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

NCT02541565 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-10-14

Study results available
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Summary

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.

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

Interventions

DRUG

Cyclophosphamide

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Pembrolizumab

Given IV

DRUG

Prednisone

Given PO

BIOLOGICAL

Rituximab

Given IV

DRUG

Vincristine Sulfate

Given IV

Sponsors & Collaborators

Principal Investigators

  • Stephen Smith · Fred Hutch/University of Washington Cancer Consortium

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-24
Primary Completion
2018-12-18
Completion
2018-12-18
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT02541565 on ClinicalTrials.gov