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 range18 Years – 99 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

✓. 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.
✓. 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.

What they're measuring

Rate of complete remission

Timeframe: 12 months

Trial details

NCT IDNCT02682641

SponsorGrupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-12

View on ClinicalTrials.gov More Mantle Cell Lymphoma trials