Multicenter Phase II Study of Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma
Medical College of Wisconsin
Summary
This single-arm, interventional phase 2 study is designed to evaluate whether the inclusion of mosunetuzumab subcutaneous and polatuzumab vedotin (Mosun-Pola) to a split-dose CHP chemotherapy backbone will improve outcomes for elderly patients with a new diagnosis of diffuse large B-cell lymphoma.
Description
This trial combines two novel agents, mosunetuzumab subcutatneous and polatuzumab vedotin (Mosun-Pola), with cytotoxic chemotherapy while allowing de-escalation in rapidly responding patients. After completing the first two cycles of Mosun-Pola-SD-CHP therapy, subjects will undergo an interim response assessment with positron emission tomography (PET) / computed tomography (CT) and minimal residual disease (MRD) testing (ClonoSEQ; Adaptive Biotechnology) prior to Cycle 3A. Patients who are interim PET-negative and MRD-negative will be placed on an abbreviated treatment regimen, where they will…
Eligibility
- Age range
- 70+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Patients aged 70-74 who are determined to be unfit or frail by the Cumulative Illness Rating Scale-Geriatric (CIRS-G) score with 5-8 comorbid conditions scored 2 or more than 1 comorbidity scored 3-4 are allowed. 2. Newly diagnosed, untreated, biopsy-proven CD20 positive diffuse large B-cell lymphoma (DLBCL) (including high-grade B-cell lymphoma and T-cell/histiocyte-rich large B-cell lymphoma). Patients with discordant bone marrow (i.e., involved by low-grade/indolent non-Hodgkin lymphoma) are eligible. Patients with transformed DLBCL from underlying low-grade disease…
Interventions
- DrugPolatuzumab Vedotin
A combination of a monoclonal antibody and a chemotherapy drug.
- DrugMosunetuzumab
A monoclonal antibody.
- DrugCyclophosphamide
Chemotherapy drug, alkylating agent.
- DrugDoxorubicin
Chemotherapy drug, anthracycline antibiotic.
- DrugPrednisone
Steroid, anti-inflammatory
- OtherPegfilgrastim
Granulocyte stimulating factor, biologic response modifier.
Location
- Froedtert Hospital & the Medical College of WisconsinMilwaukee, Wisconsin