Classical Hodgkin LymphomaPhase 2NCT05404945
Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above
A Phase 2 study testing Pembrolizumab, Doxorubicin and Vinblastine in people with Classical Hodgkin Lymphoma, run by University of Virginia at 3 sites in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Classical Hodgkin Lymphoma
- What is being tested?
- Pembrolizumab, Doxorubicin and Vinblastine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 3 sitesUnited States
- Study dates
- 26 Jul 2022to 3 Oct 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants of any sex who are ≥60 years of age on day 1, cycle 1.
- The participant must be willing and able to provide written informed consent for the trial and participate in all planned study procedures.
- Histologically confirmed diagnosis of classical Hodgkin lymphoma
- PET-avid, measurable disease (≥1.5cm bi-dimensional measurement)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to
- PS 2 may be allowed at the discretion of the treating investigator if impairment is considered to be primarily lymphoma-related. Evaluation of ECOG is to be performed within 10 days prior to the date of registration.
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- Participants who have received involved field radiation will be allowed. However, they will be excluded if any of the following are true:
- Radiation was dosed ≤6 months from registration.
- Radiation was delivered to > 1 lymph node group as defined by the NCCN criteria.
- The radiation dose was ≥30 Gy.
- The participant has radiation-related toxicities ≥ Grade 2 at the time of registration.
- The participant requires corticosteroids for radiation-related toxicities at the time of registration (regardless of dose).
- The participant has ever experienced radiation pneumonitis.
- Have adequate organ function as defined per protocol. Specimens must be collected within 10 days prior to registration (confirmation of eligibility).
Who cannot join
- Nodular lymphocyte-predominant Hodgkin lymphoma
- Life expectancy < 6 months for any reason excluding lymphoma
- Has received prior therapy with an immune checkpoint inhibitor, against targets including but not limited to PD1, PDL1, PDL2, CTLA-4, OX40, or LAG 3 unless given with curative intent for reasons other than lymphoma AND the last dose was more than 3 years from registration. Any participant who received prior immune checkpoint inhibitor therapy will be excluded if they experienced any toxicity related to or possibly related to the immunotherapy that required discontinuation of drug.
- Prior systemic therapy for cHL, with the exception of steroids
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
- Presence of Grade ≥ 2 sensory and/or motor neuropathy
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- Prior solid organ or stem cell transplant.
- Clinical suspicion or evidence of active involvement of lymphoma into the spinal cord, cerebral spinal fluid, or brain. External compression of the spinal cord or nerve roots is not considered involvement.
- Has received a live vaccine or live-attenuated vaccine within 30 days prior to the first dose of study drug. Administration of killed vaccines, subunit vaccines, and nucleic acid vaccines is allowed.
- Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
- Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
- Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent [excluding steroids needed for lymphoma related symptoms]) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.
- Known additional malignancy that is progressing or has required active treatment within the past 3 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (excluding carcinoma in situ of the bladder) that have undergone potentially curative therapy are not excluded.
- Has known severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
- Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
- Interstitial lung disease or a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- Any known history of pancreatitis as defined by Gandhi et al. 201432,36.
- Has an active infection requiring oral or intravenous systemic therapy.
- Has a known history of Human Immunodeficiency Virus (HIV).
- Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection. Prior exposure to hepatitis B is allowed as long as there are no HBsAg detected (ie positive Hepatitis B core antibody with negative HBsAg). Prior treatment with Hepatitis C is allowed if the screening HCV RNA by PCR is negative.
- Has a known history of active tuberculosis (TB; Mycobacterium tuberculosis).
- Is currently taking a strong CYP3A4 modulator. Subjects taking strong CYP34A modulators that can safely stop these medications prior to treatment should complete a washout period of 4 weeks or 5 times the half-life of a particular drug, whichever is shorter.
- Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the treating investigator.
- Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
- Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.
- Note: given older age at enrollment, WOCBP are not anticipated to enroll on this study.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Virginia
Charlottesville, Virginia, 22911
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08902-2681
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above (cHL 001)
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.
