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Denintuzumab Mafodotin (SGN-CD19A) Combined With RCHOP or RCHP Versus RCHOP Alone in Diffuse Large B-Cell Lymphoma or Follicular Lymphoma

NCT02855359 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-03-11

Study results available
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Summary

This is a Phase 2 study to evaluate the combination of denintuzumab mafodotin in combination with RCHOP or RCHP compared with RCHOP alone as front-line therapy in patients with diffuse large B-cell lymphoma or follicular lymphoma Grade 3b.

Conditions

  • Diffuse, Large B-Cell, Lymphoma
  • Follicular Lymphoma, Grade 3b
  • Transformed Lymphoma / DLBCL

Interventions

DRUG

denintuzumab mafodotin

SGN-CD19A at 3 mg/kg will be administered every 6 weeks via intravenous (IV) infusion, up to a maximum of three (3) doses, on Day 1 of Cycles 1, 3, and 5 of 21-day cycles

DRUG

rituximab

375 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

DRUG

cyclophosphamide

750 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

DRUG

doxorubicin

50 mg/m2 every 3 weeks by IV infusion for up to 6 cycles

DRUG

vincristine

1.4 mg/m2 every 3 weeks by IV infusion for up to 6 cycles (dose capped at 2 mg total)

DRUG

prednisone

100 mg on Days 1 to 5 of each 3-week cycle, orally for up to 6 cycles

Sponsors & Collaborators

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Juan Pinelli, PA-C, MMSc. · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-08-31
Primary Completion
2018-01-31
Completion
2018-05-15

Countries

  • United States
  • Puerto Rico

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 NCT02855359 on ClinicalTrials.gov