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NCT05675410 · National Cancer Institute (NCI)

A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab

What this study is about

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates.

View original scientific description

This phase III trial compares the effect of adding immunotherapy (brentuximab vedotin and nivolumab) to standard treatment (chemotherapy with or without radiation) to the standard treatment alone in improving survival in patients with stage I and II classical Hodgkin lymphoma. Brentuximab vedotin is in a class of medications called antibody-drug conjugates. It is made of a monoclonal antibody called brentuximab that is linked to a cytotoxic agent called vedotin.

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

BIOLOGICAL

Bleomycin Sulfate

Given IV

DRUG

Brentuximab Vedotin

Given IV

PROCEDURE

Computed Tomography

Undergo CT and/or PET-CT

DRUG

Cyclophosphamide

Given IV

DRUG

Dacarbazine

Given IV

DRUG

Doxorubicin Hydrochloride

Given IV

DRUG

Etoposide

Given IV

DRUG

Etoposide Phosphate

Given IV

OTHER

Fludeoxyglucose F-18

Undergo FDG-PET

RADIATION

Involved-site Radiation Therapy

Undergo ISRT

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI and/or PET-MRI

BIOLOGICAL

Nivolumab

Given IV

PROCEDURE

Positron Emission Tomography

Undergo FDG-PET, PET, PET-CT, and/or PET-MRI

DRUG

Prednisolone

Given PO

DRUG

Prednisone

Given PO

DRUG

Procarbazine Hydrochloride

Given PO

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Vinblastine Sulfate

Given IV

DRUG

Vincristine Sulfate

Given IV

Primary outcome measures

Progression-free survival (PFS) in rapid early responder (RER) patients

Time frame: From the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 124 events, whichever comes first

Will compare the PFS of RER patients randomized to immunotherapy (IO) therapy (brentuximab vedotin-nivolumab) against those randomized to standard therapy. PFS curves will be estimated separately by arm using Kaplan Meier methodology, and the test will be a 1-sided log-rank test between the (pooled) IO and standard arms, stratified according to the stratification factors at randomization and including all eligible and evaluable randomized patients.

PFS in slow-early responder (SER) patients

Time frame: From the time of randomization to the earliest time of disease relapse, progression, or death due to any cause, assessed up to 3 years after the randomization of the last patient or when reaching 71 events, whichever comes first

Will compare PFS among SER patients randomized to IO therapy and involved-site radiation therapy against arms containing standard therapy. PFS curves will be estimated separately by arm using Kaplan Meier methodology, and the test will be a 1-sided log-rank test between the (pooled) IO and standard arms, stratified according to the stratification factors at randomization and including all eligible and evaluable randomized patients.

Who can participate

This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.

Inclusion criteria

  • Patients must be 5 to 60 years of age at the time of enrollment
  • Patients with newly diagnosed untreated histologically confirmed classic Hodgkin lymphoma (cHL) (nodular sclerosis, mixed cellularity, lymphocyte-rich, or lymphocyte-depleted, or not otherwise specified \[NOS\]) with stage I or II disease
  • Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)
  • Patients must have a whole body or limited whole body PET scan performed within 42 days prior to enrollment. PET-CT is strongly preferred. PET-MRI allowed if intravenous contrast enhanced CT is also obtained
  • Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for assessment of bulky mediastinal disease.
  • Note: Pediatric patients who have received both a CT chest and upright PA CXR may meet the definition of bulk through either modality.
  • Patients \>= 18 years must have a performance status corresponding to Zubrod scores of 0, 1 or 2
  • Patients =\< 17 years of age must have a Lansky performance score of \>= 50
  • Pediatric patients (age 5-17 years): A serum creatinine based on age/sex as follows (within 28 days prior to enrollment):
  • 2 to \< 6 years (age): 0.8 mg/dL (male), 0.8 mg/dL (female)
  • 6 to \< 10 years (age): 1 mg/dL (male), 1 mg/dL (female)
  • 10 to \< 13 years (age): 1.2 mg/dL (male), 1.2 mg/dL (female)
  • 13 to \< 16 years (age): 1.5 mg/dL (male), 1.4 mg/dL (female)
  • \>= 16 years (age): 1.7 mg/dL (male), 1.4 mg/dL (female) OR a 24 hour urine creatinine clearance \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment) OR a glomerular filtration rate (GFR) \>= 50 mL/min/1.73 m\^2 (within 28 days prior to enrollment). GFR must be performed using direct measurement with a nuclear blood sampling method OR direct small molecule clearance method (iothalamate or other molecule per institutional standard)
  • Note: Estimated GFR (eGFR) from serum or plasma creatinine, cystatin C or other estimates are not acceptable for determining eligibility
  • For adult patients (age 18 years or older) (within 28 days prior to enrollment): Creatinine clearance \>= 30 mL/min, as estimated by the Cockcroft and Gault formula or a 24-hour urine collection. The creatinine value used in the calculation must have been obtained within 28 days prior to registration. Estimated creatinine clearance is based on actual body weight
  • Total bilirubin =\< 2 x upper limit of normal (ULN) (within 28 days prior to enrollment)
  • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
  • Aspartate aminotransferase (AST) =\< 3 x ULN (within 28 days prior to enrollment)
  • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
  • Alanine aminotransferase (ALT) =\< 3 x ULN (within 28 days prior to enrollment)
  • Unless due to Gilbert's disease, lymphomatous involvement of liver or vanishing bile duct syndrome
  • Shortening fraction of \>= 27% by echocardiogram (ECHO), multigated acquisition scan (MUGA), or functional cardiac imaging scan (within 28 days prior to enrollment) or ejection fraction of \>= 50% by radionuclide angiogram, ECHO, MUGA, or cardiac imaging scan (within 28 days prior to enrollment)
  • Diffusion capacity of the lung for carbon monoxide (DLCO) \>= 50% of predicted value as corrected for hemoglobin by pulmonary function test (PFT) (within 28 days prior to enrollment). If unable to obtain PFTs, the criterion is: a pulse oximetry reading of \> 92% on room air
  • Known human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load

