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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
Not Enrolling
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

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

6. Active bacterial, fungal, or viral infection.

7. Positive HIV, Hepatitis B surface antigen plus viremia, or Hepatitis C antibody plus

8. Pregnant or nursing (positive pregnancy test).

9. Other concurrent clinical study or investigational therapy.

Type of Study:


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:


Principal Investigator

Leo I Gordon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University Feinberg School of Medicine


United States: Food and Drug Administration

Study ID:




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



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