[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"recurrent-classic-hodgkin-lymphoma\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:recurrent-classic-hodgkin-lymphoma":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":4},"100636933","phase-2-evaluating-the-addition-of-maintenance-immunotherapy-compared-to-the-usual-treatment-of-chemotherapy-and-autologous-stem-cell-transplant-alone-for-high-risk-patients-with-relapsed-or-refractory-hodgkin-lymphoma-100636933",false,"NCT07572123","Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem Cell Transplant Alone for High-risk Patients With Relapsed or Refractory Hodgkin Lymphoma","A Two Cohort Randomized Study for Patients With High Risk (Phase II) and Standard Risk (Phase III) Classical Hodgkin Lymphoma in First Relapse","Inclusion Criteria:\n\n* STEP 0 REGISTRATION: Patient must have biopsy confirmed relapsed classical Hodgkin lymphoma\n* STEP 0 REGISTRATION: Patient must be 5-75 years of age\n* STEP 0 REGISTRATION: Patient must have relapsed\u002Frefractory classical Hodgkin lymphoma (R\u002FR cHL) after first line of chemotherapy\n* STEP 0 REGISTRATION: Patients \\> 17 years of age must have an Eastern Cooperative Oncology Group (ECOG) performance status 0-2 and patients ≤ 17 years of age must have a Lansky performance status 50-100\n* STEP 0 REGISTRATION: Patient must have had a PET CT or magnetic resonance imaging (MRI) (PET1) confirming relapse. The PET1 must have been completed prior to starting any salvage therapy and must be obtained within 56 days prior to Step 0 registration\n\n  * NOTE: If patient received one cycle of salvage prior to study enrollment, PET1 confirming relapse must have been completed prior to the initiation of any salvage therapy\n* STEP 0 REGISTRATION: Patient must be considered standard- or high-risk at the time of initial relapse. If a patient meets one the following criteria below, they are considered high risk:\n\n  * Primary refractory disease to frontline therapy\n  * Relapse in \\\u003C 3 months after completion of frontline non-checkpoint inhibitor containing therapy\n  * Relapse in \\\u003C 6 months after completion of frontline checkpoint inhibitor containing therapy\n  * \\> 4 disease sites at relapse (as defined by the German Hodgkin Study Groups \\[GHSG\\] Criteria)\n  * Prior radiation that would result in overlapping fields that would exceed the RT dose to critical organs. For additional questions, contact the radiation oncology study co-chairs\n  * Patients with bone marrow involvement\n\n    * Patients who do not meet the criteria above are considered standard risk\n* STEP 0 REGISTRATION: Patient must be considered eligible for high dose chemotherapy and autologous hematopoietic cell transplant\n* STEP 0 REGISTRATION: Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 0 registration to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria:\n\n    * Has achieved menarche\n    * Has not undergone a hysterectomy or bilateral oophorectomy\n    * Has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* STEP 0 REGISTRATION: Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study\n* STEP 0 REGISTRATION: Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and\u002For family member available will also be considered eligible\n* STEP 0 REGISTRATION: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3 (≤ 14 days prior to Step 0 registration)\n* STEP 0 REGISTRATION: Platelets ≥ 100,000\u002Fmm\\^3 (≤ 14 days prior to Step 0 registration)\n* STEP 0 REGISTRATION: Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (≤ 14 days prior to Step 0 registration)\n* STEP 0 REGISTRATION: Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \\[SGOT\\]) and alanine aminotransferase (ALT) (serum glutamic pyruvic transaminase \\[SGPT\\]) ≤ 3.0 x institutional ULN (≤ 14 days prior to Step 0 registration)\n* STEP 0 REGISTRATION: Estimated glomerular filtration rate (GFR) (eGRF) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 for patients \\> 17 years of age (≤ 14 days prior to Step 0 registration)\n* STEP 0 REGISTRATION: Pediatric patients (\\\u003C 17 years old) must have one of the following: (≤ 14 days prior to Step 0 registration)\n\n  * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m2 using the Bedside Schwartz formula (2009)\n  * 24 hour urine creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m\\^2\n  * GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2\n\n    * Note: 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).