Read more
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 of lower doses of conventional AVD chemotherapy (doxorubicin, vinblastine and dacarbazine) and will be administered for on days 1 and 15 of a 28 day cycle for 4 planned cycles. Pembrolizumab will continue 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.
- Conditions
- Classical Hodgkin Lymphoma
- Being tested
- Pembrolizumab, Doxorubicin, Vinblastine, Dacarbazine, Brentuximab vedotin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Pembrolizumab 400 mg IV
DoxorubicinDrug
Also called Adriamycin
Doxorubicin 25mg/m2 IV
VinblastineDrug
Vinblastine 6mg/m2 IV
DacarbazineDrug
Dacarbazine 375mg/m2 IV
Brentuximab vedotinDrug
Brentuximab vedotin 1.8 mg/kg IV
| Study group | Role | What they receive |
|---|---|---|
| Fit Cohort | Experimental | Three 6-week cycles of 400 mg intravenous pembrolizumab + intravenous AVD (q 2 weeks). Receives: Drug: Pembrolizumab; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Brentuximab vedotin |
| Frail Cohort | Active comparator | Three 6-week cycles of 400 mg intravenous pembrolizumab and concurrent (q 3 week) intravenous brentuximab vedotin (BV). Receives: Drug: Pembrolizumab; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Brentuximab vedotin |
| Unfit Cohort | Active comparator | Three 6-week cycles of 400 mg intravenous pembrolizumab and mini-AVD (q 2 weeks). Receives: Drug: Pembrolizumab; Drug: Doxorubicin; Drug: Vinblastine; Drug: Dacarbazine; Drug: Brentuximab vedotin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete Remission Rate
Evaluate complete remission rate as defined by LYRIC criteria at end of induction in fit and unfit older participants with cHL following anthracycline-based chemotherapy.
Measured: 2 years
Incidence of grade 3-5 treatment-related AEs
Assess tolerance and safety of a fitness-adapted pembrolizumab-based regimen in fit older participants with cHL based on incidence of grade 3-5 treatment-related AEs (CTCAE v5.0)
Measured: 2 years
Secondary outcomes (4)
2-year PFS, 2-year OS, 2-year Lymphoma Specific Survival in the fit older population following pembrolizumab-based adaptive therapy
Evaluate the efficacy, as determined by the 2-year progression free survival (PFS), overall survival (OS), and 2-year lymphoma specific survival in the fit older population.
Measured: 2 years
Complete remission rate (by LYRIC criteria), 2-year PFS, 2-year OS, 2-year Lymphoma Specific Survival in the Frail older population
Evaluate the efficacy of a chemotherapy-free approach (pembrolizumab plus BV), as determined by the complete remission rate (LYRIC criteria), 2-year progression free survival (PFS), overall survival (OS), and 2-year lymphoma specific survival in participants who are not frail for anthracycline-based therapy.
Measured: 2 years
Complete remission rate (LYRIC criteria) after lead-in BV/pembrolizumab
Assess the efficacy of short course lead-in therapy and correlation with end-induction treatment efficacy for all participants.
