Last reviewed · How we verify
ctDNA-Guided Mosunetuzumab Consolidation Therapy in Older Patients With Untreated DLBCL (GOLD)
Older patients with diffuse large B- cell lymphoma (DLBCL) do not have the same rates of disease control as younger patients and are at risk for toxicity. Identifying which patients might benefit from more therapy at the end of first-line treatment is important. The ability to measure small amounts of persistent lymphoma (circulating tumor DNA or ctDNA) might allow the investigators to risk stratify patients. If older patients have detectable ctDNA in the blood at the end of six cycles of polatuzumab vedotin, rituximab and dose-attentuated CHP chemotherapy, patients will receive a bispecific antibody called mosunetuzumab. The investigators hypothesize this will result in "clearing" the ctDNA from the blood and result in better disease control and outcomes for patients. The study will also measure the safety of this regimen and the impact on the function of these older patients utilizing a tool called the geriatric assessment.
Details
| Lead sponsor | Danielle Wallace |
|---|---|
| Phase | Phase 2 |
| Status | RECRUITING |
| Enrolment | 40 |
| Start date | 2025-09-04 |
| Completion | 2030-04 |
Conditions
- Diffuse Large B-Cell Lymphoma (DLBCL)
Interventions
- Mosunetuzumab
- ClonoSEQ
Primary outcomes
- ctDNA clearance rate after mosunetuzumab treatment — From the beginning to the end of mosunetuzumab treatment at 18 weeks
The primary endpoint of the trial is the ctDNA clearance rate after mosunetuzumab treatment among the subset of patients in a PET/CT CR but with ctDNA+ at the end of 6 cycles of R-pola-mini-CHP. The rate will be calculated as the number of subjects ctDNA- after mosunetuzumab treatment among all patients treated with mosunetuzumab as part of the Fleming two-stage design.
Countries
United States