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Treatment Study of Denintuzumab Mafodotin (SGN-CD19A) Plus RICE Versus RICE Alone for Diffuse Large B-Cell Lymphoma

NCT02592876 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2019-05-17

Study results available
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Summary

The purpose of this randomized, open-label study is to evaluate the safety and efficacy of denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be candidates for autologous stem cell transplant. Patients will be randomly assigned in a 1:1 ratio to receive 3 cycles of study treatment with either denintuzumab mafodotin + RICE or RICE alone. The study will assess whether there is a difference between the 2 groups in the side effects that are reported and the number of patients who achieve complete remission at the end of their study treatment.

Conditions

  • Lymphoma, B-cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Follicular, Grade 3b
  • Follicular Lymphoma, Grade 3b

Interventions

DRUG

denintuzumab mafodotin

Denintuzumab mafodotin 3 mg/kg by intravenous (IV) infusion, every 3 weeks for up to 3 cycles.

DRUG

rituximab

375 mg/m\^2 by IV infusion, every 3 weeks for up to 3 cycles

DRUG

ifosfamide

5000 mg/m\^2 by IV infusion over a 24-hour period, every 3 weeks for up to 3 cycles

DRUG

carboplatin

AUC 5mg/mL x min by IV infusion, every 3 weeks for up to 3 cycles

DRUG

etoposide

100 mg/m\^2 per day by IV infusion for 3 days, every 3 weeks for up to 3 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
2015-10-31
Primary Completion
2018-04-20
Completion
2018-04-20

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 NCT02592876 on ClinicalTrials.gov