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NCT05404945 · ClinicalTrials.gov registry record · Phase 2
Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above
A Phase 2 study of Classical Hodgkin Lymphoma, sponsored by University of Virginia.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 44
- Enrollment target
- 3
- Study locations
NCT05404945 is a Phase 2 study of Classical Hodgkin Lymphoma that is actively recruiting participants, run by University of Virginia. The registered enrollment target is 44 participants, below the 74-participant average among 8 other Classical Hodgkin Lymphoma trials with a reported enrollment target (41% lower). The trial reports 3 study locations across 3 states.
The verdict
NCT05404945, a Phase 2 study of Classical Hodgkin Lymphoma, is actively recruiting participants, sponsored by University of Virginia.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 44 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a multi-center, open-label phase II study to assess the efficacy of a novel fitness-adapted regimen in previously untreated older patients with classical Hodgkin lymphoma. All participants will receive up to a total of 8 cycles of pembrolizumab (Q6 week dosing). The first cycle of pembrolizumab will be administered in combination with brentuximab vedotin (BV) ("lead-in treatment"). Following lead-in treatment, all participants will undergo interim PET/CT (iPET) as well as fitness testing to help inform participant level of fitness for subsequent lymphoma-directed therapies. Participants deemed "Frail" by this assessment will continue 3 additional 6 week cycles of concurrent pembrolizumab and BV ("induction therapy", each cycle is 42 days), then continue single-agent pembrolizumab to complete up to 4 additional cycles (i.e., 8 total) of therapy ("consolidation and maintenance therapy", Frail cohort). Two additional BV doses will be given as consolidation, at days 1 and 22 of pembrolizumab cycle 5. Those deemed "fit" after lead-in therapy (Fit cohort) will continue pembrolizumab and switch from BV to concurrently-administered combination chemotherapy using doxorubicin (A), vinblastine (V), and dacarbazine (D) for a total of 4 planned AVD cycles (3, 6-week pembrolizumab cycles, "induction therapy"). Chemotherapy drugs will be given at standard doses as in ABVD (no bleomycin will be given in this study) on days 1 and 15 of each 28-day cycle (C1AVD), and pembrolizumab dosing will remain every 42 days. Following end-induction PET/CT, pembrolizumab will continue every 42 days for up to 4 cycles in the consolidation/maintenance phase. Two additional BV doses will be given as consolidation, at days 1 and 22 of pembrolizumab cycle 5. Participants deemed "unfit" after lead-in therapy and by fitness assessment will continue pembrolizumab and switch from BV to concurrently administered combination chemotherapy termed "mini-avd" as induction therapy. Mini-avd consists
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG Doxorubicin
- DRUG Brentuximab vedotin
- DRUG Dacarbazine
- DRUG Vinblastine
Study Locations (3)
New Jersey
- Rutgers Cancer Institute of New Jersey - New Brunswick
Pennsylvania
- University of Pennsylvania - Philadelphia
Virginia
- University of Virginia - Charlottesville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2022-07-26 |
| Est. Completion | 2027-10-03 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05404945
The ClinicalTrials.gov registry entry for NCT05404945 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 74-participant average among 8 other Classical Hodgkin Lymphoma trials with a reported enrollment target (41% lower). The listed sponsor is University of Virginia, which has 449 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Classical Hodgkin Lymphoma appearing as the primary indexed condition, and to 5 interventions - of which Pembrolizumab is the first listed.
NCT05404945 reports 3 study locations spanning 3 distinct geographic areas - top geographies include New Jersey, Pennsylvania, Virginia.
Frequently Asked Questions
What is clinical trial NCT05404945 about?
NCT05404945 is a clinical study titled "Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above". This is a multi-center, open-label phase II study to assess the efficacy of a novel fitness-adapted regimen in previously untreated older patients with classical Hodgkin lymphoma. All participants will receive up to a total of 8 cycles of pembrolizumab (Q6 week dosing). The first cycle of pembrolizu...
What is the current status of trial NCT05404945?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 44 participants. The study started on 2022-07-26. Estimated completion is 2027-10-03.
What conditions does trial NCT05404945 study?
This clinical trial studies the following conditions: Classical Hodgkin Lymphoma.
What interventions are being tested in trial NCT05404945?
The interventions under investigation include: Pembrolizumab (DRUG), Doxorubicin (DRUG), Brentuximab vedotin (DRUG), Dacarbazine (DRUG), Vinblastine (DRUG).
Who is sponsoring clinical trial NCT05404945?
This trial is sponsored by University of Virginia, which has 449 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05404945 being conducted?
This trial has 3 study locations across New Jersey, Pennsylvania, Virginia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.