocilizumab (a recombinant, humanized, anti-human monoclonal antibody)

Key Dates

Start date
Jan 22, 2024
Status verified
Jan 2026
Primary completion
Jan 15, 2028
Completion
Jan 15, 2033

Study Design

Enrollment
70 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Monotherapy Cohort: Obinutuzumab and Glofitamab
    Study procedures will be conducted as follows: * Baseline visit with screening procedures, including bone marrow biopsy and Positron Emission Tomography (PET) or Computed Topography (CT) scans. * PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment. * Cycle 1: * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily. * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation. * Cycle 2 - 12 --Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for second dose and post-dose observation * End of treatment visit. * Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months. * After completion of a 10-patient safety lead-in cohort, enrollment will open to the other two cohorts.
  • Experimental: Combination A Group: Obinutuzumab, Glofitamab, and Polatuzumab Vedotin
    Study procedures will be conducted as follows: * Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans. * PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment. * Cycle 1: * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily. * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation. * Cycle 2 - 7: \- Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Polatuzumab Vedotin 1x daily. * Cycle 8 - 12 \- Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. * End of treatment visit. * Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months.
  • Experimental: Combination B Group: Obinutuzumab, Glofitamab, and Pirtobrutinib
    Study procedures will be conducted as follows: * Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans. * PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment. * Cycle 1: * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily. * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation. * Cycle 2 - 12 \- Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Pirtobrutinib 1x daily. Days 2-21 of each cycle: Pirtobrutinib will be taken once daily. * End of treatment visit. * Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months.
  • Experimental: Combination C Group: Obinutuzumab, Glofitamab, and Atezolizumab
    Study procedures will be conducted as follows: * Baseline visit with screening procedures, including bone marrow biopsy and PET/CT scans. * PET/CT scans after 4, 8, and 12 cycles of therapy and at 6 and 15 months after end-of-treatment. * Cycle 1: * Day 1, 2, and 7 of 21- day Cycle: Predetermined dose of Obinutuzumab 1x daily. * Day 8 and 15 of 21- day Cycle: Predetermined dose of Glofitamab 1x daily. Hospitalization will be required for initial dose and post-dose observation. * Cycle 2 - 12 \- Day 1 of 21-day Cycle: Predetermined dose of Glofitamab 1x daily. Predetermined dose of Atezolizumab 1x daily. * End of treatment visit. * Follow up visits: for months 10 - 24, visits will be every 3 months. For months 25 - 60 visits will be every 6 months.

Primary Outcome Measure

Best Complete Response (CR) Rate [ Time Frame: Disease evaluation will be performed at 12, 24 and 36 weeks ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
Winship Cancer Institute at Emory UniversityAtlantaGeorgia30322
Andres Chang, MD
[email protected]
Andres Chang, MD (PRINCIPAL_INVESTIGATOR)
Brigham and Women's HospitalBostonMassachusetts02215
DFCI Lymphoma Research Nurses
[email protected]
Christine Ryan, MD (PRINCIPAL_INVESTIGATOR)
Dana Farber Cancer InstituteBostonMassachusetts02215
DFCI Lymphoma Research Nurses
[email protected]
Christine Ryan, MD (PRINCIPAL_INVESTIGATOR)
The University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Deborah Stephens, DO
[email protected]
Deborah Stephens, DO (PRINCIPAL_INVESTIGATOR)
The Ohio State University Comprehensive Cancer CenterColumbusOhio43210
Kerry Rogers, MD
[email protected]
Kerry Rogers, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

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Winship Cancer Institute at Emory University· Atlanta, GABrigham and Women's Hospital· Boston, MADana Farber Cancer Institute· Boston, MAThe University of North Carolina at Chapel Hill· Chapel Hill, NCThe Ohio State University Comprehensive Cancer Center· Columbus, OH

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