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A Randomized Phase IIb Placebo-Controlled Study of R-ICE Chemotherapy With and Without SGN-40 for Patients With DLBCL

NCT00529503 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 151

Last updated 2015-02-25

No results posted yet for this study

Summary

This is a randomized trial to estimate the activity of R-ICE plus SGN-40 vs. R-ICE plus placebo in patients with DLBCL. The study will assess safety and tolerability and will measure any additional clinical benefit observed in patients receiving SGN-40.

Conditions

  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin

Interventions

DRUG

SGN-40

2-8 mg/kg IV. Cycle 1: Days -1, 3, 8, 15; Cycles 2, 3: Days 1, 8, 15.

DRUG

placebo

Volume as equivalent to corresponding SGN 40 dose IV. Cycle 1: Days -1, 3, 8, 15. Cycles 2, 3: Days 1, 8, 15.

DRUG

rituximab

375 mg/m2 IV. Cycle 1: Day -2; Cycles 2, 3: Day 1

DRUG

etoposide

100 mg/m2 IV. Cycles 1-3: Days 1, 2 and 3.

DRUG

carboplatin

AUC=5 mg/mL min IV. Cycles 1-3: Day 2.

DRUG

ifosfamide

5 g/m2 24 hr. IV infusion. Cycles 1-3: Day2.

Sponsors & Collaborators

  • Genentech, Inc.

    collaborator INDUSTRY

  • Seagen Inc.

    lead INDUSTRY

Principal Investigators

  • Jonathan Drachman, MD · Seagen Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2009-12-31
Completion
2011-05-31

Countries

  • United States
  • Australia
  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Spain

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 NCT00529503 on ClinicalTrials.gov