Trial · NCT07021989

ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma

NCT07021989, Phase 2, Recruiting, Michael Spinner, MD

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma. Trials, record NCT07021989. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07021989

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: ctDNA-Guided Therapy for Relapsed/Refractory Hodgkin Lymphoma
NCT number: NCT07021989
Status: Recruiting
Phases: Phase 2
Enrollment: 38 participants, estimated
Lead sponsor: Michael Spinner, MD
Conditions: Hodgkin Lymphoma, Adult, Refractory Hodgkin Lymphoma, Classic Hodgkin Lymphoma
Interventions: Pembrolizumab, Non-investigational, involved site radiotherapy (ISRT), Gemcitabine, Vinorelbine, Liposomal Doxorubicin, Foresight CLARITY™ LDT, Pegfilgrastim, Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)/Computerized tomography (CT)
First posted: 2025-06-15
Last updated: 2026-10-20

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percentage of participants with a complete response	Up to 4 cycles (a cycle is 21 days)	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.
Secondary	Progression-free survival (PFS) rate for participants without Autologous Stem Cell Transplant (ASCT)	Up to 2 years	PFS rate is defined as the proportion of participants alive without disease from initiation of study therapy to progression or death by any cause, whichever occurs first for up to 2 years after participants receive study therapy and non-transplant consolidation. The censoring time for PFS will be the date of the last study assessment for progression. PFS will be analyzed descriptively using Kaplan-Meier methods.
Secondary	Overall Survival (OS) rate for participants without ASCT	Up to 2 years	OS rate is defined as the proportion of participants alive from initiation of study therapy to death by any cause for up to 2 years after participants receive study therapy and non-transplant consolidation. The censoring time for OS will be the date of the last study contact. OS will be analyzed descriptively using Kaplan-Meier methods.
Secondary	Overall PFS rate	Up to 2 years	Overall PFS rate is defined as proportion of participants alive without disease from initiation of study therapy to progression or death by any cause, whichever occurs first for up to 2 years after participants receive study therapy. The censoring time for PFS will be the date of the last study assessment for progression. PFS will be analyzed descriptively using Kaplan-Meier methods.
Secondary	Overall survival rate	Up to 2 years	OS rate is defined as the proportion of participants alive from initiation of study therapy to death by any cause for up to 2 years after participants receive study therapy. The censoring time for OS will be the date of the last study contact. OS will be analyzed descriptively using Kaplan-Meier methods.
Secondary	Proportion of participants undergoing ASCT	Up to 2 years	The proportion of participants undergoing ASCT is defined as the number of participants having received an autologous stem cell graft over the total number of participants.
Secondary	Percentage of participants with presence cHL ctDNA	Up to	The percentage of participants with the presence of absence of detectable ctDNA through 2 cycles of pembrolizumab (pembro) + GVD will be reported.
Secondary	Percentage of participants with presence of detectable metabolically active disease	Up to 2 years	The percentage of participants with the presence of absence of detectable metabolically active disease on an FDG PET/CT at any time during the course of treatment with Pembro+GVD will be reported.
Secondary	Number of participants reporting treatment-emergent Adverse Events (AEs) of significant interest	From start of treatment until 90 days after discontinuation of treatment, approximately 2 years	The number of participants reporting Adverse Events (AEs) will be descriptive and performed based on the safety population. Serious Adverse Events (SAEs), Immune-related Adverse Events (irAEs), AEs classified as Grade 3 or higher per NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5, and AEs resulting in discontinuation of treatment, withdrawal from the study will be tabulated.
Secondary	Change in mean scores on the Patient Reported Outcomes Measurement Information System (PROMIS®-29) (Version 2) over time	Up to 5 years	The PROMIS 29 v2.0 profile assesses pain intensity using a response scale for each item ranging from 0 (no pain) to 10 (worst imaginable pain) on seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance), with four items per domain and one question which addresses pain intensity item. PROMIS-29 domains are scored using a T-score metric, with higher scores indicate higher levels of functioning. Mean scores and standard deviations will be reported.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41698326	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07021989

GET https://conductscience.org/api/trials/v1/NCT07021989/registered

API reference For AI assistants