New combo aims to cure hodgkin lymphoma without harsh chemo or transplant
NCT ID NCT03179917
First seen Jun 27, 2026 · Last updated Sep 03, 2026 · Updated 4 times
Summary
This study tests whether combining the drug pembrolizumab with a precise form of radiation can cure people with early-stage Hodgkin lymphoma that has returned or not responded to initial treatment. About 22 participants will receive this combination, with the goal of avoiding the need for more chemotherapy or a stem cell transplant. The main focus is on how many patients achieve a complete response.
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
-
22 people
The number who actually took part.
- Started
-
Jun 2017
- Expected to finish
-
Jun 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
-
12 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 Hide 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: * Three populations of patients are eligible for enrollment: (1) Patients with early stage disease at diagnosis (stage I-II) who were treated with chemotherapy alone and relapsed with early stage disease (stage RI-II). (2) Patients with early stage disease at diagnosis (stage I-II) who were treated with chemotherapy alone and have early stage (stage RI-II) primary refractory disease (residual disease on a scan 1 month after the completion of initial therapy) without B-symptoms and with each area of disease less than 10 cm in size. (3) Patients with early stage disease at diagnosis (stage I-II) who were treated with combined modality therapy (chemotherapy and radiation) who relapse with early stage disease (stage RI-II) outside the prior radiation therapy field. * Histologic confirmation of classical Hodgkin Lymphoma after imaging documenting primary refractory or relapsed disease * Age 12 or older * ECOG Performance Status of 0-1 or Lansky Performance Status of ≥ 50 (Pts 12-15 years of age) * Adequate organ function. Screening labs should be performed within 14 days of treatment initiation. Hematologic * Absolute neutrophil count (ANC) ≥1,000 /mcL * Platelets\* ≥75,000 / mcL * Hemoglobin\* ≥8 g/dL Renal * Creatinine OR Measured or calculated\*\* creatinine clearance CrCl (GFR can also be used in place of creatinine or ≤1.5 X upper limit of normal for age (ULN) OR ≥60 mL/min for subject with creatinine levels \> 1.5 X institutional ULN Hepatic * Total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels \>1.5 ULN * AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for age for subjects with liver involvement Coagulation International Normalized Ratio (INR) or Prothrombin Time (PT) Activated Partial Thromboplastin Time (aPTT) ≤1.5 X ULN unless subject is receiving anticoagulant therapy, then as long as PT or PTT is within therapeutic range of intended use of anticoagulants * 1.5 X ULN unless subject is receiving anticoagulant therapy, then as long as PT or PTT is within therapeutic range of intended use of anticoagulants \* Hemoglobin and platelet requirements cannot be met by use of recent transfusion or growth factor support (GCSF or erythropoietin) within 2 weeks prior to treatment initiation. * Creatinine clearance should be calculated per institutional standard. * Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from sexual activity for the course of the study through 120 days after the last dose of study medication (Reference Section 5.7.2). Subjects of child bearing potential are those who have not been surgically sterilized or have not been free from menses for \> 1 year. Note: Abstinence is acceptable if this is the established and preferred contraception for the subject. * Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy. Note: Abstinence is acceptable if this is the established and preferred contraception for the subject. Exclusion Criteria: * Ann Arbor Stage III or IV disease at diagnosis or at relapse/refractory disease confirmation. * Bulky disease (\>10cm) at diagnosis or at relapse/refractory disease confirmation. * Active B symptoms. * Received \>1 line of therapy for Hodgkin lymphoma * Relapsed/refractory disease within a prior radiation field. * Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent. * Diagnosis of immunosuppression or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor. * Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy. * Has active autoimmune disease that has required systemic treatment in past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment * Has history of (non-infectious) pneumonitis that required steroids, evidence of interstitial lung disease or active, non infectious pneumonitis * Has an active infection requiring intravenous systemic therapy. * Has a known Human Immunodeficiency Virus (HIV), Hepatitis B (HBV), or Hepatitis C (HCV) infection * Has received a live vaccine or live attenuated vaccine within 30 days prior to first dose of study drug. Administration of killed vaccines is allowed * Any other medical condition or laboratory evaluation that, in the treating physician's or principal investigator's opinion, makes the patient unsuitable to participate in this clinical trial * Has had a prior monoclonal antibody within 4 weeks prior to study Day 1 or who has not recovered (i.e. ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier. * Has had treatment a prior monoclonal antibody targeting PD-1, PD-L1, PD-L2, or CTLA-4. * Has a pre-treatment TTE showing a calculated left ventricular ejection fraction of less than 50% * Has a pre-treatment PFT showing an DLCO adjusted for hemoglobin of less than 60% * Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Classical Hodgkin lymphoma are added.
Genom att skicka in godkänner du våra Användarvillkor
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
-
Abramson Cancer Center at University of Pennsylvania (Data Collection Only)
Philadelphia, Pennsylvania, 19104-4283, United States
-
Memorial Sloan Kettering Bergen
Montvale, New Jersey, 07645, United States
-
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
-
Memorial Sloan Kettering Commack
Commack, New York, 11725, United States
-
Memorial Sloan Kettering Monmouth
Middletown, New Jersey, 07748, United States
-
Memorial Sloan Kettering Nassau
Uniondale, New York, 11553, United States
-
Memorial Sloan Kettering Westchester
Harrison, New York, 10604, United States
-
Memorial Sloan Kettering at Basking Ridge
Basking Ridge, New Jersey, 07920, United States
-
University of Miami
Miami, Florida, 33136, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Double-Drug attack on Hard-to-Treat lymphomas
- PET scans guide Nivolumab-Chemo combo in relapsed hodgkin lymphoma
- Patient's own t cells engineered to hunt lymphoma in early trial
- Can early PET scans guide a gentler, more effective attack on hodgkin lymphoma?
- Can a calming drug make cord blood transplants safer?
- Can a new pill boost Immunotherapy's power against advanced tumors?