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Monoclonal Antibodies

Glofitamab Combinations for Richter's Transformation

Phase 2

Recruiting

Led By Christine Ryan, MD

Research Sponsored by Christine Ryan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years.

ECOG performance status of 0-2 (Appendix A).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up participants will be followed up to 2 years.

Awards & highlights

Study Summary

This trial is researching new treatments for Chronic Lymphocytic Leukemia that has transformed into Richter's Transformation.

Who is the study for?

This trial is for adults over 18 with Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma that's turned into a more aggressive form called Richter's Transformation. They should have certain normal organ and blood cell levels, no severe recent treatments, and be willing to use effective birth control. Those who've had specific prior therapies or other cancers aren't eligible.Check my eligibility

What is being tested?

Researchers are testing Glofitamab alone or combined with Polatuzumab Vedotin or Atezolizumab as treatments for CLL/RT. These drugs include monoclonal antibodies targeting cancer cells in different ways, aiming to improve the body’s immune response against cancer.See study design

What are the potential side effects?

Potential side effects may include reactions at the infusion site, increased risk of infections due to immune system effects, liver function changes, and possibly others depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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My kidney function, measured by creatinine levels, is within normal limits.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be followed up to 2 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be followed up to 2 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed up to 2 years. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Best Complete Response (CR) Rate

Secondary outcome measures

Best Overall Response Rate (ORR)

Best Partial Response (PR) Rate

Complete Response (CR) Rate at 36 weeks

+15 more

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Combination B Group: Obinutuzumab, Glofitamab,and AtezolizumabExperimental Treatment4 Interventions

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.

Group II: Combination A Group: Obinutuzumab, Glofitamab, and Polatuzumab VedotinExperimental Treatment4 Interventions

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.

Group III: Monotherapy Cohort: Obinutuzumab and GlofitamabActive Control3 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tocilizumab

2012

Completed Phase 4

~1840

Glofitamab

2021

Completed Phase 1

~60

Atezolizumab

2017

Completed Phase 3

~5860

Polatuzumab Vedotin

2019

Completed Phase 2

~820

Obinutuzumab

2015

Completed Phase 3

~3250

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Christine RyanLead Sponsor

Matthew S. Davids, MDLead Sponsor

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

568,077 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there still opportunities to join this experiment?

"Clinicaltrials.gov does not list this study as an active trial, with the initial posting occurring on October 1st 2023 and the final modification taking place September 12th 2023. However, there are currently 670 different clinical trials presently recruiting patients."

Answered by AI

Has the administration given regulatory approval to the trio of Obinutuzumab, Glofitamab, and Polatuzumab Vedotin (Combination A Group)?

"The aggregate safety score of Combination A Group: Obinutuzumab, Glofitamab, and Polatuzumab Vedotin was judged to be a 2 due the absence of prior efficacy data but available information on its safety profile."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Ph 2 Study of Glofitamab Alone or in Combination With Polatuzumab Vedotin or Atezolizumab in Richter's Transformation

Christine Ryan 2024. "A Ph 2 Study of Glofitamab Alone or in Combination With Polatuzumab Vedotin or Atezolizumab in Richter's Transformation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06043674.