Send yourself the details of this trial and next steps
Please provide a valid email address.
Send yourself the details of this trial and next steps
Please provide a valid email address.
This doesn't look like a valid phone number. Please check.
Both First Name and Last Name are required. Please check.
Home»Non-Hodgkin lymphoma» Looking for patients with diffuse large B-cell lymphoma or stage 3b follicular lymphoma to test an antibody-drug conjugate with chemotherapy
Clinical Trial
Looking for patients with diffuse large B-cell lymphoma or stage 3b follicular lymphoma to test an antibody-drug conjugate with chemotherapy
This phase 2 clinical trial will determine the effectiveness of denintuzumab mafodotin (SGN-CD19A) with RICE chemotherapy in patients with relapsed or refractory (unresponsive to treatment) diffuse large B-cell lymphoma (DLBCL) or stage 3b follicular lymphoma (FL). The primary outcome will be measured by the complete remission rate.
The details
Denintuzumab mafodotin is an antibody (a protein in the immune system) that delivers an attached drug specifically to cancerous B-cells. The antibody is designed to bind to a protein found on some cancerous B-cells. Once bound, the antibody will be taken into the cancer cell where the drug will be released and disrupt cell division, resulting in cell death. This drug intends to provide a more cancer-specific treatment that reduces harm to healthy cells, which would decrease the number of adverse (negative) effects. RICE chemotherapy is a combination chemotherapy commonly used to treat non-Hodgkin’s lymphomas. It includes the treatments rituximab (Rituxan), ifosfamide (Ifex), carboplatin (Paraplatin), and etoposide (Etopophos).
The study will examine the complete remission rate in patients treated with denintuzumab mafodotin. It will also consider the response to treatment, time to disease progression, overall survival, and number of patients that can undergo stem cell transplants.
Who are they looking for?
This trial is recruiting 150 patients with DLBCL or stage 3b FL. Patients should have only received one previous chemotherapy and/or immunotherapy and should be considered eligible for high-dose chemotherapy followed by autologous stem cell transplant (from the patient’s own stem cells). Patients with a history of previous malignancies should be disease free for at least 1 year. Patients should not have cancer spread to the brain, urinary tract obstruction, or certain eye disorders.
How will it work
Patients will be randomly divided into two groups. One group will receive denintuzumab mafodotin with the RICE chemotherapy. The other group will receive only RICE chemotherapy. All drugs will be delivered intravenously (through IV into a vein) every 3 weeks for 3 cycles.
