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Home»Non-Hodgkin lymphoma» Looking for patients with relapsed or refractory diffuse large B-cell lymphoma to test the effective of ibrutinib during and following stem cell transplant
Clinical Trial
Looking for patients with relapsed or refractory diffuse large B-cell lymphoma to test the effective of ibrutinib during and following stem cell transplant
This phase 3 clinical trial will test the effectiveness of ibrutinib(Imbruvica) during and after stem cell transplant in patients with relapsed or refractory diffuse large B-cell lymphoma. The primary outcome will be measured by the time to disease progression.
The details
Ibrutinibis a drug that stops the growth of B-cells and spread of lymphoma. It binds to the Bruton's tyrosine kinase (BTK), a protein essential for B-cell growth and development. BTKs are often overexpressed in B-cell cancers, which leads to uncontrolled B-cell growth. Ibrutinib, in addition to a chemotherapy, before and after stem cell transplantation may improve outcomes.
The study will examine the proportion of patients who are progression free after 2 years, overall survival, side effects, and incidence of another cancer.
Who are they looking for?
This trial is recruiting 302 patients with relapsed or refractory diffuse large B-cell lymphoma. Patients must have progressed or not responded to an anthracycline chemotherapy. Patients should have normal to near normal blood values.
Participants cannot have central nervous system (CNS) involvement with lymphoma or myelodysplasia. Ideal candidates should not have major surgery at least 7 days prior or minor surgery 3 days prior to enrollment. Patients cannot have had a stroke or hemorrhage less than 6 months before entry.
How will it work
Patients will be randomly placed into an experimental group or a placebo (substance with no active effect) group. Patients will be assigned to either BEAMi or CBVi chemotherapy combinations.
BEAMi patients will receive ibrutinib(or a placebo) by mouth on days -6 to -1 before transplant, carmustine intravenously (through IV) for 2 hours on day -6, etoposide intravenously twice for 1-2 hours, and cytarabine intravenously twice for 1-2 hours on days -5 to -2, and melphalan intravenously for 20-30 minutes on day -1.
CBVi patients will receive ibrutinib(or placebo) by mouth on days -6 to -1, carmustine intravenously for 2 hours on day -6, etoposide intravenously for 4 hours on day -4 and cyclophosphamide intravenously on day -2.
All patients will undergo a bone marrow or HSC transplant on day 0. 30-36 days after the treatment, patients will begin taking ibrutinib (or placebo) on days 1-28 over a 28-day cycle for 12 cycles.
