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CT-011 MAb in DLBCL Patients Following ASCT

Primary Purpose

Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse, Primary Mediastinal Large B-Cell Lymphoma

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CT-011
Sponsored by
CureTech Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Large Cell, Diffuse focused on measuring Lymphoma, Large B-Cell, Diffuse, Transformed Follicular Lymphoma, Stem cell transplantation, Relapsed, Refractory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Moores UCSD Cancer Center
  • Scripps Cancer Center
  • Northside Hospital
  • Emory University-Winship Cancer Institute
  • Northwestestern Memorial Hospital
  • Rush University Medical Center
  • The University of Chicago
  • Dana-Farber Cancer Institute
  • University of Michigan
  • Karmanos Cancer Institute
  • University of North Carolina
  • Duke University Medical Center
  • Case Western Reserve University
  • Ohio State University
  • Temple University
  • The University of Pittsburgh Medical Center
  • Cancer Center of the Carolinas
  • Sarah Cannon Research Institute
  • Baylor Sammons Cancer Center
  • M.D. Anderson Cancer Center
  • Jaslok Hospital and Research Centre
  • Deenanath Mangeshkar Hospital and Research Centre
  • Gujarat Cancer and Research Institute
  • Rajiv Gandhi Cancer Institute and Research Centre
  • Rambam Medical Center
  • Hadassah Medical Organization
  • Chaim Sheba Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CT-011

Arm Description

The monoclonal antibody termed CT-011 (currently, pidilizumab).

Outcomes

Primary Outcome Measures

Progression-free Survival
PFS (progression-free survival ) will be determined at the eligible patient populations

Secondary Outcome Measures

Overall Survival

Full Information

First Posted
September 19, 2007
Last Updated
September 8, 2014
Sponsor
CureTech Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00532259
Brief Title
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

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CureTech Ltd

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT-011
Arm Type
Experimental
Arm Description
The monoclonal antibody termed CT-011 (currently, pidilizumab).
Intervention Type
Drug
Intervention Name(s)
CT-011
Other Intervention Name(s)
Pidilizumab
Intervention Description
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.
Primary Outcome Measure Information:
Title
Progression-free Survival
Description
PFS (progression-free survival ) will be determined at the eligible patient populations
Time Frame
16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).
Secondary Outcome Measure Information:
Title
Overall Survival
Time Frame
within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leo I Gordon, MD
Organizational Affiliation
Northwestern University Feinberg School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Arnon Nagler, MD
Organizational Affiliation
Chaim Sheba Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moores UCSD Cancer Center
City
La Jolla,
State/Province
California
ZIP/Postal Code
92093-0706
Country
United States
Facility Name
Scripps Cancer Center
City
San Diego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Northside Hospital
City
Atlanta,
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Emory University-Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Northwestestern Memorial Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3008
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0473
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of North Carolina
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Ohio State University
City
Colombus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Temple University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2442
Country
United States
Facility Name
The University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Cancer Center of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Baylor Sammons Cancer Center
City
Dallas,
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
M.D. Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Jaslok Hospital and Research Centre
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400026
Country
India
Facility Name
Deenanath Mangeshkar Hospital and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411004
Country
India
Facility Name
Gujarat Cancer and Research Institute
City
Ahmedabad
ZIP/Postal Code
380016
Country
India
Facility Name
Rajiv Gandhi Cancer Institute and Research Centre
City
Delhi
ZIP/Postal Code
110085
Country
India
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomaer, Ramat Gan
Country
Israel

12. IPD Sharing Statement

Citations:
PubMed Identifier
24127452
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.
Results Reference
derived

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CT-011 MAb in DLBCL Patients Following ASCT

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