Lymphoma, B-Cell Clinical Trial
Official title:
A Pilot Study of Blinatumomab in Combination With a PD1 Inhibitor, Pembrolizumab, in Pediatric and Young Adult Patients With Relapsed/Refractory CD19 Positive B-cell Acute Leukemia or Lymphoma
This study combines the immune checkpoint inhibitor pembrolizumab with the BITE antibody blinatumomab for the treatment of relapsed/refractory pre-B cell ALL. Pembrolizumab at the proposed dosing schedule has been very well tolerated in adult studies, including elderly and unfit patients, as well as in pediatric patients. Both blinatumomab and pembrolizumab are FDA-approved for use in children as well as adults. Phase I/II trials in adult patients have demonstrated safety and activity of pembrolizumab in combination with multiple agents. In this trial, the combination of pembrolizumab and blinatumomab will be investigated for toxicity as well as possible synergy in the treatment of relapsed/refractory pre-B cell ALL. This is a single institution investigator-initiated pilot study designed to test the safety and feasibility of combining pembrolizumab and blinatumomab immunotherapies in children, adolescents, and young adults with CD19 positive hematologic malignancies. The investigator will define the toxicity profile of the combination in two safety strata based on whether or not a patient has had a prior allogeneic hematopoietic stem cell transplant (HSCT), as they hypothesize that the immune toxicities may differ between strata. In addition, the overall response rate (CR/CRh) to this therapy will be estimated. Additional biologic correlates will be conducted to delineate the effect of the combination therapy on the patient's leukemia/lymphoma and T-cell populations and how this may influence response to therapy.
Participants who meet study eligibility will receive or continue to receive blinatumomab by continuous IV infusion for 28 days and also receive pembrolizumab (by IV infusion over 30 minutes) on day 12 of cycle 1 and day 5 of cycle 2. One cycle lasts 35 days and patients will receive 2 cycles of therapy. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05540340 -
A Study of Melphalan in People With Lymphoma Getting an Autologous Hematopoietic Cell Transplant
|
N/A | |
| Completed |
NCT03415399 -
Clinical Study of ET190L1 ARTEMIS™ in Relapsed, Refractory B Cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT04807881 -
Phase Ib Clinical Study of Keynatinib
|
Phase 1 | |
| Recruiting |
NCT05510596 -
Magnetic Resonance Imaging in Immune Effector Cell-Associated Neurotoxicity Syndrome
|
N/A | |
| Not yet recruiting |
NCT06350994 -
Early Assessment of Cardiac Function After Treatment With CAR-T Cells
|
||
| Terminated |
NCT02670317 -
Phase II Study About Combination CHOP-21, Obinutuzumab and Ibrutinib in Untreated Young High Risk DLBCL Patients.
|
Phase 2 | |
| Completed |
NCT00998946 -
Study of Pralatrexate to Treat Participants With Relapsed or Refractory B-cell Non-Hodgkin's Lymphoma
|
Phase 2 | |
| Terminated |
NCT00768339 -
A Phase 1-2, Multicenter, Open-Label Study of AEG35156 in Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia and Indolent B-Cell Lymphomas
|
Phase 1/Phase 2 | |
| Withdrawn |
NCT00538096 -
A Phase I Study to Evaluate Safety, Tolerability in Adults With Lymphoma
|
Phase 1 | |
| Terminated |
NCT00521638 -
Study Evaluating TRU-015 in B-Cell Non-Hodgkin's Lymphoma
|
Phase 1 | |
| Completed |
NCT00379574 -
Bortezomib Plus CHOP Every 2 Weeks for Advanced Stage DLBCL
|
Phase 1/Phase 2 | |
| Completed |
NCT00156013 -
Clofarabine for Relapsed or Refractory T-Cell or B-Cell Non-Hodgkin Lymphoma (NHL)
|
Phase 1/Phase 2 | |
| Completed |
NCT00147121 -
Rituximab+Standard CHOP vs Rituximab+Bi-weekly CHOP for Untreated Stage III/IV Low-grade B-cell Lymphoma (JCOG0203)
|
Phase 2/Phase 3 | |
| Recruiting |
NCT04594798 -
A Study of Polatuzumab Vedotin, Rituximab and Dose Attenuated CHP in Older Patients With DLBCL
|
Phase 2 | |
| Recruiting |
NCT04161248 -
Phase I Master Protocol of Novel Combination Therapy for Patients With Relapsed or Refractory Aggressive B-Cell Lymphoma
|
Early Phase 1 | |
| Withdrawn |
NCT04052061 -
QUILT-3.061: CD19 t-haNK in Subjects With Diffuse Large B-Cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT04884035 -
Study of Safety and Efficacy of Iberdomide (CC-220) and CC-99282 Combined With R-CHOP to Treat Lymphoma
|
Phase 1 | |
| Not yet recruiting |
NCT05834426 -
Omic Technologies Applied to the Study of B-cell Lymphoma for the Discovery of Diagnostic and Prognosis Biomarkers
|
||
| Recruiting |
NCT05376709 -
A Mixed Methods Study of Nutrition Practice in Cancer Care on Non-Hodgkin Lymphoma Population
|
N/A | |
| Recruiting |
NCT04649983 -
CD19 and CD22 Targeted CAR-T Cell Therapy for Relapsed/Refractory B Cell Leukemia and Lymphoma
|
Phase 1/Phase 2 |