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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).

Must not have

Patients with the Hodgkin variant transformation of CLL will be excluded.

Patients with bulky cervical adenopathy that is compressing the upper airway and could result in significant further airway compression during a tumor flare event.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up within the first year on study

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My condition is not Hodgkin variant transformation of CLL.

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I have large neck lymph nodes affecting my breathing.

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I have not had CAR T-cell therapy in the last 30 days.

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I have not received treatments with anti-CD20, polatuzumab vedotin, or atezolizumab.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ participants will be followed up to 10 years.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~participants will be followed up to 10 years.

This trial's timeline: 3 weeks for screening, Varies for treatment, and participants will be followed up to 10 years. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best Complete Response (CR) Rate

Secondary study objectives

Best Overall Response Rate (ORR)

Best Partial Response (PR) Rate

Complete Response (CR) Rate at 36 weeks

+15 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Atezolizumab

2016

Completed Phase 3

~5860

Tocilizumab

2012

Completed Phase 4

~1840