NCT06043674 · Christine Ryan
A Ph2 Study of Glofitamab Alone or With Polatuzumab Vedotin, Pirtobrutinib, or Atezolizumab in Richter's Transformation
What this study is about
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).
View original scientific description
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).
Interventions
DRUG
Glofitamab
"2:1" T-cell bispecific humanized monoclonal antibody, administered via intravenous infusion per protocol.
DRUG
Obinutuzumab
Humanized glycoengineered type II anti-CD20 monoclonal antibody, administered via intravenous infusion per protocol.
DRUG
Polatuzumab Vedotin
Antibody-drug conjugate, administered via intravenous infusion per protocol.
DRUG
Atezolizumab
Humanized immunoglobulin monoclonal antibody, administered via intravenous infusion per protocol.
DRUG
Tocilizumab
For the treatment of Cytokine Release Syndrome. Recombinant, humanized, anti-human monoclonal antibody, administered via intravenous infusion per protocol.
DRUG
Pirtobrutinib
Selective inhibitor of BTK, 50 mg or 100 mg tablet, via oral administration per protocol.
Primary outcome measures
Best Complete Response (CR) Rate
Time frame: Disease evaluation will be performed at 12, 24 and 36 weeks
Best Complete Response (CR) rate is defined as the proportion of participants achieving CR at any of the 3 timepoints (after 4, 8 and 12 cycles). CR is defined per Lugano 2014 criteria.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Must have a confirmed diagnosis of chronic lymphocytic leukemia or small lymphocytic lymphoma as per IW-CLL 2018 criteria with biopsy proven transformation to diffuse large B-cell lymphoma (DLBCL), consistent with Richter's Transformation. The diagnostic sample must be reviewed by the treating institution. Tumor sample may be obtained by core needle or excisional surgical biopsy. A fresh biopsy is encouraged, but an archival sample is acceptable if the following provisions are met: 1) availability of a tumor-containing formalin-fixed, paraffin-embedded (FFPE) tissue block, 2) if the tumor containing FFPE tissue block cannot be provided in total, sections from this block should be provided. Biopsy can be obtained up to 3 months prior to first day of treatment.
- Cohort-specific eligibility criteria:
- Glofitamab monotherapy cohort: Patients with either relapsed/refractory or previously untreated Richter's Transformation.
- Glofitamab + polatuzumab vedotin coh
Where
- Atlanta, Georgia
- Boston, Massachusetts
- Chapel Hill, North Carolina
- Columbus, Ohio
Collaborators
Genentech, Inc., Loxo Oncology, Inc., Eli Lilly and Company
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 7, 2026 · Source of record for eligibility and locations