Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Ibrutinib · 1 trial · 1 indication
Define maximum tolerated dose (MTD) and /or recommended phase II dose for the combinations of Bruton's Tyrosine Kinase (BTK) Inhibitor, Ibrutinib (PCI-32765) plus lenalidomide / rituximab in relapsed or refractory MCL by assessing the incidence of dose limiting toxicities (DLTs) in cycle 1 through an assessment of adverse events
| Arm | Type | Description |
|---|---|---|
| Dose Escalation Study | EXPERIMENTAL | Ibrutinib 560 mg/daily rituximab 375mg/m2 IV Day 1 Lenalidomide 10-25 mg PO days 1-21 |
| Name | Type | Description |
|---|---|---|
| Lenalidomide | DRUG | Dose escalation of lenalidomide. Patients will receive 10, 15, 20, or 25 mg PO days 1-21 |
| Ibrutinib | DRUG | 560 mg PO daily |
| Rituximab | DRUG | 375 mg/m2 IV Day 1 |
Inclusion Criteria: * Age greater than or equal to 18 years. * Histologically or cytologically confirmed diagnosis of MCL. * Relapsed or refractory MCL patients who have received at least one prior therapy are eligible. Patients who have previously received high-dose chemotherapy with peripheral st...
Ibrutinib is a small molecule kinase inhibitor being studied for the treatment of Mantle Cell Lymphoma. It is currently in Phase 1 clinical development as an investigational therapy for this condition. The drug is being evaluated in patients with relapsed or refractory Mantle Cell Lymphoma.
Ibrutinib is a kinase inhibitor, belonging to the -tinib class of drugs. It works by targeting kinases, which are enzymes involved in cell signaling and growth. This mechanism is being investigated for its potential role in treating Mantle Cell Lymphoma.
Ibrutinib is being developed by Meridian Bioscience Inc, a company traded under the ticker symbol VIVO. The company is conducting clinical research on this drug for the treatment of Mantle Cell Lymphoma.
Ibrutinib is currently in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is studying the drug in patients with relapsed or refractory Mantle Cell Lymphoma.
Ibrutinib is being studied in a Phase 1 clinical trial with the identifier NCT02446236. The trial is titled 'Dose Finding Study of Ibrutinib Plus Lenalidomide / Rituximab in Relapsed or Refractory Mantle Cell Lymphoma' and is actively recruiting participants in the United States. The study is uncontrolled and not blinded.
Ibrutinib is also known by other names, though specific alternative names are not provided. It is being investigated as a combination therapy with lenalidomide and rituximab in the ongoing clinical trial for Mantle Cell Lymphoma.