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NCT06828991 · ClinicalTrials.gov registry record · Phase 2
A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP
A Phase 2 study of Diffuse Large B Cell Lymphoma (DLBCL), sponsored by Danielle Wallace.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 1
- Study location
NCT06828991: Recruiting Phase 2 study of Diffuse Large B Cell Lymphoma (DLBCL), sponsored by Danielle Wallace.
NCT06828991 is a Phase 2 study of Diffuse Large B Cell Lymphoma (DLBCL) that is actively recruiting participants, run by Danielle Wallace. The registered enrollment target is 40 participants, below the 259-participant average among 10 other Diffuse Large B Cell Lymphoma (DLBCL) trials with a reported enrollment target (85% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06828991, a Phase 2 study of Diffuse Large B Cell Lymphoma (DLBCL), is actively recruiting participants, sponsored by Danielle Wallace.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Mosunetuzumab
- DEVICE ClonoSEQ
Study Locations (1)
New York
- Wilmot Cancer Institute - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-09-04 |
| Est. Completion | 2030-04 |
| Phase | Phase 2 |
What NCT06828991 shows while recruiting
NCT06828991 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 259-participant average among 10 other Diffuse Large B Cell Lymphoma (DLBCL) trials with a reported enrollment target (85% lower).
The record links to 1 condition, with Diffuse Large B Cell Lymphoma (DLBCL) appearing as the primary indexed condition, and to 2 interventions - of which Mosunetuzumab is the first listed.
NCT06828991 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06828991 about?
NCT06828991 is a clinical study titled "A Study to Evaluate the Impact of Mosunetuzumab Consolidation for Older Patients With Diffuse Large B-cell Lymphoma (DLBCL) Who Have Detectable Amounts of ctDNA (Circulating Tumor DNA) at the End of Treatment With Pola-R-mini-CHP". 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 ...
What is the current status of trial NCT06828991?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-09-04. Estimated completion is 2030-04.
What conditions does trial NCT06828991 study?
This clinical trial studies the following conditions: Diffuse Large B Cell Lymphoma (DLBCL).
What interventions are being tested in trial NCT06828991?
The interventions under investigation include: Mosunetuzumab (DRUG), ClonoSEQ (DEVICE).
Who is sponsoring clinical trial NCT06828991?
This trial is sponsored by Danielle Wallace, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06828991 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06828991's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
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