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Résztvevőt keres itt: Kanada3. fázis

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

A legfontosabb adatok

Ki végzi
National Cancer Institute (NCI)
Hol
Calgary, Edmonton, Halifax, Hamilton, London, Montreal, Ottawa, Québec, Saskatoon, Sherbrooke, Toronto, Vancouver és Winnipeg (Kanada)Mind a 14 helyszín megnézéseMég 2 másik országban, 405 helyszínen
Azonosító
Állapot
Toboroz
Fázis
3. fázis
Résztvevők
1875 fő, tervezett
Kezdés
2023. máj. 11.
Várható befejezés
2031. ápr. 28.
A vizsgálat típusa
Beavatkozással járó, 8 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
A vizsgált kezelések
  • Biospecimen Collection
  • Bleomycin Sulfate
  • Brentuximab Vedotin
  • Computed Tomography
  • Cyclophosphamide
  • Dacarbazine
  • Doxorubicin Hydrochloride
  • Etoposide
  • Etoposide Phosphate
  • Fludeoxyglucose F-18
  • Involved-site Radiation Therapy
  • Magnetic Resonance Imaging
  • Nivolumab
  • Positron Emission Tomography
  • Prednisolone
  • Prednisone
  • Procarbazine Hydrochloride
  • Questionnaire Administration
  • Vinblastine Sulfate
  • Vincristine Sulfate
A regiszteradat frissítve
2026. november 12.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat újonnan diagnosztizált, még nem kezelt, I. vagy II. stádiumú klasszikus Hodgkin-limfómás gyermekeket és felnőtteket keres. A hagyományos kezelést hasonlítja össze azzal, amikor ehhez brentuximab vedotint és nivolumabot is adnak.

Életkor
5 és 60 év között
Nem
Nemtől függetlenül részt vehet.
A betegség stádiuma
Újonnan diagnosztizált, szövettanilag igazolt klasszikus Hodgkin-limfóma, I. vagy II. stádium, legalább egy 1,5 cm (0,6 in) vagy nagyobb átmérőjű elváltozással.
Korábbi kezelés
A klasszikus Hodgkin-limfómára korábban nem kaphatott kemoterápiát, sugárkezelést vagy antitest-alapú kezelést.

A részvétel fő kizáró okai

  • Nodularis lymphocyta-predominans Hodgkin-limfóma
  • Korábbi aktív interstitialis tüdőgyulladás vagy interstitialis tüdőbetegség
  • Korábbi szervátültetés vagy allogén őssejt-átültetés
  • Terhes nők, és azok a szoptató nők, akik tovább akarnak szoptatni
  • Az 1. fokozatnál súlyosabb perifériás idegbántalom, vagy Charcot-Marie-Tooth-szindróma

A regiszter feltételei, szó szerint

Mind a 32 feltétel megnézéseKevesebb

Ki vehet részt

  • 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

Ki nem vehet részt

  • 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 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
  • 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 peripheral neuropathy > grade 1 at the time of enrollment or patients with known Charcot-Marie-Tooth syndrome
  • 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
  • All patients and/or their parents or legal guardians must sign a written informed consent

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 5 és 60 év között vagy?

Helyszínek itt: Kanada

Még 2 másik országban, 405 helyszínen

  • Alberta Children's HospitalCalgary, KanadaContact: Victor A. Lewis (principal investigator)Résztvevőt keres
  • University of Alberta HospitalEdmonton, KanadaContact: Sarah J. McKillop (principal investigator)Résztvevőt keres
  • IWK Health CentreHalifax, KanadaContact: Chelsea Ash (principal investigator)Résztvevőt keres
  • McMaster Children's Hospital at Hamilton Health SciencesHamilton, KanadaContact: Uma H. Athale (principal investigator)Résztvevőt keres
  • Children's HospitalLondon, KanadaContact: Shayna M. Zelcer (principal investigator)Résztvevőt keres
  • Centre Hospitalier Universitaire Sainte-JustineMontreal, KanadaContact: Monia Marzouki (principal investigator)Résztvevőt keres
  • The Montreal Children's Hospital of the MUHCMontreal, KanadaContact: Stephanie Mourad (principal investigator)Résztvevőt keres
  • Children'S Hospital Of Eastern OntarioOttawa, KanadaContact: Donna L. Johnston (principal investigator)Résztvevőt keres
  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)Québec, KanadaContact: Bruno Michon (principal investigator)Résztvevőt keres
  • Jim Pattison Children's HospitalSaskatoon, KanadaContact: Kathleen Felton (principal investigator)Résztvevőt keres
  • Centre Hospitalier Universitaire de Sherbrooke-FleurimontSherbrooke, KanadaContact: Stephanie Vairy (principal investigator)Résztvevőt keres
  • Hospital for Sick ChildrenToronto, KanadaContact: Angela S. Punnett (principal investigator)Résztvevőt keres
  • British Columbia Children's HospitalVancouver, KanadaContact: Rebecca J. Deyell (principal investigator)Résztvevőt keres
  • CancerCare ManitobaWinnipeg, KanadaContact: Stephanie M. Villeneuve (principal investigator)Résztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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. Brentuximab attaches to CD30 positive lymphoma cells in a targeted way and delivers vedotin to kill them. A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Chemotherapy drugs such as doxorubicin hydrochloride, bleomycin sulfate, vinblastine sulfate, dacarbazine, and procarbazine hydrochloride work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Cyclophosphamide is in a class of medications called alkylating agents. It works by damaging the cell's deoxyribonucleic acid (DNA) and may kill cancer cells. It may also lower the body's immune response. Etoposide is in a class of medications known as podophyllotoxin derivatives. It blocks a certain enzyme needed for cell division and DNA repair and may kill cancer cells. Vincristine is in a class of medications called vinca alkaloids. It works by stopping cancer cells from growing and dividing and may kill them. Prednisone is in a class of medications called corticosteroids. It is used to reduce inflammation and lower the body's immune response to help lessen the side effects of chemotherapy drugs. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Adding immunotherapy to the standard treatment of chemotherapy with or without radiation may increase survival and/or fewer short-term or long-term side effects in patients with classical Hodgkin lymphoma compared to the standard treatment alone.

