Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL (NCT02682641) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Ibrutinib in Combination With Rituximab in Patients With Indolent Clinical Forms of MCL
Spain50 participantsStarted 2016-05-18
Plain-language summary
Phase II study with a two-stage design to evaluate efficacy and safety of ibrutinib in combination with rituximab (I+R) in untreated patients with indolent clinical forms of MCL.
An extensive biological study will be conducted in order to further characterize this population of MCL patients and evaluate the response obtained with the mutational profile of the tumor.
Who can participate
Age range
18 Years – 99 Years
Sex
ALL
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
. Subjects with confirmed diagnosis of Mantle Cell Lymphoma (World Health Organization Classification, WHO 2008). Classical, small-cell variants and marginal-zone variants can be included.
. Age 18 years or older.
. Subjects must not have received any prior therapies (excluding diagnostic splenectomy).
. Asymptomatic patients.
. Ann Arbor clinical stages I-IV.
. Eastern Cooperative Oncology Group (ECOG) performance status \<2 (0-1).
. Subjects with a non-nodal MCL presentation with mainly bone marrow or peripheral blood involvement.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of complete remission
Timeframe: 12 months
Trial details
NCT IDNCT02682641
SponsorGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea
. Other asymptomatic clinical presentations are acceptable in case of low tumor burden, including nodal MCL with lymph node enlargement ≤3 cm in the maximum diameter and with low proliferation index (Ki-67 ≤ 30%).
Exclusion criteria
. Aggressive histological variants: blastic and pleomorphic variants (blastoid).
. Proliferation index measured by Ki-67 \> 30%.
. B-cell monoclonal lymphocytosis with MCL phenotype
. Eastern Cooperative Oncology Group (ECOG) performance status ≥2. Presence of B symptoms or any relevant symptoms related to the MCL.