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Intensive Consolidation and Stem Cell Mobilization Therapy Followed by Autologous Stem Cell Transplantation in High-risk Patients With Relapsed/Refractory Diffuse Large B-Cell Lymphoma

NCT01555541 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2022-06-29

Study results available
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Summary

The goal of this clinical trial is to show that incorporating ofatumumab instead of rituximab in combination with etoposide and cytarabine (OVA) is successful in collecting autologous stem cells for use in an autologous stem cell transplantation (autoSCT) and to examine its effectiveness in eliminating residual diffuse large B-Cell Lymphoma (DLBCL) in patients.

Conditions

  • Diffuse Large Cell Lymphoma Relapsed/Refractory

Interventions

DRUG

Ofatumumab

1000 mg IV days 0, 7, 14, 21

DRUG

Etoposide

10 mg/Kg IV over 24 hours daily, days 1-4

DRUG

Cytarabine

2000 mg/m2 IV twice daily, days 1-4

Sponsors & Collaborators

Principal Investigators

  • Charalambos Andreadis, MD, MSCE · University of California, San Francisco

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-05-25
Primary Completion
2017-07-06
Completion
2021-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT01555541 on ClinicalTrials.gov