CT-011 MAb in DLBCL Patients Following ASCT

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
CureTech Ltd
ClinicalTrials.gov Identifier:
NCT00532259
First received: September 19, 2007
Last updated: September 8, 2014
Last verified: September 2014
  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
Drug: CT-011
Phase 2

Study Type: Interventional
Study Design: 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:


Further study details as provided by CureTech Ltd:

Primary Outcome Measures:
  • Progression-free Survival [ Time Frame: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT). ] [ Designated as safety issue: No ]
    PFS (progression-free survival ) will be determined at the eligible patient populations


Secondary Outcome Measures:
  • Overall Survival [ Time Frame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: October 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT-011
The monoclonal antibody termed CT-011 (currently, pidilizumab).
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.
Other Name: Pidilizumab

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. Serious other illness.
  2. Active autoimmune disease.
  3. Type 1 diabetes.
  4. Known immune deficiency.
  5. Clinical evidence of primary or secondary brain or spinal cord involvement by lymphoma.
  6. Active bacterial, fungal, or viral infection.
  7. Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus viremia.
  8. Pregnant or nursing (positive pregnancy test).
  9. Other concurrent clinical study or investigational therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 by CureTech Ltd

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: CureTech Ltd
ClinicalTrials.gov Identifier: NCT00532259     History of Changes
Other Study ID Numbers: CT-2007-01
Study First Received: September 19, 2007
Results First Received: September 22, 2013
Last Updated: September 8, 2014
Health Authority: United States: Food and Drug Administration
Israel: Ministry of Health
India: Ministry of Health
Chile: 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, B-Cell
Lymphoma, Large B-Cell, Diffuse
Lymphoma, Non-Hodgkin
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Antibodies, Monoclonal
Immunologic Factors
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014