Phase 2
N=72
CT-011 MAb in DLBCL Patients Following ASCT
Lymphoma, Large Cell, Diffuse · Lymphoma, Mixed Cell, Diffuse · Primary Mediastinal Large B-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT00532259 ↗Enrolled (actual)
72
Serious AEs
31.9%
Results posted
Sep 2014
Primary outcome: Primary: Progression-free Survival — 72 Percent
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- CT-011 (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CureTech Ltd
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival |
72 | — |
| SECONDARY Overall Survival |
85 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT00532259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.