A vizsgálat 8 csoportja

  • Arm A (ABVD)Már használt kezelés, összehasonlításként

    Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive ABVD IV for an additional 2 cycles on study. Each cycle lasts 28 days and ABVD is administered on days 1 and 15 of each cycle in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.

    Kezelés: Biospecimen Collection, Bleomycin Sulfate, Computed Tomography, Dacarbazine, Doxorubicin Hydrochloride, Fludeoxyglucose F-18, Magnetic Resonance Imaging, Positron Emission Tomography, Questionnaire Administration és Vinblastine Sulfate

  • Arm B (ABVD, brentuximab vedotin, nivolumab)A vizsgált kezelés

    Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive brentuximab vedotin IV over 30 minutes and nivolumab IV over 30 minutes once during each treatment cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.

    Kezelés: Biospecimen Collection, Bleomycin Sulfate, Brentuximab Vedotin, Computed Tomography, Dacarbazine, Doxorubicin Hydrochloride, Fludeoxyglucose F-18, Magnetic Resonance Imaging, Nivolumab, Positron Emission Tomography, Questionnaire Administration és Vinblastine Sulfate

  • Arm C (ABVD, eBEACOPP or eBPDac, ISRT)A vizsgált kezelés

    See Detailed Description.

    Kezelés: Biospecimen Collection, Bleomycin Sulfate, Computed Tomography, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Etoposide Phosphate, Fludeoxyglucose F-18, Involved-site Radiation Therapy, Magnetic Resonance Imaging, Positron Emission Tomography, Prednisolone, Prednisone, Procarbazine Hydrochloride, Questionnaire Administration, Vinblastine Sulfate és Vincristine Sulfate

  • Arm D (ABVD, brentuximab vedotin, nivolumab, ISRT)A vizsgált kezelés

    Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive brentuximab vedotin IV and nivolumab IV as in arm B followed by ISRT. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.

    Kezelés: Biospecimen Collection, Bleomycin Sulfate, Brentuximab Vedotin, Computed Tomography, Dacarbazine, Doxorubicin Hydrochloride, Fludeoxyglucose F-18, Involved-site Radiation Therapy, Magnetic Resonance Imaging, Nivolumab, Positron Emission Tomography, Questionnaire Administration és Vinblastine Sulfate

  • Arm E (ABVD, AVD)A vizsgált kezelés

    Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive AVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, vinblastine IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.

    Kezelés: Biospecimen Collection, Bleomycin Sulfate, Computed Tomography, Dacarbazine, Doxorubicin Hydrochloride, Fludeoxyglucose F-18, Magnetic Resonance Imaging, Positron Emission Tomography, Questionnaire Administration és Vinblastine Sulfate

  • Arm F (ABVD, brentuximab vedotin, nivolumab)A vizsgált kezelés

    Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment as in arm B. Patients also undergo FDG-PET, PET, PET-CT, PET-MRI, CT, and/or MRI throughout the trial. Patients may also undergo blood sample collection on trial.

    Kezelés: Biospecimen Collection, Bleomycin Sulfate, Brentuximab Vedotin, Computed Tomography, Dacarbazine, Doxorubicin Hydrochloride, Fludeoxyglucose F-18, Magnetic Resonance Imaging, Nivolumab, Positron Emission Tomography, Questionnaire Administration és Vinblastine Sulfate

  • Arm G (ABVD, eBEACOPP or eBPDac, ISRT)A vizsgált kezelés

    Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment and imaging, and may undergo blood sample collection as in arm C.

    Kezelés: Biospecimen Collection, Bleomycin Sulfate, Computed Tomography, Cyclophosphamide, Dacarbazine, Doxorubicin Hydrochloride, Etoposide, Etoposide Phosphate, Fludeoxyglucose F-18, Involved-site Radiation Therapy, Magnetic Resonance Imaging, Positron Emission Tomography, Prednisolone, Prednisone, Procarbazine Hydrochloride, Questionnaire Administration, Vinblastine Sulfate és Vincristine Sulfate

  • Arm H (ABVD, brentuximab vedotin, nivolumab, ISRT)A vizsgált kezelés

    Patients are stratified by risk status (favorable versus unfavorable) and then all patients receive the ABVD regimen (doxorubicin hydrochloride IV over 3-15 minutes, bleomycin sulfate IV over at least 10 minutes, vinblastine sulfate IV, and dacarbazine IV over 15-60 minutes) on days 1 and 15 of each treatment cycle. Cycles repeat every 28 days for up to 2 cycles in the absence of disease progression or unacceptable toxicity. Patients then undergo FDG-PET/CT or MRI and are identified as RER or SER. Patients then receive treatment and imaging, and may undergo blood sample collection as in arm D.

    Kezelés: Biospecimen Collection, Bleomycin Sulfate, Brentuximab Vedotin, Computed Tomography, Dacarbazine, Doxorubicin Hydrochloride, Fludeoxyglucose F-18, Involved-site Radiation Therapy, Magnetic Resonance Imaging, Nivolumab, Positron Emission Tomography, Questionnaire Administration és Vinblastine Sulfate

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
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
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
Illeszkedési kérdések
Forrás: NCT05675410: ki vehet részt
A regiszteradat frissítve
2026. november 12.