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Clinical Trial 3526

NATIONWIDE


Study Summary:

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.