Waldenstrom Macroglobulinemia Clinical Trial
Official title:
An Open-Label, Multicenter Phase 2 Study to Evaluate the Efficacy and Safety of BCL2 Inhibitor BGB-11417 in Patients With Relapsed/Refractory Waldenström's Macroglobulinemia
This study will evaluate the safety and efficacy of the BCL2 inhibitor BGB-11417 in participants with relapsed/refractory Waldenström's Macroglobulinemia (R/R WM) in 3 cohorts.
This study will test whether BGB-11417 can be used to improve outcomes in participants with Waldenström's Macroglobulinemia (WM) who have not responded well to conventional treatments. The main goals of the study are to determine how many participants may no longer have evidence of cancer or have some improvement in the signs and symptoms of cancer after treatment, and to determine what adverse events, or side effects, participants might experience. BCL2 is a key protein involved in cell death, and abnormal levels of BCL2 are associated with many cancers. Blocking the action of BCL2 proteins is a promising approach with potential therapeutic benefits in participants with different types of cancers, including WM. This study will enroll approximately 85 patients. All patients will receive BGB-11417 orally as a tablet. The study will take place at multiple centers worldwide. The overall time to participate in this study is approximately 5 years. Treatments will continue until participants experience worsening disease status, too many side effects, or withdraw consent. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Enrolling by invitation |
NCT01804686 -
A Long-term Extension Study of PCI-32765 (Ibrutinib)
|
Phase 3 | |
| Completed |
NCT03630042 -
Investigating the Safety and Efficacy of Rituximab and Pembrolizumab in Relapsed/Refractory Waldenström's Macroglobulinaemia
|
Phase 2 | |
| Completed |
NCT02916979 -
Myeloid-Derived Suppressor Cells and Checkpoint Immune Regulators' Expression in Allogeneic SCT Using FluBuATG
|
Phase 1 | |
| Active, not recruiting |
NCT05024045 -
Study of Oral LOXO-338 in Patients With Advanced Blood Cancers
|
Phase 1 | |
| Completed |
NCT04062448 -
A Study of Ibrutinib in Combination With Rituximab, in Japanese Participants With Waldenstrom's Macroglobulinemia (WM)
|
Phase 2 | |
| Completed |
NCT01527045 -
Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies
|
Phase 2 | |
| Recruiting |
NCT03679455 -
A Study of Obinutuzumab (RO5072759) Induction in Patients With Relapsed/ Refractory Waldenström Macroglobulinemia, OBI-1
|
Phase 2 | |
| Not yet recruiting |
NCT04830046 -
Covid-19 Vaccine Responsiveness in MM and Waldenstrom
|
||
| Terminated |
NCT02109224 -
Ibrutinib in Treating Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma in Patients With HIV Infection
|
Phase 1 | |
| Completed |
NCT01093586 -
Donor Umbilical Cord Blood Stem Cell Transplant in Treating Patients With Hematologic Malignancies
|
Phase 2 | |
| Active, not recruiting |
NCT03620903 -
Efficacy of First Line B-RI for Treatment Naive Waldenström's Macroglobulinemia
|
Phase 2 | |
| Not yet recruiting |
NCT04702932 -
Establishment of Genomic, Transcriptomic and Functional Characteristics of Tumor Cells in Hyperinflammatory Hemopathies
|
||
| Active, not recruiting |
NCT03133221 -
1630GCC: Zydelig Maintenance in B-Cell Non-Hodgkin's Lymphoma After Autologous Stem Cell Transplantation
|
Phase 2 | |
| Not yet recruiting |
NCT05099471 -
Efficacy of Venetoclax in Combination With Rituximab in Waldenström's Macroglobulinemia
|
Phase 2 | |
| Completed |
NCT00608361 -
Dasatinib in Treating Patients With Solid Tumors or Lymphomas That Are Metastatic or Cannot Be Removed By Surgery
|
Phase 1 | |
| Completed |
NCT00777738 -
Efficacy of Bortezomib (Velcade(R)) in Patients With Advanced Waldenström Macroglobulinemia
|
Phase 2 | |
| Completed |
NCT00438880 -
Agatolimod Sodium, Rituximab, and Yttrium Y 90 Ibritumomab Tiuxetan in Treating Patients With Recurrent or Refractory Non-Hodgkin Lymphoma
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT00075478 -
Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer
|
Phase 3 | |
| Completed |
NCT01272817 -
Nonmyeloablative Allogeneic Transplant
|
N/A | |
| Recruiting |
NCT04116437 -
Zanubrutinib (BGB-3111) in Participants With Previously Treated B-Cell Lymphoma Intolerant of Prior Bruton Tyrosine Kinase Inhibitor (BTKi) Treatment
|
Phase 2 |