Follicular Lymphoma Clinical Trial
Official title:
Frontline Treatment of Follicular Lymphoma With AtezolizUmab and Obinutuzumab With and Without RadiOtherapy
This single-arm phase II interventional study aims to assess disease response to, and toxicity of, a combination of obinutuzumab and atezolizumab, with or without radiotherapy, in treatment naive Follicular Lymphoma. The study will involve an induction phase and a maintenance phase for responding participants, for up to 24 months. Response to treatment will be monitored using medical imaging and clinical assessment.
This is a single-arm phase II study of obinutuzumab, atezolizumab with or without RT in treatment-naïve advanced FL. Participants will initially receive 2 cycles of induction treatment with obinutuzumab and atezolizumab. During cycle 2, participants will undergo disease assessment by PET/CT scan, results of which will determine further induction treatment. Participants in Complete Medical Response (CMR) according to Lugano criteria will receive an additional 4 cycles of induction treatment. Participants who achieve a partial response (PR), stable disease (SD) or deemed to have minor/asymptomatic progressive disease (PD) will also receive 4 further cycles of induction treatment, with the addition of involved-site RT to residual sites of disease (4Gy in 2 fractions), administered between cycle 3 and cycle 4. Participants with symptomatic PD following 2 cycles of induction treatment will not receive any further study treatment. Further treatment will be at the discretion of the treating clinician. At the end of the induction phase, disease response will again be assessed by PET/CT scan. All participants in CR, PR or SD will move into the maintenance phase of the study and will receive obinutuzumab for 24 months (up to a total of 12 doses). Participants with PD at the end of induction will cease protocol treatment and further treatment will be as per local guidelines. ;
| 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 |
NCT03245021 -
Nivolumab Plus Rituximab in First-line Follicular Lymphoma gr 1-3A
|
Phase 1 | |
| Active, not recruiting |
NCT03078855 -
A Study to Evaluate the Effect of Vitamin D on PFS in Indolent Non-Hodgkin's Lymphoma
|
Phase 3 | |
| 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 | |
| Completed |
NCT02536664 -
Non-Interventional Study to Examine Rituximab Treatment in Follicular Lymphoma Participants
|
||
| 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 | |
| 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)
|