Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
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RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Bleomycin Sulfate for Lugano Classification Limited Stage Hodgkin Lymphoma AJCC v8

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.

Official registry: https://clinicaltrials.gov/study/NCT05675410 · National Cancer Institute (NCI) · enrollment listed as 1,875

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Biospecimen Collection, Bleomycin Sulfate, or Brentuximab Vedotin. The registry lists allocation as randomized. 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.

They plan to enroll about 1,875 people at 419 sites. Taking part typically means taking a study drug (or dummy pill), an infusion or injection of a biologic, a procedure as part of the study plus check-ins.

Official title (unrewritten)

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

Interventions: 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

Primary outcome (registry wording): Progression-free survival (PFS) in rapid early responder (RER) patients

Who it is for (from inclusion criteria)

  • Ages 5 Years to 60 Years
  • 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

Contact

No central phone on the registry card. Use the official listing to reach a site.

Sites listed on ClinicalTrials.gov

419 listed

+ 15 sites outside the US on the same record

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FAQ about this NCT record

Is NCT05675410 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT05675410?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT05675410?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary