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New tailored therapy offers hope for older hodgkin lymphoma patients

NCT ID NCT05404945

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a treatment plan that adjusts chemotherapy based on a patient's fitness level for adults aged 60 and older with untreated classical Hodgkin lymphoma. All participants receive the immunotherapy drug pembrolizumab plus another targeted drug, then a PET scan and fitness test decide if they get standard, reduced, or no chemotherapy. The goal is to improve remission rates while reducing side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2022

Expected to finish

Oct 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

60 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. * Participants who have received involved field radiation will be allowed. However, they will be excluded if any of the following are true: 1. Radiation was dosed ≤6 months from registration. 2. Radiation was delivered to \> 1 lymph node group as defined by the NCCN criteria. 3. The radiation dose was ≥30 Gy. 4. The participant has radiation-related toxicities ≥ Grade 2 at the time of registration. 5. The participant requires corticosteroids for radiation-related toxicities at the time of registration (regardless of dose). 6. 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). Exclusion Criteria: * 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 * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08902-2681, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Virginia

    Charlottesville, Virginia, 22911, United States

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