CT-011 MAb in DLBCL Patients Following ASCT

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: CT-011


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-011<br>The monoclonal antibody termed CT-011 (currently, pidilizumab). | Drug: CT-011<br>* 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.<br>* Other names: Pidilizumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | PFS (progression-free survival ) will be determined at the eligible patient populations | 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival |  | within 16 months following the first CT-011 treatment (18 months following autologous PBSCT). | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphoma, Large B-Cell, Diffuse, Transformed Follicular Lymphoma, Stem cell transplantation, Relapsed, Refractory