\n  * NOTE: Estimated GFR (eGFR) from cystatin C or other estimates not listed above are not acceptable for determining eligibility\n* STEP 0 REGISTRATION: Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 0 registration are eligible for this trial\n* STEP 0 REGISTRATION: For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated\n* STEP 0 REGISTRATION: 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\n* STEP 0 REGISTRATION: Patient must not have any current or prior history of central nervous system (CNS) lymphoma\n* STEP 0 REGISTRATION: Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial\n* STEP 0 REGISTRATION: Patients must not have grade 2 or greater peripheral motor sensory neuropathy\n* STEP 0 REGISTRATION: Patient must not have a history of (non-infectious) pneumonitis\u002Finterstitial lung disease that required steroids or have current pneumonitis\u002Finterstitial lung disease\n* STEP 0 REGISTRATION: Patient must not have the following symptomatic autoimmune disorders: rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythematosus, Sjögren's syndrome, or autoimmune vasculitis (e.g., Wegener's granulomatosis), or conditions of immunosuppression that require current ongoing treatment with systemic corticosteroids (or other systemic immunosuppressants), including oral steroids (i.e., prednisone, dexamethasone). Patients who discontinue use of these classes of medication for at least 2 weeks prior to randomization eligible if, in the judgment of the treating physician investigator, the patient is not likely to require resumption of treatment with these classes of drugs during the study\n\n  * Replacement doses of steroids for patients with adrenal insufficiency are allowed\n  * Additionally, patients must not have an autoimmune disease that is felt by the treating physician to have the potential to be exacerbated by checkpoint inhibition\n* STEP 1 RANDOMIZATION: Patient must have undergone 2-4 cycles of salvage treatment as part of Step 0 of this protocol\n* STEP 1 RANDOMIZATION: Patients must be considered eligible for high dose chemotherapy and autologous hematopoietic cell transplant\n* STEP 1 RANDOMIZATION: Patient must have had a PET CT (PET2) following 2 cycles of on study salvage therapy and demonstrate complete metabolic response (CMR) or partial metabolic response (PMR). Patients with stable disease\u002Fno metabolic response (SD\u002FNMR) or progressive metabolic disease (PMD) are ineligible to proceed to Step 1 randomization\n* STEP 1 RANDOMIZATION: Absolute neutrophil count (ANC) ≥ 1,000\u002Fmm\\^3 (≤ 14 days prior to Step 1 randomization)\n* STEP 1 RANDOMIZATION: Platelets ≥ 75,000\u002Fmm\\^3 (≤ 14 days prior to Step 1 randomization)\n* STEP 1 RANDOMIZATION: Total bilirubin ≤ 2 x institutional upper limit of control (ULN) (≤ 14 days prior to Step 1 randomization)\n* STEP 1 RANDOMIZATION: AST(SGOT) and ALT(SGPT) ≤ 3.0 x institutional ULN (≤ 14 days prior to Step 1 randomization)\n* STEP 1 RANDOMIZATION: Pediatric patients (\\\u003C 17 years old) must have one of the following: (≤ 14 days prior to Step 1 randomization)\n\n  * Estimated GFR (eGFR) ≥ 50 mL\u002Fmin\u002F1.73 m\\^2 using the Bedside Schwartz formula (2009)\n  * 24 hour urine creatinine clearance ≥ 50 mL\u002Fmin\u002F1.73 m\\^2\n  * GFR ≥ 50 mL\u002Fmin\u002F1.73 m\\^2. 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)\n  * NOTE: Estimated GFR (eGFR) from cystatin C or other estimates not listed above are not acceptable for determining eligibility\n* STEP 1 RANDOMIZATION: Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used\n\n  * All patients of childbearing potential must have a blood test or urine study within 14 days prior to Step 1 randomization to rule out pregnancy\n  * A patient of childbearing potential is defined as anyone, regardless of whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months)\n* STEP 1 RANDOMIZATION: Patient must not expect to conceive or father children by using accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. Patients of childbearing potential must continue to use contraceptive measures for 5 months after the last dose of nivolumab and for 4 months after the