Experts discuss balancing efficacy and safety in BTK inhibitor plus venetoclax combination therapy for CLL, including BTK lead-in strategies to reduce tumor lysis syndrome risk and the benefits of all-oral fixed-duration regimens.
The FDA approved acalabrutinib plus venetoclax for previously untreated CLL/SLL based on phase 3 AMPLIFY data. The fixed 14-month regimen improved progression-free survival versus chemotherapy.
The FDA approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration regimen for adults with previously untreated chronic lymphocytic leukemia or small lymphocytic lymphoma, based on Phase 3 AMPLIFY trial results.
The FDA has approved the combination of acalabrutinib and venetoclax as the first all-oral, fixed-duration BTK inhibitor-based regimen for previously untreated adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma.
The FDA has approved a supplemental new drug application for the combination regimen of Venclexta (venetoclax) and acalabrutinib for previously untreated adult patients with chronic lymphocytic leukemia, supported by Phase 3 AMPLIFY trial data.
The FDA approved acalabrutinib plus venetoclax as the first all-oral, fixed-duration regimen for previously untreated chronic lymphocytic leukemia, based on phase III AMPLIFY trial results showing 35% reduction in disease progression or death risk versus chemoimmunotherapy.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT04745910 |
Pegloticase for the Reduction of Uric Acid in Patients With Tumor Lysis Syndrome |
COMPLETED | PHASE4 |
| NCT03605212 |
Febuxostat for Tumor Lysis Syndrome Prevention in Hematological Malignancies of Paediatric Patients and Adults |
TERMINATED | PHASE1/PHASE2 |
| NCT01724528 |
Febuxostat for Tumor Lysis Syndrome Prevention in Hematologic Malignancies |
COMPLETED | PHASE3 |
| NCT01097369 |
Elitek (Rasburicase) Immuno-Monitoring Study |
TERMINATED | |
| NCT00651911 |
Fasturtec TLS Treatment / Prophylysis |
COMPLETED | PHASE4 |
| NCT00628628 |
Rasburicase in Patients at Risk for Tumor Lysis Syndrome |
COMPLETED | PHASE2 |
| NCT00360438 |
Pharmacokinetic Evaluation of Rasburicase in Patients With Leukemia and/or Lymphoma at High Risk of TLS |
COMPLETED | PHASE1/PHASE2 |
| NCT00230217 |
Study of Rasburicase as Treatment or Prevention of Hyperuricemia Associated With Tumor Lysis Syndrome in Patients With Relapsed or Refractory Lymphoma, Leukemia, or Solid Tumor Malignancy |
COMPLETED | PHASE4 |
| NCT00230178 |
Rasburicase Versus Allopurinol in Tumor Patients at Risk for Hyperuricemia and Tumor Lysis Syndrome |
COMPLETED | PHASE3 |
| NCT00186940 |
Rasburicase Treatment for Chemotherapy or Malignancy-Induced Hyperuricemia in Asthma/Allergy Patients |
COMPLETED |
