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Treatment for early stage bulky Hodgkin lymphoma

BV-AVD in Patients With Newly-Diagnosed, Early Stage, Bulky Hodgkin Lymphoma Using a PET-adapted and MTV-guided Approach

Phase 2 Interventional Memorial Sloan Kettering Cancer Center · NCT06377566

This study is testing a new treatment that combines a targeted drug with standard chemotherapy to see if it helps people with early stage bulky Hodgkin lymphoma.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment71 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionspembrolizumab, chemotherapy, radiation, doxorubicin
Locations8 sites (Miami, Florida and 7 other locations)
Trial IDNCT06377566 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and over with newly diagnosed, classical, CD30-positive Hodgkin lymphoma at Ann Arbor stage I or II.

Not a fit: Patients who have previously received systemic therapy or radiation for Hodgkin lymphoma will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a more effective option for patients with early stage bulky Hodgkin lymphoma.

How similar studies have performed: Other studies have shown promise with similar antibody-drug conjugate approaches, indicating potential for success in this treatment strategy.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Miami, Florida and 7 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hodgkin LymphomaAnn Arbor stage I or IIBrentuximab vedotinDoxorubicin HCLVinblastine SulfateDacarbazinePembrolizumabGemcitabine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.