CT-011 MAb in DLBCL Patients Following ASCT
CT-011 MAb in DLBCL Patients Following ASCT
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.
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.