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Compares treatment options 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
ClinicalTrials.gov ID: NCT05675410
What this study is testing
What is Bleomycin Sulfate?
Bleomycin Sulfate is an investigational medicine, given as an once-daily infusion into a vein, being studied as a potential treatment for lugano classification limited stage hodgkin lymphoma ajcc v8.
Also referred to as Blanoxan, BleMomycine.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 60
You may be able to join if
- 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...
- 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...
- Pediatric patients (age 5-17 years) with known or suspected mediastinal disease must have an upright posteroanterior (PA) chest X-ray (CXR) for...
You likely can't join if
- 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...
- Patients with any known uncontrolled intercurrent illness that would jeopardize the patient's safety such as infection, autoimmune conditions...
- Patients with a condition requiring systemic treatment with either corticosteroids (defined as equivalent to \> 10 mg daily predniSONE for patients...
- Note: Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid for adrenal or pituitary insufficiency is not considered a form...
See the full eligibility criteria
Who can join
- 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...
- 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 =\ = 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...
- 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...
- 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...
- 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...
- 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...
What rules you out
- 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...
- 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...
- 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...
- 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 how well it works 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)...
- 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...
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Birmingham, Alabama, United States
- Mobile, Alabama, United States
- Anchorage, Alaska, United States
- Goodyear, Arizona, United States
- Mesa, Arizona, United States
- Phoenix, Arizona, United States
- Little Rock, Arkansas, United States
- Carmichael, California, United States
- Corona, California, United States
- Costa Mesa, California, United States
- Downey, California, United States
- Duarte, California, United States
- Dublin, California, United States
- Elk Grove, California, United States
- Fremont, California, United States
- Fresno, California, United States
- Huntington Beach, California, United States
- Irvine, California, United States
- Lancaster, California, United States
- Loma Linda, California, United States
+ 289 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 5 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Birmingham, Alabama, United States; Mobile, Alabama, United States; Anchorage, Alaska, United States; Goodyear, Arizona, United States; Mesa, Arizona, United States; Phoenix, Arizona, United States and 303 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.