last dose of pembrolizumab, as well as not breastfeed during these same timeframes","ALL","5 Years","75 Years",{"count":20,"type":21},374,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE2","PHASE3","This phase II trial compares the impact of brentuximab vedotin and nivolumab after radiation to standard of care high dose chemotherapy (HDT)-autologous stem cell transplant (ASCT) in standard-risk patients with classic Hodgkin lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). In addition, the phase III trial will compare the effect of pembrolizumab after HDT-ASCT to standard of care HDT-ASCT alone in high-risk patients with relapsed or refractory classic 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. Immunotherapy with monoclonal antibodies, such as nivolumab and pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. An ASCT is a procedure in which blood-forming stem cells (cells from which all blood cells develop) are removed, stored, and later given back to the same person. Giving HDT before an ASCT helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Radiation therapy (RT) uses high energy x-rays, particles, or radioactive seeds to kill cancer cells and shrink tumors. Giving brentuximab vedotin and nivolumab after radiation may be safe, tolerable and more effective than standard of care HDT-ASCT in treating patients with standard risk relapsed or refractory classic Hodgkin lymphoma. In addition, giving pembrolizumab after standard of care HDT-ASCT may be safe and tolerable and more effective than HDT-ASCT alone in treating high-risk patients with relapsed or refractory classic Hodgkin lymphoma.",[28,29],"Recurrent Classic Hodgkin Lymphoma","Refractory Classic Hodgkin Lymphoma","NOT_YET_RECRUITING","2026-05-12",{"date":33,"type":34},"2026-05-13","ACTUAL",{"date":36,"type":21},"2026-12-04",{"date":38,"type":21},"2029-03-31",{"name":40,"class":41},"National Cancer Institute (NCI)","NIH",{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":4,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":53,"conditions":54,"keywords":4,"overallStatus":55,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":5},"100442260","phase-2-brentuximab-vedotin-and-nivolumab-for-the-treatment-of-relapsedrefractory-classic-hodgkin-lymphoma-previously-treated-with-brentuximab-vedotin-or-checkpoint-inhibitors-100442260","NCT05039073","Brentuximab Vedotin and Nivolumab for the Treatment of Relapsed\u002FRefractory Classic Hodgkin Lymphoma Previously Treated With Brentuximab Vedotin or Checkpoint Inhibitors","A Phase 2 Study of Brentuximab Vedotin Plus Nivolumab in Patients With Relapsed\u002FRefractory Hodgkin Lymphoma Previously Treated With Brentuximab or Checkpoint Inhibitors","Inclusion Criteria:\n\n* Histologically confirmed classical Hodgkin lymphoma\n* Patients must be 12 years of age or older\n* Patients must have received at least 1-2 prior multi-agent chemotherapy or immunotherapy regimens will be divided into two cohorts based on the following clinical scenarios:\n\n  * Patients enrolled to cohort A must have received only ONE prior brentuximab-containing regimen with NO prior checkpoint inhibitors. Patients enrolled to cohort A must have received brentuximab as part of their first-line treatment regimen.\n  * Patients enrolled to cohort B must have received only ONE prior immune checkpoint inhibitor- (i.e. nivolumab or pembrolizumab) containing regimen and NO prior brentuximab. Patients in cohort B may have received an immune checkpoint inhibitor during either their first- or second-line treatment regimen.\n  * If radiation is used as part of the planned front-line treatment regimen (i.e., brentuximab vedotin-doxorubicin-vinblastine-dacarbazine \\[BV-AVD\\] + radiation therapy \\[RT\\] for bulky stage II disease), this will count as only 1 prior therapy. Additionally, radiation as consolidation after a second-line multi-agent chemotherapy regimen is permitted and will not be counted as a third regimen\n* No prior autologous or allogeneic transplant\n* Eastern Cooperative Oncology Group (ECOG) performance status =\\\u003C 2 for patients \\> 18 years old, or Lansky performance status of \\>= 50 for patients ages 12-18 years\n* Enrolling patients must have measurable disease defined as a tumor or nodal mass \\> 1.5 cm in at least one dimension\n* Resolution of all