Clinical trial · Interventional
CT-011 MAb in DLBCL Patients Following ASCT
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Large Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Lymphoma, Mixed Cell, Diffuse | Lymphoma | ONTOLOGY_EXACT | 0.85 |
| Primary Mediastinal Large B-Cell Lymphoma | Primary Mediastinal Large B-Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CT-011 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CT-011
- description
- The monoclonal antibody termed CT-011 (currently, pidilizumab).
- interventionNames
- Drug: CT-011
Primary outcomes (1)
- measure
- Progression-free Survival
- timeFrame
- 16 months following the first CT-011 administration (approximately 18 months following autologous PBSCT).
- description
- PFS (progression-free survival ) will be determined at the eligible patient populations
Secondary outcomes (1)
- measure
- Overall Survival
- timeFrame
- within 16 months following the first CT-011 treatment (18 months following autologous PBSCT).
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDArmand P, Nagler A, Weller EA, Devine SM, Avigan DE, Chen YB, Kaminski MS, Holland HK, Winter JN, Mason JR, Fay JW, Rizzieri DA, Hosing CM, Ball ED, Uberti JP, Lazarus HM, Mapara MY, Gregory SA, Timmerman JM, Andorsky D, Or R, Waller EK, Rotem-Yehudar R, Gordon LI. Disabling immune tolerance by programmed death-1 blockade with pidilizumab after autologous hematopoietic stem-cell transplantation for diffuse large B-cell lymphoma: results of an international phase II trial. J Clin Oncol. 2013 Nov 20;31(33):4199-206. doi: 10.1200/JCO.2012.48.3685. Epub 2013 Oct 14. PMID 24127452