Phase 2 Study of Glofitamab Alone or with Polatuzumab Vedotin or Atezolizumab for Treating Richter's Transformation

Sponsor: Christine Ryan

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT06043674

Provider View

This clinical trial is exploring the use of Glofitamab, either by itself or combined with Polatuzumab Vedotin or Atezolizumab, as a treatment for Chronic Lymphocytic Leukemia (CLL) that has changed into a more aggressive form called Richter's Transformation.

Patient Parameters

Program Overview

The study is testing whether Glofitamab, alone or with other drugs like Polatuzumab Vedotin or Atezolizumab, can be effective in treating a type of cancer called Richter's Transformation, which develops from Chronic Lymphocytic Leukemia (CLL). The drugs being studied include Glofitamab, Obinutuzumab, Polatuzumab Vedotin, Atezolizumab, and Tocilizumab. These drugs are not yet approved for this specific condition but are approved for other uses.

Description

This is a Phase II study to see how well Glofitamab works alone or with Polatuzumab Vedotin or Atezolizumab in people with Richter's Transformation, a condition that arises from Chronic Lymphocytic Leukemia (CLL). While these drugs are not approved for this specific condition, they are approved for other uses. Glofitamab is approved for a similar condition called diffuse large B-cell lymphoma (DLBCL).

Participants will undergo various procedures, including blood and urine tests, scans, and heart tests. The treatment will last about 9 months, with follow-up visits every 3-6 months for up to 10 years. Around 66 people are expected to join this study, which is funded by Genentech, Inc.

Eligibility Criteria

Inclusion Criteria

  • Must have a confirmed diagnosis of Chronic Lymphocytic Leukemia (CLL) that has transformed into a more aggressive form called Richter's Transformation.
  • Must be 18 years or older.
  • Must have good overall health with an ECOG performance status of 0-2.
  • Must have adequate organ and bone marrow function as determined by specific blood tests.
  • Must agree to use effective birth control during the study and for a specified time after treatment.
  • Must be willing to sign a consent form and understand the study requirements.

Exclusion Criteria

  • Cannot have a different type of transformation called Hodgkin variant.
  • Cannot have received certain treatments like anti-CD20 bispecific antibodies, Polatuzumab Vedotin, or Atezolizumab before.
  • Cannot have had certain treatments within 14 days before starting the study.
  • Cannot have had CAR T-cell therapy within 30 days before starting the study.
  • Cannot have unresolved side effects from previous cancer treatments.
  • Cannot have certain medical conditions like severe heart disease, active infections, or autoimmune diseases.
  • Cannot be pregnant or breastfeeding.
  • Cannot have received live vaccines within 28 days before starting the study.

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