Treatment for early stage bulky Hodgkin lymphoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of a treatment regimen combining Brentuximab vedotin (an antibody-drug conjugate) with AVD (doxorubicin, vinblastine, and dacarbazine) in patients with newly diagnosed, early stage bulky Hodgkin lymphoma. The treatment targets CD30-positive cancer cells, aiming to slow or stop cancer growth. Participants must have a confirmed diagnosis and meet specific health criteria, including certain imaging results and performance status. The study is interventional and is currently in Phase 2.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Histological diagnosis of classical, CD30-positive Hodgkin lymphoma confirmed at enrolling institution.
* Ann Arbor stage I or II FDG-avid disease by FDG-PET/CT.
* Disease bulk defined as any lymph node mass with transverse maximal diameter ≥ 7.0 cm or coronal maximal diameter ≥ 7.0 cm on CT imaging.
* Age 18 and over.
* ECOG Performance Status ≤ 2
* Females of childbearing age must be on an acceptable form of birth control per institutional standards during the treatment period.
* Males must consistently use an acceptable form of contraception per institutional standards during the treatment period.

Exclusion Criteria:

* Prior systemic therapy or radiation therapy for Hodgkin lymphoma (excluding corticosteroids)
* Cardiac ejection fraction \< 50% as measured by echocardiogram.
* Platelet count ≤ 75,000/µL.
* Hemoglobin level ≤ 7.0 mg/dL.
* Absolute neutrophil count ≤ 1.0 K/µL.
* Serum creatinine clearance \< 30 mL/minute as estimated by the Cockcroft-Gault Method.
* Transaminase levels \> 3 times the upper limit of normal in the absence of a history of Gilbert's disease or hepatic involvement. In patients with Gilbert's disease, \> 5 times the upper limit of normal is exclusionary.
* Total bilirubin ≥ 1.5 the upper limit of normal in the absence of a history of Gilbert's disease or hepatic involvement. In patients with Gilbert's disease, \> 3 times the upper limit of normal is exclusionary.
* Pre-existing peripheral neuropathy ≥ grade 2 prior to participation.
* Known pregnancy or breast-feeding
* Active viral infection with hepatitis B or hepatitis C. For hepatitis B, patients who are seropositive (hepatitis B core Ab positive) are permitted if HBV DNA is negative by PCR. For hepatitis C, patients who are seropositive (hepatits C Ab positive) are eligible if HCV DNA is negative by PCR and curative therapy has been completed.
* Concurrent malignancy requiring active therapy within the last 2 years with the exception of basal cell or squamous cell carcinoma limited to the skin, carcinoma in situ of the cervix, breast or localized prostate cancer. Adjuvant hormonal therapy for cancer previously treated for curative intent is permitted.
* Patients with autoimmune conditions requiring active, ongoing systemic immunosuppressive therapy.
* Medical illness unrelated to Hodgkin lymphoma which in the opinion of the treating physician and/or principal investigator makes participation inappropriate.

Note: Patients with HIV infection are permitted to enroll but are required to be on antiretroviral regimens that are in accordance with the current International AIDS Society guidelines concurrently with chemotherapy. Use of experimental antiretroviral agents or those containing zidovudine or ritonavir, cobicistat or similar potent CYP3 inhibitors are prohibited. In order to be eligible, patients taking zidovudine or ritonavir, or cobicistat or other CYP3 inhibitors must change to a different regimen 7 days prior to therapy initiation. Subjects must be on HAART for at least 12 weeks prior to therapy.

Note: Patients with pre-existing autoimmune conditions are NOT excluded unless there is an autoimmune condition requiring active, ongoing systemic immunosuppressive therapy. However, careful consideration should be given to patients with pre-existing autoimmune conditions who may need pembrolizumab. Any concerns regarding patients with pre-existing autoimmune conditions and eligibility should be reviewed with the study PI.

Where it's running

• Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activities)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Robert Stuver, MD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Robert Stuver, MD
• Email: stuverr@mskcc.org
• Phone: 646-608-4308

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.