Polatuzumab Vedotin, Rituximab, Ifosfamide, Carboplatin, and Etoposide (PolaR-ICE) as Initial Salvage Therapy for the Treatment of Relapsed/Refractory Diffuse Large B-Cell Lymphoma
NCT04665765 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 41
Last updated 2025-09-03
Summary
This phase II trial studies the effect of polatuzumab vedotin, rituximab, ifosfamide, carboplatin, and etoposide as initial salvage therapy in treating patients with diffuse large B-cell lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79b positive cancer cells in a targeted way and delivers vedotin to kill them. Rituximab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs, such as ifosfamide, carboplatin, and etoposide, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving chemotherapy with immunotherapy may kill more cancer cells in patients with diffuse large B-cell lymphoma.
Conditions
- Diffuse Large B-Cell Lymphoma Unclassifiable
- Recurrent Diffuse Large B-Cell Lymphoma
- Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
- Recurrent Transformed B-Cell Non-Hodgkin Lymphoma
- Refractory Diffuse Large B-Cell Lymphoma
- Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
- Refractory Transformed B-Cell Non-Hodgkin Lymphoma
Interventions
- DRUG
-
Given IV
- DRUG
-
Etoposide
Given IV
- DRUG
-
Ifosfamide
Given IV
- DRUG
-
Polatuzumab Vedotin
Given IV
- BIOLOGICAL
-
Given IV
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
City of Hope Medical Center
lead OTHER
Principal Investigators
-
Alex F Herrera · City of Hope Medical Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-01-18
- Primary Completion
- 2022-07-26
- Completion
- 2026-07-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
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