Exclusion criteria

  • Patients with nodular lymphocyte predominant Hodgkin lymphoma
  • Patients with a history of active interstitial pneumonitis or interstitial lung disease
  • Patients with a diagnosis of inherited or acquired immunodeficiency that is poorly controlled or requiring active medications, such as primary immunodeficiency syndromes or organ transplant recipients
  • Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions, cardiac arrhythmias, angina pectoris, and gastrointestinal disorders affecting swallowing and/or absorption of pills
  • Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients \>= 18 years or \> 0.5 mg/kg \[up to 10 mg/day\] for patients \< 18 years) or other immunosuppressive medications within 14 days prior to enrollment
  • Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form of systemic treatment. Inhaled or topical steroids, and adrenal replacement doses (=\< 10 mg daily for patients \>= 18 years or =\< 0.5 mg/kg \[up to 10 mg/day\] predniSONE equivalents) are permitted in the absence of active autoimmune disease
  • Note: Steroid use for the control of Hodgkin lymphoma symptoms is allowable, but must be discontinued by cycle 1, day 1
  • Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.
  • Patients with peripheral neuropathy \> grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
  • Patients with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen
  • Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL
  • Prior solid organ transplant
  • Prior allogeneic stem cell transplantation
  • Live vaccine within 30 days prior to planned day 1 of protocol therapy (e.g., measles, mumps, rubella, varicella, yellow fever, rabies, bacillus Calmette Guerin \[BCG\], oral polio vaccine, and oral typhoid). Administration of messenger ribonucleic acid (mRNA) vaccines are permitted
  • Female patients who are pregnant since fetal toxicities and teratogenic effects have been noted for several of the study drugs. A pregnancy test within 28 days prior to enrollment is required for female patients of childbearing potential
  • Lactating females who plan to breastfeed their infants starting with the first dose of study therapy and for at least 6 months after the last treatment
  • Sexually active patients of reproductive potential who have not agreed to use a highly effective contraceptive method for the duration of their study drug therapy. Following therapy, patients will be advised to use contraception as per institutional practice or as listed below for investigational agents, whichever is longer
  • Men and women of childbearing potential (WOCBP) must use effective contraception during the study and for 2 months for WOCBP and 4 months for men, after last dose of brentuximab vedotin
  • WOCBP must continue contraception for a period of at least 5 months after the last dose of nivolumab
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Where

  • Birmingham, Alabama
  • Mobile, Alabama
  • Anchorage, Alaska
  • Goodyear, Arizona
  • Mesa, Arizona
  • Phoenix, Arizona
  • Little Rock, Arkansas
  • Carmichael, California
  • Corona, California
  • Costa Mesa, California
  • Downey, California
  • Duarte, California

And 288 more locations — see the full list below.

Related conditions & keywords

Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8

Frequently asked questions

What is a clinical trial?

A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.

Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.

Will I be compensated?

Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.

Will I receive a placebo instead of treatment?

When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.

Can I leave a trial if I change my mind?

Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.

How long does a clinical trial last?

Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.

Data: ClinicalTrials.gov · synced Oct 16, 2026 · Source of record for eligibility and locations

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1 of 1875 participants interested
0% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

Preparing your pre-screening questions…

Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Birmingham

Alabama

Location available
RECRUITING

Mobile

Alabama

Location available
RECRUITING

Anchorage

Alaska

Location available
RECRUITING

Goodyear

Arizona

Location available
RECRUITING

Mesa

Arizona

Location available
View Mesa location page
RECRUITING

Phoenix

Arizona

Location available
RECRUITING

Phoenix

Arizona

Location available
RECRUITING

Little Rock

Arkansas

Location available
RECRUITING

Carmichael

California

Location available

And 393 more locations available.

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Hodgkin Lymphoma Treatment in Birmingham?

Join others in Alabama exploring innovative treatment options through clinical research

Hodgkin Lymphoma Treatment Options in Birmingham, Alabama

If you're searching for Hodgkin Lymphoma treatment in Birmingham, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Birmingham, Mobile, Anchorage and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Hodgkin Lymphoma. All study-related care is provided at no cost to participants.

Local Sites
3 locations in Alabama
Now Enrolling
Up to 1875 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Hodgkin Lymphoma?

Potential Benefits

  • ✓Access to new treatment approaches before public availability
  • ✓Close monitoring by experienced medical professionals
  • ✓Study-related care provided at no cost
  • ✓Contribute to medical research for Hodgkin Lymphoma

What to Expect

  • →Initial screening to determine eligibility
  • →Regular check-ups and monitoring visits
  • →Possible compensation for time and travel
  • →You can withdraw at any time

Frequently Asked Questions About This Hodgkin Lymphoma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT05675410. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.