Treatment Study for Relapsed/Refractory Diffuse Large B-Cell Lymphoma
The purpose of this study is to evaluate the safety and efficacy of denintuzumab mafodotin plus RICE (rituximab, ifosfamide, carboplatin, and etoposide) when compared to RICE alone in the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or Grade 3b follicular lymphoma. Eligible patients must also be candidates for autologous stem cell transplant. Patients will be randomly assigned to receive 3 cycles of study treatment with denintuzumab mafodotin + RICE or RICE alone. The study will assess whether there is a difference between the 2 groups in the side effects that are reported and the number of patients who achieve complete remission at the end of their study treatment.
In order to participate you must meet the following criteria:
- Have a confirmed diagnosis of CD20-positive relapsed or refractory diffuse large B-cell lymphoma (DLBCL; including de novo and transformed DLBCL) or Grade 3b follicular lymphoma.
- Have received only frontline CD20-directed immunotherapy with anthracycline- or anthracenedione-based multi-agent chemotherapy.
- Are considered eligible for high-dose chemotherapy followed by autologous stem cell transplant (ASCT).
- Have adequate kidney and blood function assessed from laboratory data.
You will be excluded from the study if any of the following criteria apply to you:
- Have a history of indolent lymphoma treated with more than one multi-agent chemotherapy regimen or previous cancer therapy for recurrent DLBCL or Grade 3b follicular lymphoma.
- Have a history of autologous or allogeneic stem cell transplant.
- Have a history of another primary invasive cancer, hematologic malignancy, or myelodysplastic syndrome that has not been in remission for at least one year.
- Have a history of progressive multifocal leukoencephalopathy (PML).
- Have one or more of the following ocular conditions: corneal disorders, monocular vision (best corrected visual acuity greater than or equal to 20/200 in one eye), or active ocular disorders requiring treatment.
This is a partial list of elgibility requirements.