Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials!!

Clinical Trial 3528

Durham, NC 27710


Study Summary:

BCell3526 cancer

Trial Information

Summary: A Study of the Monoclonal Antibody CT-011 in Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation.

Status: Recruiting

Protocol Number: CT-2007-01

Sponsor: CureTech Ltd.

Company Division: Pharmaceutical

Official Scientific Title: Phase II Safety and Efficacy Study of the Monoclonal Antibody CT-011 in Patients with Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation.

Brief 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 (60 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 16 months after the first administration of CT-011. Approximately 70 patients will participate in this study.

Study Phase: II

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Intervention Model: Single Group Assignment
  • Masking: Open Label
  • Control: Uncontrolled
  • Endpoints: Safety/Efficacy

Study Type: Interventional

Conditions: Lymphoma, Large Cell, Diffuse
Lymphoma, Mixed Cell, Diffuse
Primary Mediastinal Large B-Cell Lymphoma
Transformed Follicular Lymphoma

Intervention Type: Drug (antibody)

Intervention Name: CT-011

Primary Outcome: 1. Progression-free survival; Time frame: 16 months following the first CT-011 treatment.

Key Secondary Outcomes: 1) Toxicity and safety 2) Event free survival. 3) Overall survival; Time frame: 16 months following the first CT-011 treatment.

Inclusion Criteria:

  • Adult patients, >=18 years of age;
  • Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma
  • The lymphoma is chemosensitive
  • The lymphoma did not progress since pre transplant chemotherapy.
  • ECOG performance status 0-1.

Exclusion Criteria:

  • Other serious illness.
  • Active autoimmune disease.
  • Type 1 diabetes.
  • Known immune deficiency.
  • Clinical evidence of primary or secondary brain or spinal cord (CNS) involvement by lymphoma.
  • Active bacterial, fungal, or viral infection.
  • Positive HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
  • Pregnant or nursing (positive pregnancy test).
  • Other concurrent clinical study or investigational therapy.

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No


Clinical trials are medical research studies designed to test the safety and/or effectiveness of new investigational drugs, devices, or treatments in humans. These studies are conducted worldwide for a range of conditions and illnesses. Learn more about clinical research and participating in a study at About Clinical Trials.