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CT-011 MAb in DLBCL Patients Following ASCT

NCT00532259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2014-09-12

Study results available
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Summary

Autologous peripheral blood stem cell transplantation combined with high dose chemotherapy is the treatment of choice given to patients with diffuse large-B cell lymphoma (DLBCL) following relapse of the disease. Although many people are cured of their lymphoma with this therapy, the disease comes back in a certain proportion of patients. The purpose of this study is to test the safety and effectiveness of the monoclonal antibody, CT-011, in patients with DLBCL who have received autologous peripheral blood stem cell transplantation. All final eligible patients will receive an IV infusion of CT-011 on Day 1 (30 to 90 days post autologous PBSCT). Treatment will be repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85. Follow-up for safety and clinical outcome will be conducted throughout the study till 18 months post autologous PBSCT. Approximately 70 patients will participate in this study.

Conditions

  • Lymphoma, Large Cell, Diffuse
  • Lymphoma, Mixed Cell, Diffuse
  • Primary Mediastinal Large B-Cell Lymphoma

Interventions

DRUG

CT-011

IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.

Sponsors & Collaborators

  • CureTech Ltd

    lead INDUSTRY

Principal Investigators

  • Leo I Gordon, MD · Northwestern University Feinberg School of Medicine

  • Arnon Nagler, MD · Chaim Sheba Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-10-31
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States
  • India
  • Israel

Study Locations

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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 NCT00532259 on ClinicalTrials.gov