A Study of the Monoclonal Antibody CT-011 in Diffuse Large B-Cell Lymphoma Following Autologous Stem Cell Transplantation - Full Text View

Sponsor:	CureTech Ltd
Information provided by (Responsible Party):	CureTech Ltd
ClinicalTrials.gov Identifier:	NCT00532259

Purpose

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.

Condition	Intervention	Phase
Lymphoma, Large Cell, Diffuse Lymphoma, Mixed Cell, Diffuse Primary Mediastinal Large B-Cell Lymphoma Transformed Follicular Lymphoma Relapsed	Drug: CT-011	Phase II

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lymphoma

Drug Information available for: Immunoglobulins Globulin, Immune

U.S. FDA Resources

Further study details as provided by CureTech Ltd:

Primary Outcome Measures:

To determine the progression-free survival of the patients, defined as the proportion of patients who have not relapsed or died [ Time Frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

• Toxicity and safety. • Event free survival (events are defined as relapse, second malignancy or death). • Overall survival. [ Time Frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	70
Study Start Date:	October 2007
Study Completion Date:	August 2011
Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Intervention Details:

IV infusion of 1.5 mg/kg 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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patient's age is 18 years or older, both genders.
Confirmed Diffuse Large B-cell Lymphoma, transformed follicular lymphoma, diffuse mixed cell lymphoma or primary mediastinal large cell lymphoma with B-cell lineage.
The lymphoma is chemosensitive.
The lymphoma did not progress since pre-transplant chemotherapy.
ECOG performance status 0-1.

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532259

Show 27 Study Locations

Sponsors and Collaborators

CureTech Ltd

Investigators

Principal Investigator:	Leo I Gordon, MD	Northwestern University Feinberg School of Medicine
Principal Investigator:	Arnon Nagler, MD	Chaim Sheba Medical Center

More Information

No publications provided

Responsible Party:	CureTech Ltd
ClinicalTrials.gov Identifier:	NCT00532259 History of Changes
Other Study ID Numbers:	CT-2007-01
Study First Received:	September 19, 2007
Last Updated:	September 27, 2011
Health Authority:	United States: Food and Drug Administration; Israel: Ministry of Health

Keywords provided by CureTech Ltd:

Lymphoma, Large B-Cell, Diffuse
Transformed Follicular Lymphoma
Stem cell transplantation
Relapsed
Refractory

Additional relevant MeSH terms:

Lymphoma
Lymphoma, Follicular
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders

Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 02, 2012