prior toxicities, including peripheral neuropathy, to a =\\\u003C grade 1\n* Absolute neutrophil count (ANC) \\>= 750, unless disease related (within 28 days of cycle 1 day 1)\n* Platelets \\>= 50,000, unless disease related (within 28 days of cycle 1 day 1)\n* Creatinine =\\\u003C upper limit of normal (ULN) (within 28 days of cycle 1 day 1)\n* Aspartate aminotransferase\u002Falanine aminotransferase (AST\u002FALT) =\\\u003C 3 x ULN (within 28 days of cycle 1 day 1)\n* Bilirubin =\\\u003C 2 mg\u002FdL (within 28 days of cycle 1 day 1)\n* Patients with human immunodeficiency virus (HIV) infection are eligible. Patients with HIV infection must meet the following criteria: No evidence of co-infection with hepatitis B or C; CD4+ count \\>= 400\u002Fmm; no evidence of resistant strains of HIV; on anti-HIV therapy with an HIV viral load \\\u003C 50 copies HIV ribonucleic acid (RNA)\u002FmL. Patients with HIV must have ongoing follow-up with an infectious disease specialist and must have been evaluated within 90 days of cycle 1 day 1.\n* Females of child-bearing potential (FCBP) must have a negative urine pregnancy test prior to starting therapy. If the test is positive, pregnancy must be ruled out\n* FCBP and men treated or enrolled on this protocol must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry for the duration of study participation, and 6 months after completion of brentuximab and\u002For nivolumab administration. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.\n\n  * A female of childbearing potential (FCBP) is a post-menarcheal woman who: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months\n* Completion of all previous therapy (including surgery, radiotherapy, chemotherapy, immunotherapy, or investigational therapy) for the treatment of cancer \\>= 2 weeks before the start of study therapy\n* Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better\n* Willingness and ability of the subject to comply with scheduled visits, drug administration plan, protocol-specified laboratory tests, other study procedures, and study restrictions\n* Evidence of a personally signed informed consent by patients \\>= 18 year old (YO) or parent or legally authorized representative (LAR) for patients 12-17 YO indicating that the subject is aware of the neoplastic nature of the disease and has been informed of the procedures to be followed, the experimental nature of the therapy, alternatives, potential risks and discomforts, potential benefits, and other pertinent aspects of study participation. Patients 12-17 will also be required to give assent to the process per institutional guidelines\n\nExclusion Criteria:\n\n* Prior malignancy, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer from which the subject has been disease free for \\>= 2 years or which will not limit survival to \\\u003C 2 years\n* Patients who have had chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events to =\\\u003C grade 1\n* Active autoimmune disease or history of autoimmune disease such as hepatitis, hypophysitis, nephritis, interstitial lung disease, and colitis\n* Active central nervous system (CNS) involvement with lymphoma\n* Patients with hepatitis B (positive hepatitis B virus surface antigen \\[HBsAg\\] or hepatitis B virus core antibody \\[HBcAb\\]) and those with positive hepatitis C virus (HCV) antibodies are not permitted to enroll\n* No active infection, or other active illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements","12 Years",{"count":51,"type":21},46,[24],"This phase II trial studies the effect of brentuximab vedotin and nivolumab in treating patients with classic Hodgkin lymphoma that has come back (relapsed) or does not respond to treatment (refractory) that have been previously treated with brentuximab vedotin or checkpoint inhibitors. Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. 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. Giving brentuximab vedotin and nivolumab in combination may be an effective treatment in patients with relapsed or refractory classic Hodgkin lymphoma previously treated with brentuximab vedotin or checkpoint inhibitors.",[28,29],"RECRUITING","2025-08-18",{"date":58,"type":34},"2025-08-22",{"date":60,"type":34},"2022-05-02",{"date":62,"type":21},"2027-11-30",{"name":64,"class":65},"Emory University","OTHER"]