Ibrutinib With Rituximab and Lenalidomide for Patients With Recurrent/Refractory Primary or Secon… (NCT03703167) | Clinical Trial Compass
CompletedPhase 1
Ibrutinib With Rituximab and Lenalidomide for Patients With Recurrent/Refractory Primary or Secondary Central Nervous System Lymphoma (PCNSL/SCNSL)
United States25 participantsStarted 2019-01-22
Plain-language summary
The investigator's want to find out if treatment with ibrutinib, rituximab, and lenalidomide are safe and better than the usual approach in patients with recurrent or refractory central nervous system lymphoma.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participants must be able to understand and be willing to sign a written informed consent document.
* Men and woman who are at least 18 years of age on the day of consenting to the study.
* Histologically documented PCNSL or histologically documented systemic diffuse large B-cell lymphoma (DLBCL).
* Patients must have relapsed/refractory PCNSL or relapsed/refractory SCNSL
* All patients need to have received at least one prior CNS directed therapy. There is no restriction on the number of recurrences.
* Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head CT) 21 days prior to study registration. For patients with leptomeningeal disease only, CSF cytology must document lymphoma cells and/or imaging findings consistent with CSF disease 21 days prior to study registration (at the discretion of the investigator).
* Participants must have an ECOG performance status of 0, 1, or 2.
* Participants must have adequate bone marrow and organ function shown by:
* Absolute neutrophil count (ANC) ≥ 1.0 x 10\^9/L
* Platelets ≥ 75 x 10\^9/L and no platelet transfusion within the past 21 days prior to study registration
* Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 21 days prior to study registration
* International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal
* Alanine aminotransferase (ALT) and aspartate aminotran…