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