Measured: 2 years
Incidence of grade 2-5 immune-related toxicities (CTCAE v5.0)
Assess safety, as determined by the frequency of higher-grade immune-related adverse events for all participants.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2022
- Study start26 Jul 2022
- Primary completion3 Oct 2027 (estimated)
- Study completion3 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Classical Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Responsible party
- Principal investigator, Craig A Portell, MD, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05404945
- Sponsor's protocol ID
- cHL001
- Status last verified
- May 2026
- First submitted
- 22 May 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fitness-adapted, Pembrolizumab-based Therapy for Untreated Classical Hodgkin Lymphoma Patients 60 Years of Age and Above (cHL 001)
- ClinicalTrials.gov ID
- NCT05404945
- Acronym / sponsor ID
- cHL001
- Conditions
- Classical Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- Merck Sharp & Dohme LLC
- Study start
- 26 Jul 2022 (actual)
- Primary completion
- 3 Oct 2027 (estimated)
- Study completion
- 3 Oct 2027 (estimated)
- First posted
- 3 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 of lower doses of conventional AVD chemotherapy (doxorubicin, vinblastine and dacarbazine) and will be administered for on days 1 and 15 of a 28 day cycle for 4 planned cycles. Pembrolizumab will continue 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Fit Cohort | Experimental | Drug: Pembrolizumab, Drug: Doxorubicin, Drug: Vinblastine, Drug: Dacarbazine, Drug: Brentuximab vedotinThree 6-week cycles of 400 mg intravenous pembrolizumab + intravenous AVD (q 2 weeks). |
| Frail Cohort | Active comparator | Drug: Pembrolizumab, Drug: Doxorubicin, Drug: Vinblastine, Drug: Dacarbazine, Drug: Brentuximab vedotinThree 6-week cycles of 400 mg intravenous pembrolizumab and concurrent (q 3 week) intravenous brentuximab vedotin (BV). |
| Unfit Cohort | Active comparator | Drug: Pembrolizumab, Drug: Doxorubicin, Drug: Vinblastine, Drug: Dacarbazine, Drug: Brentuximab vedotinThree 6-week cycles of 400 mg intravenous pembrolizumab and mini-AVD (q 2 weeks). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Participants of any sex who are ≥60 years of age on day 1, cycle 1.
- The participant must be willing and able to provide written informed consent for the trial and participate in all planned study procedures.
- Histologically confirmed diagnosis of classical Hodgkin lymphoma
- PET-avid, measurable disease (≥1.5cm bi-dimensional measurement)
- Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to
Key exclusion criteria (26 listed)
- Nodular lymphocyte-predominant Hodgkin lymphoma
- Life expectancy < 6 months for any reason excluding lymphoma
- Has received prior therapy with an immune checkpoint inhibitor, against targets including but not limited to PD1, PDL1, PDL2, CTLA-4, OX40, or LAG 3 unless given with curative intent for reasons other than lymphoma AND the last dose was more than 3 years from registration. Any participant who received prior immune checkpoint inhibitor therapy will be excluded if they experienced any toxicity related to or possibly related to the immunotherapy that required discontinuation of drug.
- Prior systemic therapy for cHL, with the exception of steroids
- If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabPembrolizumab 400 mg IV | Drug | Fit Cohort, Frail Cohort, Unfit Cohort |
| DoxorubicinAlso: AdriamycinDoxorubicin 25mg/m2 IV | Drug | Fit Cohort, Frail Cohort, Unfit Cohort |
| VinblastineVinblastine 6mg/m2 IV | Drug | Fit Cohort, Frail Cohort, Unfit Cohort |
| DacarbazineDacarbazine 375mg/m2 IV | Drug | Fit Cohort, Frail Cohort, Unfit Cohort |
| Brentuximab vedotinBrentuximab vedotin 1.8 mg/kg IV | Drug | Fit Cohort, Frail Cohort, Unfit Cohort |
Primary outcome
Complete Remission Rate
Time frame: 2 years
Evaluate complete remission rate as defined by LYRIC criteria at end of induction in fit and unfit older participants with cHL following anthracycline-based chemotherapy.
Incidence of grade 3-5 treatment-related AEs
Time frame: 2 years
Assess tolerance and safety of a fitness-adapted pembrolizumab-based regimen in fit older participants with cHL based on incidence of grade 3-5 treatment-related AEs (CTCAE v5.0)
4 secondary outcomes
2-year PFS, 2-year OS, 2-year Lymphoma Specific Survival in the fit older population following pembrolizumab-based adaptive therapy
Time frame: 2 years
Complete remission rate (by LYRIC criteria), 2-year PFS, 2-year OS, 2-year Lymphoma Specific Survival in the Frail older population
Time frame: 2 years
Complete remission rate (LYRIC criteria) after lead-in BV/pembrolizumab
Time frame: 2 years
Incidence of grade 2-5 immune-related toxicities (CTCAE v5.0)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Pembrolizumab, Doxorubicin and Vinblastine in people with Classical Hodgkin Lymphoma, run by University of Virginia at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete Remission Rate (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.