Clinical trial NCT00532259: CT-011 MAb in DLBCL Patients Following ASCT
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Lymphoma, Large Cell, Diffuse
Lymphoma, Mixed Cell, Diffuse
Primary Mediastinal Large B-Cell Lymphoma
Keywords: Lymphoma, Large B-Cell, Diffuse
Transformed Follicular Lymphoma
Stem cell transplantation
Relapsed
Refractory
Lead sponsor: CureTech Ltd
Sponsor class: INDUSTRY
First posted: 2007-09-20
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 (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.


Eligibility 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.

Primary outcomes:
measure: Progression-free Survival
timeFrame: 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).
Secondary outcomes:
measure: Overall Survival
timeFrame: within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).
Other outcomes:
Locations:
city: La Jolla,
country: United States
facility: Moores UCSD Cancer Center
state: California
city: San Diego
country: United States
facility: Scripps Cancer Center
state: California
city: Atlanta,
country: United States
facility: Northside Hospital
state: Georgia
city: Atlanta
country: United States
facility: Emory University-Winship Cancer Institute
state: Georgia
city: Chicago
country: United States
facility: Northwestestern Memorial Hospital
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Chicago
country: United States
facility: The University of Chicago
state: Illinois
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cleveland
country: United States
facility: Case Western Reserve University
state: Ohio
city: Colombus
country: United States
facility: Ohio State University
state: Ohio
city: Philadelphia
country: United States
facility: Temple University
state: Pennsylvania
city: Pittsburgh
country: United States
facility: The University of Pittsburgh Medical Center
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Center of the Carolinas
state: South Carolina
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Dallas,
country: United States
facility: Baylor Sammons Cancer Center
state: Texas
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
city: Mumbai
country: India
facility: Jaslok Hospital and Research Centre
state: Maharashtra
city: Pune
country: India
facility: Deenanath Mangeshkar Hospital and Research Centre
state: Maharashtra
city: Ahmedabad
country: India
facility: Gujarat Cancer and Research Institute
city: Delhi
country: India
facility: Rajiv Gandhi Cancer Institute and Research Centre
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
city: Tel Hashomaer, Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center
Study officials:
affiliation: Northwestern University Feinberg School of Medicine
name: Leo I Gordon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chaim Sheba Medical Center
name: Arnon Nagler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Armand P, Nagler A, Weller EA, Devine SM, Avigan DE, Chen YB, Kaminski MS, Holland HK, Winter JN, Mason JR, Fay JW, Rizzieri DA, Hosing CM, Ball ED, Uberti JP, Lazarus HM, Mapara MY, Gregory SA, Timmerman JM, Andorsky D, Or R, Waller EK, Rotem-Yehudar R, Gordon LI. Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial. J Clin Oncol. 2013 Nov 20;31(33):4199-206. doi: 10.1200/JCO.2012.48.3685. Epub 2013 Oct 14.