Pembrolizumab and Combination Chemotherapy in Treating Patients With Previously Untreated Diffuse Large B-cell Lymphoma or Grade 3b Follicular Lymphoma

Part of paid clinical trials in Seattle, Washington.

Sponsor
University of Washington
Study ID
NCT02541565
Phase
PHASE1
Status
Completed

Conditions

  • Composite Lymphoma
  • Grade 3b Follicular Lymphoma
  • Stage I Diffuse Large B-Cell Lymphoma
  • Stage I Follicular Lymphoma
  • Stage II Diffuse Large B-Cell Lymphoma
  • Stage II Follicular Lymphoma
  • Stage III Diffuse Large B-Cell Lymphoma
  • Stage III Follicular Lymphoma
  • Stage IV Diffuse Large B-Cell Lymphoma
  • Stage IV Follicular Lymphoma

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pembrolizumab — BIOLOGICAL
    Given IV
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

This pilot phase I trial studies the side effects of pembrolizumab and combination chemotherapy in treating patients with previously untreated diffuse large B-cell lymphoma or grade 3b follicular lymphoma. Monoclonal antibodies, such as pembrolizumab and rituximab, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, 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 pembrolizumab together with combination chemotherapy may be with a better treatment for diffuse large B-cell lymphoma or follicular lymphoma.

Key Dates

Start date
Nov 24, 2015
Status verified
Aug 2020
Primary completion
Dec 18, 2018
Completion
Dec 18, 2018

Study Design

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

Arms

  • Experimental: Treatment (pembrolizumab, combination chemotherapy)
    Patients receive pembrolizumab IV over 30 minutes on day 1 and prednisone PO on days 1-5. Patients also receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV, and vincristine sulfate IV on day 2 of course 1 and on day 1 of subsequent courses. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With a Grade 3 or Higher Toxicity Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0 [ Time Frame: Up to 90 days after completion of study treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Fred Hutch/University of Washington Cancer ConsortiumSeattleWashington98109-

Find similar trials in Seattle, WA

By research site
Fred Hutch/University of Washington Cancer Consortium· Seattle, WA

Related Studies