Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07021989 | ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma | PHASE2 | NOT YET_RECRUITING | 38 | — | — | Jul 1, 2026 | Dec 31, 2033 | Jun 4, 2026 | 6 | United States |
To determine the ctDNA/MRD negative, PET negative complete response rate for cHL, participants undergoing treatment with pembro + GVD will have a composite response incorporating the following two criteria: (1) Absence of detectable cHL ctDNA as assessed by Foresight CLARITY LDT after 2 cycles of treatment and (2) complete response by Fluorodeoxyglucose (FDG) PET/CT, assessed by Lugano criteria after 2 cycles, or 4 if participant demonstrates indeterminate response (IR) after 2 cycles. Lugano classification for response using FDG PET-CT is as follows: A score is given which ranges from 1 (No uptake above background) to 5 (Hottest area of uptake markedly \> liver and/or new lesions present). A CR is defined as a score of 1,2,3 in nodal or extranodal sites with or without a residual mass. Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) will be used to distinguish IR, SD or PD. Response rate will be summarized by percentage, along with 95% confidence intervals.
| Arm | Type | Description |
|---|---|---|
| Treatment (Pembrolizumab + GVD) | EXPERIMENTAL | All participants receive 2, 21-day cycles of 200 mg Pembrolizumab (pembro) on day 1 of each cycle (pembro) and 1000mg Gemcitabine, 20mg/m\^2 of Vinorelbine, Liposomal doxorubicin 15 mg/m2 (GVD) on days 1 and 8 of each cycle for up to 2 cycles. Pegfilgrastim is administered on day 8 or 9 of each cycle. FDG-PET/CT imaging and Foresight CLARITY LDT ctDNA response after 2 cycles will determine if participants are eligible for an additional 2 cycles of pembro + GVD or salvage therapy and ASCT. Participants may be able to qualify for consolidation without ASCT (pembro and/or 30 Gy ISRT) depending on response. Radiographic response after 4 cycles will be conducted to determine eligibility for consolidation without ASCT for participants with CR or standard of care salvage therapy and ASCT, for participants with partial response (PR), stable disease (SD), or progressive disease (PD) after a second administration of pembro+GVD. Participants are followed for up to 5 years. |
| Name | Type | Description |
|---|---|---|
| Pembrolizumab | DRUG | Given intravenously |
| Non-investigational, involved site radiotherapy (ISRT) | RADIATION | Undergo possible, standard of care, non-investigational radiation therapy |
| Gemcitabine | DRUG | Given IV |
| Vinorelbine | DRUG | Given IV |
| Liposomal Doxorubicin | DRUG | Given IV |
| Foresight CLARITY™ LDT | DEVICE | Foresight CLARITY LDT, a laboratory-developed test (LDT),by Foresight Diagnostics, is an ultra-sensitive liquid biopsy and tissue platform that detects MRD in patients with B-cell lymphomas |
| Pegfilgrastim | DRUG | Given IV for supportive care |
| Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT) | PROCEDURE | Undergo imaging |
Inclusion Criteria: 1. Age ≥ 18 years. 2. Histologically confirmed classic Hodgkin lymphoma (including nodular sclerosis, lymphocyte-rich, mixed cellularity, and lymphocyte-depleted Hodgkin lymphoma). 3. Participants must have relapsed or refractory disease after no more than one line of systemic t...