Follicular Lymphoma Clinical Trial
Official title:
A Phase 2, Single Arm Study Evaluating the Safety and Efficacy of Idelalisib in Combination With Rituximab for Previously Untreated Follicular Lymphoma and Small Lymphocytic Lymphoma
The primary objective of this study is to evaluate the overall response rate (ORR) and
complete response (CR) rate to treatment with idelalisib in combination with rituximab in
previously untreated adults with follicular lymphoma (FL) or small lymphocytic lymphoma
(SLL).
An increased rate of deaths and serious adverse events (SAEs) among participants with
front-line chronic lymphocytic leukemia (CLL) and early-line indolent non-Hodgkin lymphoma
(iNHL) treated with idelalisib in combination with standard therapies was observed by the
independent data monitoring committee (DMC) during regular review of 3 Gilead Phase 3
studies. Gilead reviewed the unblinded data and terminated those studies in agreement with
the DMC recommendation and in consultation with the US Food and Drug Administration (FDA).
All front-line studies of idelalisib, including this study, were also terminated.
n/a
| 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 | |
| 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)
|