Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Ly… (NCT02242097) | Clinical Trial Compass
UnknownPhase 2
Ibrutinib After Intensive Induction in Treating Patients With Previously Untreated Mantle Cell Lymphoma
United States37 participantsStarted 2015-01-12
Plain-language summary
This study is being done to see whether or not a drug called ibrutinib can be given to patients with mantle cell lymphoma (MCL) as maintenance therapy after induction chemotherapy. This drug blocks an enzyme that affects how the lymphocytes grow and survive. The investigators hope to learn how safe and effective ibrutinib is for treating patients with MCL after responding to induction chemotherapy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must have histologically confirmed mantle cell lymphoma (MCL)
* Please note: Measurable disease is not required, but will be followed if it exists
* Patients must have received 4 or more cycles of one of the following prior systemic induction chemotherapy regimens:
* Rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunomycin), vincristine sulfate (Oncovin), prednisone (R-CHOP) (with or without alternating rituximab, dexamethasone, cytarabine \[ara-c\], cisplatin \[platinum\] \[R-DHAP\]) with or without autologous (auto) stem cell transplant (SCT)
* Hyper-cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride (adriamycin), dexamethasone (CVAD) with or without auto SCT
* Bendamustine + rituximab with or without auto SCT
* Please note:
* Patients who received combinations of the above regimens are not eligible for enrollment
* At the time of registration, patients must be at least 14 days out from last dose of cytotoxic chemotherapy, but no more than 90 days; if a patient underwent auto SCT, he/she must demonstrate engraftment (per treating investigator's discretion) and must meet all other hematological requirements as outlined below
* Patients must have achieved a response to induction chemotherapy (either CR or PR by Cheson 2007 criteria) and be without known progression
* Patients may have received prior radiotherapy
* Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) perfor…
What they're measuring
1
Determine the Progression-free Survival (PFS) Rate After 3 Years