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Study of Ofatumomab in Combination With ICE-chemotherapy in Patients With Diffuse Large B-cell Lymphoma (DLBCL)

NCT02412267 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 17

Last updated 2016-03-23

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of ofatumomab in combination with ICE chemotherapy in subjects with relapsed/refractory DLBCL following failure to combination rituximab and anthracycline based chemotherapy. Participants with the option of potentially curative stem cell therapy may proceed to high dose chemotherapy and stem cell rescue. Participants with disease not considered curable with stem cell therapy, ineligible for or decline stem cell therapy may receive up to a maximum of 6 cycles of study drugs.

Conditions

  • Diffuse Large B-cell Lymphoma

Interventions

DRUG

O-ICE (ofatumumab, Ifosfamide, Carboplatin, Etoposide)

Ofatumab in combination with ICE (Ifosfamide, Carboplatin, Etoposide) are given to subjects according to protocol schedule

Sponsors & Collaborators

  • GlaxoSmithKline

    collaborator INDUSTRY

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Soon Thye Lim, Dr · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2015-12-31
Completion
2016-03-31

Countries

  • Singapore

Study Locations

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Entities

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 NCT02412267 on ClinicalTrials.gov