Follicular Lymphoma Clinical Trial
Official title:
Phase I Dose Escalation Study of Radiotherapy and Durvalumab in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) and Follicular Lymphoma (FL): The RaDD Study
The primary objective for this study is to determine the safety profile of radiotherapy and durvalumab, a PD-L1 inhibitor. Primary endpoint: Toxicity, drug pharmacokinetics (PK), maximum tolerated dose (MTD) and recommended phase two dose (RPTD) of simultaneous radiotherapy plus durvalumab in patients with relapsed or refractory DLBCL or FL. Secondary endpoints: - ORR - Progression-free survival - Overall survival Exploratory endpoints include description of biological effects of combination radiotherapy plus durvalumab (Imaging results, immune function, PK and PD-see 'research methodologies') and in the PET-Sub-Study, biodistribution of 89Zr Durvalumab and 89Zr-IAB22M2C.
Diffuse large B cell lymphoma (DLBCL) and Follicular Lymphoma (FL) are the most common non Hodgkin lymphomas. Standard first line treatment achieves cure in approximately half of patients. However 30% die from relapsed lymphoma. Durvalumab (an antibody which blocks programmed cell death ligand 1) and other immunotherapies fight cancer by blocking barriers to immune system activity. Immune control of lymphoma provides the prospect of cure, even when chemotherapy has failed. Radiotherapy has striking effects on the immune system and can boost responses to these immunotherapies. The effect of concurrent radiotherapy and durvalumab in DLBCL and FL is unproven. This study will evaluate the safety and effect of simultaneous radiotherapy plus durvalumab (a PD-L1 inhibitor) in relapsed DLBCL and FL patients. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
| Completed |
NCT00001512 -
Active Specific Immunotherapy for Follicular Lymphomas With Tumor-Derived Immunoglobulin Idiotype Antigen Vaccines
|
Phase 1 | |
| Recruiting |
NCT03676504 -
Treatment of Patients With Relapsed or Refractory CD19+ Lymphoid Disease With T Cells Expressing a Third-generation CAR
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT03078855 -
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
|
Phase 3 | |
| Active, not recruiting |
NCT03245021 -
Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A
|
Phase 1 | |
| Recruiting |
NCT05365659 -
IKS03 in Patients With Advanced B Cell Non-Hodgkin Lymphomas
|
Phase 1 | |
| Active, not recruiting |
NCT04082936 -
A Study of Imvotamab Monotherapy and in Combination in Subjects With Relapsed/Refractory Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Completed |
NCT02213263 -
A Study Of PF-05280586 (Rituximab-Pfizer) Or MabThera® (Rituximab-EU) For The First-Line Treatment Of Patients With CD20-Positive, Low Tumor Burden, Follicular Lymphoma (REFLECTIONS B328-06)
|
Phase 3 | |
| Completed |
NCT01691898 -
A Study of Pinatuzumab Vedotin (DCDT2980S) Combined With Rituximab or Polatuzumab Vedotin (DCDS4501A) Combined With Rituximab or Obinutuzumab in Participants With Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (NHL)
|
Phase 1/Phase 2 | |
| Terminated |
NCT03585725 -
A Pilot Investigator-Initiated Study of Ribavirin in Indolent Follicular Lymphoma and Mantle Cell Lymphoma
|
Early Phase 1 | |
| Terminated |
NCT00772668 -
Rituximab, Cyclophosphamide, Bortezomib, and Prednisone in Patients With Stage III/IV FL or MZL
|
N/A | |
| Recruiting |
NCT02892695 -
PCAR-119 Bridge Immunotherapy Prior to Stem Cell Transplant in Treating Patients With CD19 Positive Leukemia and Lymphoma
|
Phase 1/Phase 2 | |
| Terminated |
NCT02877082 -
Tacrolimus, Bortezomib, & Thymoglobulin in Preventing Low Toxicity GVHD in Donor Blood Stem Cell Transplant Patients
|
Phase 2 | |
| Terminated |
NCT02204982 -
Study of Duvelisib in Combination With Rituximab vs Rituximab in Subjects With Previously Treated Follicular Lymphoma
|
Phase 3 | |
| Terminated |
NCT00850499 -
Phase 2 Study of VELCADE With Fludarabine in Comparison to Rituximab With Fludarabine in Follicular Lymphoma Patients Previously Treated With Rituximab
|
Phase 2 | |
| Completed |
NCT02536664 -
Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
|
||
| Terminated |
NCT00475332 -
Study to Treat Relapsed Follicular Non-Hodgkin's Lymphoma With Radiation and Bexxar
|
Phase 2 | |
| Terminated |
NCT00136591 -
A Phase 2 Study of Velcade™ in Subjects With Relapsed or Refractory Follicular B-Cell Lymphoma
|
Phase 2 | |
| Not yet recruiting |
NCT06068881 -
A Study to Assess Efficacy and Safety of Oral Tazemetostat in Adult Participants With Relapsed/Refractory Follicular Lymphoma That Does Not Have an "EZH2 Gain-of-function" Genetic Mutation
|
Phase 2 | |
| Completed |
NCT04034056 -
Untreated FolliculaR Lymphoma Treated With OBinituzumAb in a Non-interventional Study (URBAN)
|