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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


Phase 2
18 Years
N/A
Not Enrolling
Both
Lymphoma, Large Cell, Diffuse, Lymphoma, Mixed Cell, Diffuse, Primary Mediastinal Large B-Cell Lymphoma, Transformed Follicular Lymphoma, Relapsed

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

To determine the progression-free survival of the patients, defined as the proportion of patients who have not relapsed or died

Outcome Time Frame:

within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).

Safety Issue:

No

Principal Investigator

Leo I Gordon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University Feinberg School of Medicine

Authority:

United States: Food and Drug Administration

Study ID:

CT-2007-01

NCT ID:

NCT00532259

Start Date:

October 2007

Completion Date:

August 2011

Related Keywords:

  • Lymphoma, Large Cell, Diffuse
  • Lymphoma, Mixed Cell, Diffuse
  • Primary Mediastinal Large B-Cell Lymphoma
  • Transformed Follicular Lymphoma
  • Relapsed
  • Lymphoma, Large B-Cell, Diffuse
  • Transformed Follicular Lymphoma
  • Stem cell transplantation
  • Relapsed
  • Refractory
  • Lymphoma
  • Lymphoma, Follicular
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse

Name

Location
University of Michigan Ann Arbor, Michigan  48109-0624
Rush University Medical Center Chicago, Illinois  60612-3824
Dana-Farber Cancer Institute Boston, Massachusetts  02115
Moores UCSD Cancer Center La Jolla, California  92093-0658
Temple University Philadelphia, Pennsylvania  19140
University of North Carolina Chapel Hill, North Carolina  27599
Duke University Medical Center Durham, North Carolina  27710
Scripps Cancer Center La Jolla, California  92037
Case Western Reserve University Cleveland, Ohio  44106
Ohio State University Columbus, Ohio  43210
M.D. Anderson Cancer Center Houston, Texas  77030
The University of Chicago Chicago, Illinois  60637
Karmanos Cancer Institute Detroit, Michigan  48201
Cancer Center of the Carolinas Greenville, South Carolina  29615
Northside Hospital Atlanta, Georgia  30342
Sarah Cannon Research Institute Nashville, Tennessee  37203
Baylor Sammons Cancer Center Dallas, Texas  75246
Emory University-Winship Cancer Institute Atlanta, Georgia  30322
Northwestestern Memorial Hospital Chicago, Illinois  60611-3008
The University of Pittsburgh Medical Center Pittsburgh, Pennsylvania  15232