Mosunetuzumab and Polatuzumab Vedotin With Split-Dose CHP Chemotherapy for Elderly Patients With Diffuse Large B-Cell Lymphoma

Part of paid clinical trials in Milwaukee, Wisconsin.

Sponsor
Medical College of Wisconsin
Study ID
NCT06594939
Phase
PHASE2
Status
Recruiting
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Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    A combination of a monoclonal antibody and a chemotherapy drug.
  • Mosunetuzumab — DRUG
    A monoclonal antibody.
  • Cyclophosphamide — DRUG
    Chemotherapy drug, alkylating agent.
  • Doxorubicin — DRUG
    Chemotherapy drug, anthracycline antibiotic.
  • Prednisone — DRUG
    Steroid, anti-inflammatory
  • Pegfilgrastim — OTHER
    Granulocyte stimulating factor, biologic response modifier.

Study Details

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.

Key Dates

First listed
Sep 19, 2024
Start date
Jun 1, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
31 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Mosum-Pola-SD-CHP
    Each cycle is 28 days and consists of one "A" treatment on Day 1 and one "B" treatment on Day 15 for six cycles. Day 1 ("A" part of cycle) Polatuzumab Vedotin 1.8 mg/kg Intravenous (IV); Mosunetuzumab (Cycle 1A) 5 mg Subcutaneous (SC); Cyclophosphamide 375 mg/m\^2 IV; Doxorubicin 25 mg/m\^2 IV; Prednisone 50 mg Orally Day 2 ("A" part of cycle) Pegfilgrastim 6 mg SC Day 8 ("A" part of cycle) Mosunetuzumab 45 mg SC Day 15 ("B" part of cycle) Mosunetuzumab (Cycle 1B-6B) 45 mg SC; Cyclophosphamide 375 mg/m\^2 IV; Doxorubicin 25 mg/m\^2 IV; Prednisone 50 mg Orally Day 16 ("B" part of cycle) Pegfilgrastim 6 mg SC

Primary Outcome Measure

Complete Response [ Time Frame: Up to six months. ]

Central Contacts

  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505
    [email protected]
  • Medical College of Wisconsin Cancer Center Clinical Trials Office
    866-680-0505

Locations (1)

FacilityCityStateZIPSite coordinators
Froedtert Hospital & the Medical College of WisconsinMilwaukeeWisconsin53226
Nirav Shah, MD
[email protected]
414-805-4600

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By research site
Froedtert Hospital & the Medical College of Wisconsin· Milwaukee, WI

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