PHASE3RECRUITING

Comparing 8 approaches for lugano classification limited stage Hodgkin lymphoma AJCC v8

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

A Randomized Phase 3 Interim Response Adapted Trial Comparing Standard Therapy With Immuno-oncology Therapy for Children and Adults With Newly Diagnosed Stage I and II Classic Hodgkin Lymphoma

Condition: Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8Sponsor: National Cancer Institute (NCI)Target enrollment: 1875

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

Canadian Sites (14)

CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)

Québec, Canada

RECRUITING

Alberta Children's Hospital

Calgary, Alberta, Canada

RECRUITING

University of Alberta Hospital

Edmonton, Alberta, Canada

RECRUITING

British Columbia Children's Hospital

Vancouver, British Columbia, Canada

RECRUITING

CancerCare Manitoba

Winnipeg, Manitoba, Canada

RECRUITING

IWK Health Centre

Halifax, Nova Scotia, Canada

RECRUITING

McMaster Children's Hospital at Hamilton Health Sciences

Hamilton, Ontario, Canada

RECRUITING

Children's Hospital

London, Ontario, Canada

RECRUITING

Children's Hospital of Eastern Ontario

Ottawa, Ontario, Canada

RECRUITING

Hospital for Sick Children

Toronto, Ontario, Canada

RECRUITING

The Montreal Children's Hospital of the MUHC

Montreal, Quebec, Canada

RECRUITING

Centre Hospitalier Universitaire Sainte-Justine

Montreal, Quebec, Canada

RECRUITING

Centre Hospitalier Universitaire de Sherbrooke-Fleurimont

Sherbrooke, Quebec, Canada

RECRUITING

Jim Pattison Children's Hospital

Saskatoon, Saskatchewan, Canada

SUSPENDED

See who this study is looking for47 criteria

The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.

Inclusion

+Patients must be 5 to 60 years of age at the time of enrollment
+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.
+Pediatric patients (age 5-17 years): A serum creatinine based on age/sex as follows (within 28 days prior to enrollment):
+Patients must have bidimensionally measurable disease (at least one lesion with longest diameter \>= 1.5 cm)
+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
+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 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
+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
+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

Exclusion

−Short term use of corticosteroids for premedication or treatment of an allergy or hypersensitivity is considered an acceptable use of corticosteroids.
−All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
−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
−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
−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
−All patients and/or their parents or legal guardians must sign a written informed consent
−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
−Administration of prior chemotherapy, radiation, or antibody-based treatment for cHL

5 concepts to explore on this page · up to 1,300 pointsTap any term to learn what it means.

In plain language

Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.

Learning

What this study is

This study is testing a treatment for a condition.

Phase 3 — a large study comparing this against the current standard, usually across many hospitals.

What is being given or done in this study: Biospecimen Collection, Bleomycin Sulfate, Brentuximab Vedotin, Computed Tomography, and 16 more.

From the trial registry

Built from these fields:

designModule.designInfo.primaryPurpose
designModule.phases
armsInterventionsModule.interventions[].name

How the study is run

Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.

This study is open-label: everyone knows which treatment is being given, including you and the study team.

From the trial registry

Built from these fields:

designModule.designInfo.allocation
designModule.designInfo.maskingInfo.masking

Is there a placebo?

This study does not list a placebo group.

One group receives an existing treatment, so the two can be compared.

There are 8 groups in this study.

From the trial registry

Built from this field:

armsInterventionsModule.armGroups[].type

Who the study is looking for

The study lists an age range of 5 years to 60 years.

The study is open to people of any sex.

The study does not accept healthy volunteers.

These are the criteria the study lists. Only the trial site can decide whether someone can take part.

From the trial registry

Built from these fields:

eligibilityModule.minimumAge
eligibilityModule.maximumAge
eligibilityModule.sex
eligibilityModule.healthyVolunteers

How big and how long

The study aims to enrol about 1,875 people.

The study is currently expected to finish around April 2031.

The main measurement is taken over: 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.

From the trial registry

Built from these fields:

designModule.enrollmentInfo.count
statusModule.completionDateStruct.date
outcomesModule.primaryOutcomes[].timeFrame

What the study measures

Progression-free survival (PFS) in rapid early responder (RER) patients — measured over 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.

PFS in slow-early responder (SER) patients — measured over 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.

From the trial registry

Built from these fields:

outcomesModule.primaryOutcomes[].measure
outcomesModule.primaryOutcomes[].timeFrame

Source: NCT05675410 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.

Not medical advice. What do these terms mean?