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Polatuzumab Vedotin and Combination Chemotherapy for the Treatment of Previously Untreated Lymphoma

NCT04479267 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2025-09-29

No results posted yet for this study

Summary

This phase II trial studies how well polatuzumab vedotin and combination chemotherapy work in treating patients with previously untreated double, triple hit lymphoma, Double Expressor Lymphoma or High-Grade B Cell Lymphoma. Polatuzumab vedotin is a monoclonal antibody that works by binding with cancer cells and releasing another chemotherapy drug, called monomethyl auristatin E, into the cell causing the cancer cells to die or stop growing. Chemotherapy drugs, such as rituximab, cyclophosphamide, doxorubicin, and prednisone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving polatuzumab vedotin with combination chemotherapy may work better in treating patients with double or triple hit lymphoma compared to combination chemotherapy alone.

Conditions

  • Diffuse Large B-Cell Lymphoma
  • High Grade B-Cell Lymphoma w/MYC & BCL2 or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma w/MYC, BCL2 & BCL6 Rearrangements
  • Double Expressor Lymphoma
  • High-grade B-cell Lymphoma

Interventions

DRUG

Prednisone

Given PO

DRUG

Prednisolone

Given IV

DRUG

Methylprednisolone

Given IV

BIOLOGICAL

Rituximab

Given IV

DRUG

Polatuzumab Vedotin

Given IV

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Barbara Ann Karmanos Cancer Institute

    lead OTHER

Principal Investigators

  • Dipenkumar Modi, M.D. · Barbara Ann Karmanos Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-21
Primary Completion
2025-06-19
Completion
2026-07-19
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04479267 on ClinicalTrials.gov