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

Part of paid clinical trials in Detroit, Michigan.

Sponsor
Barbara Ann Karmanos Cancer Institute
Study ID
NCT04479267
Phase
PHASE2
Status
Active Not Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    Given PO
  • Prednisolone — DRUG
    Given IV
  • Methylprednisolone — DRUG
    Given IV
  • Rituximab — BIOLOGICAL
    Given IV
  • Polatuzumab Vedotin — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Aug 21, 2020
Status verified
Sep 2025
Primary completion
Jun 19, 2025
Completion
Jul 19, 2026

Study Design

Enrollment
8 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (polatuzumab vedotin, R-CHP)
    Patients receive prednisone PO, prednisolone IV, or methylprednisolone IV on days 1-5. Patients also receive rituximab IV, polatuzumab vedotin IV over 30-90 minutes, cyclophosphamide IV, and doxorubicin hydrochloride IV on day 1. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Rate of complete remission [ Time Frame: Up to 6-8 weeks after cycle 6 day 1 (cycles = 21 days) or last dose of study medication ]

Locations (1)

FacilityCityStateZIPSite coordinators
Karmanos Cancer InstituteDetroitMichigan48201-

Find similar trials in Detroit, MI

By research site
Karmanos Cancer Institute· Detroit, MI

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