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Phase II study of Polatuzumab vedotin in combination with chemotherapy in subjects with Richter’s Transformation

Clinical Trial Details

This clinical trial is for men and women with a diagnosis of chronic lymphocytic leukemia (CLL) and Richter’s transformation. Richter’s transformation occurs when CLL changes into a type of diffuse large B cell lymphoma (DLBCL).
   
The purpose of this study is to evaluate the safety and efficacy of the investigational drug, Polatuzumab vedotinin, in combination with a standard chemoimmunotherapy regimen.

An investigational drug means it has not been approved by the United States Food and Drug Administration (FDA). Polatuzumab vedotin is currently FDA approved in combination with bendamustine and rituximab for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL) after at least two prior therapies, but not for Richter’s transformation.
   
Participants will be admitted to the hospital for close monitoring while the study drug is being administered along with the standard chemotherapy. Participants will receive the study drug over the course of Days 1 through 5 and are required to take some concomitant medications to help prevent infection and diminish side effects.
   
Participants will be treated on this study for approximately 5 months with a follow-up period lasting about 6 months after treatment with the investigational drug concludes.

Key Eligibility: 
  1. Open to men and women above the age of 18 who have confirmed diagnosis of CLL with biopsy proven Richter's Transformation to a DLBCL subtype.
  2. Participants cannot have received prior therapy targeting Richter's transformation.

Detailed eligibility reviewed when participant contacts the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Victoria Mendez
212-746-4829
vib9049@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2008022533

ClinicalTrials.gov:

NCT04679012

Status

Open to Enrollment

Age Group

Adult

Sponsor