CT-011 MAb in DLBCL Patients Following ASCT

Primary Mediastinal Large B-Cell Lymphoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00532259
• Other study ID #: CT-2007-01
• Status: Completed
• Phase: Phase 2
• First received: September 19, 2007
• Last updated: September 8, 2014
• Start date: October 2007
• Est. completion date: August 2011

Study information

• Verified date: September 2014
• Source: CureTech Ltd
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationIsrael: Ministry of HealthIndia: Ministry of HealthChile: Ministry of Health
• Study type: Interventional

Clinical Trial 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 (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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse
• Lymphoma, Large Cell, Diffuse
• Lymphoma, Mixed Cell, Diffuse
• Lymphoma, Non-Hodgkin
• Primary Mediastinal Large B-Cell Lymphoma

Intervention

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.

Locations

Country	Name	City	State
India	Gujarat Cancer and Research Institute	Ahmedabad
India	Rajiv Gandhi Cancer Institute and Research Centre	Delhi
India	Jaslok Hospital and Research Centre	Mumbai	Maharashtra
India	Deenanath Mangeshkar Hospital and Research Centre	Pune	Maharashtra
Israel	Rambam Medical Center	Haifa
Israel	Hadassah Medical Organization	Jerusalem
Israel	Chaim Sheba Medical Center	Tel Hashomaer, Ramat Gan
United States	University of Michigan	Ann Arbor	Michigan
United States	Emory University-Winship Cancer Institute	Atlanta	Georgia
United States	Northside Hospital	Atlanta,	Georgia
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Northwestestern Memorial Hospital	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	The University of Chicago	Chicago	Illinois
United States	Case Western Reserve University	Cleveland	Ohio
United States	Ohio State University	Colombus	Ohio
United States	Baylor Sammons Cancer Center	Dallas,	Texas
United States	Karmanos Cancer Institute	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Cancer Center of the Carolinas	Greenville	South Carolina
United States	M.D. Anderson Cancer Center	Houston	Texas
United States	Moores UCSD Cancer Center	La Jolla,	California
United States	Sarah Cannon Research Institute	Nashville	Tennessee
United States	Temple University	Philadelphia	Pennsylvania
United States	The University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Scripps Cancer Center	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
CureTech Ltd

Countries where clinical trial is conducted

United States,  India,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free Survival	PFS (progression-free survival ) will be determined at the eligible patient populations	16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).	No
Secondary	Overall Survival		within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).	No