Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibrutinib · 1 trial · 1 indication
Primary endpoint is the rate of CR or VGPR 12 months after the start of treatment using the response criteria updated at the Sixth IWWM (CR/VGPR).
| Arm | Type | Description |
|---|---|---|
| Arm A: Carfilzomib + Ibrutinib | EXPERIMENTAL | Patients will be treated with Ibrutinib until evidence of progressive disease or no longer tolerated. Patients will receive in addition Carfilzomib for two years. |
| Arm B: Ibrutinib | ACTIVE_COMPARATOR | Patients will be treated with Ibrutinib until evidence of progressive disease or no longer tolerated. |
| Name | Type | Description |
|---|---|---|
| Carfilzomib + Ibrutinib | DRUG | Carfilzomib: Cycle 1, day 1: 20 mg/m² i.v. Cycle 1, day 8, day 15: 70 mg/m² i.v. Cycle 2 - 12, day 1, day 8, day 15: 70 mg/m² i.v. Cycle 13 - 24, day 1, day 15: 70 mg/m² i.v. Ibrutinib: 420 mg p.o daily until disease progression or non-tolerable toxicities |
| Ibrutinib | DRUG | Ibrutinib: 420 mg p.o daily until disease progression or non-tolerable toxicities |
Inclusion Criteria: Each patient must meet all of the following inclusion criteria to be enrolled in this study: * Proven clinicopathological diagnosis of WM as defined by consensus panel one of the Second International Workshop on WM. Histopathology has to occur before randomization within the la...
Ibrutinib is a small molecule being studied for the treatment of Waldenstrom Macroglobulinemia, a rare type of B-cell lymphoma. It is currently in Phase 2 clinical development as an investigational therapy for this condition.
Ibrutinib targets BTK, which stands for Bruton's tyrosine kinase. It is a BTK inhibitor, meaning it works by blocking the activity of this enzyme, which is involved in the growth and survival of malignant B cells in Waldenstrom Macroglobulinemia.
Ibrutinib is being developed by Amgen Inc., a biopharmaceutical company. Amgen's stock is traded under the ticker symbol AMGN on the NASDAQ stock exchange.
Ibrutinib is currently in Phase 2 clinical trials for Waldenstrom Macroglobulinemia. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical evaluation.
Ibrutinib is being studied in a Phase 2 clinical trial with the identifier NCT04263480. This trial is comparing the efficacy and safety of carfilzomib in combination with ibrutinib versus ibrutinib alone in patients with Waldenstrom's Macroglobulinemia. The trial is active but not recruiting participants.
Ibrutinib is a distinct drug and is not known by any other names. It is being studied as a monotherapy and in combination with carfilzomib in the ongoing clinical trial for Waldenstrom Macroglobulinemia.