A Study of BV-AVD in People With Bulky Hodgkin Lymphoma

Conditions

• Hodgkin Lymphoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Brentuximab vedotin — DRUG
  Brentuximab vedotin will be administered at 1.2 mg/kg IV on days 1 and 15 of each 28-day cycle
• Doxorubicin — DRUG
  Doxorubicin 25 mg/m\^2 IV
• Vinblastine — DRUG
  Vinblastine 6 mg/m\^2 IV
• Dacarbazine — DRUG
  Dacarbazine 375 mg/m\^2 IV on days 1 and 15 of each 28-day cycle
• Pembrolizumab — DRUG
  Pembrolizumab will be administered at 200 mg IV (flat) on day 1
• Gemcitabine — DRUG
  Gemcitabine 1000 mg/m\^2 IV (days 1 an
• Vinorelbine — DRUG
  Vinblastine 6 mg/m\^2 IV
• FDG-PET/CT scan — DIAGNOSTIC_TEST
  After 2 cycles of therapy, patients will undergo FDG-PET/CT scan

Study Details

The purpose of this study is to test whether BV-AVD is an effective treatment in people with early stage, bulky Hodgkin lymphoma that was recently diagnosed and who have not yet received any treatments for their disease. BV is a type of drug called an antibody-drug conjugate (ADC). ADCs are a substance made up of a monoclonal antibody chemically linked to a drug. Antibodies are proteins made by the immune system to fight infections and other possible harms to the body. The monoclonal antibody binds to specific proteins or receptors found on certain types of cells, including cancer cells. The linked drug enters these cells and kills them without harming other cells. Researchers think BV may be an effective treatment for this type of cancer because the drug targets cells that have CD30, which play a role in cancer cell growth. By destroying these cells, BV may help slow or stop the growth of the cancer. AVD (doxorubicin, vinblastine, and dacarbazine) is a treatment regimen that works by stopping the growth of cancer cells, either by killing the cells or by stopping them from dividing. The researchers think that BV in combination with AVD may work better than AVD alone to slow or stop the growth of the cancer.

Key Dates

Start date

Apr 17, 2024

Status verified

Apr 2026

Primary completion

Apr 30, 2027

Completion

Apr 30, 2027

Study Design

Enrollment

71 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
  All patients will receive 2 cycles of brentuximab vedotin (BV) in combination with AVD chemotherapy (doxorubicin, vinblastine, dacarbazine). Prophylactic growth factor support will be mandated with each cycle. After 2 cycles of therapy, patients will undergo FDG-PET/CT scan (PET2). Patients with disease progression (Deauville 4 or 5) will be taken off study. Patients who achieve a PETnegative scan (Deauville score of ≤ 3) will receive 2 additional cycles of BV-AVD with no further therapy. In those with partial response or stable disease (Deauville score of 4 or 5), patients will be stratified by baseline metabolic tumor volume (bMTV) as bMTV-high (\> 150 cm3 ) or bMTV-low (≤ 150 cm3 ) as measured on pre-treatment FDG-PET/CT. In the bMTV-low group, patients will receive an additional 2 cycles of BV-AVD in combination with radiation therapy.

Primary Outcome Measure

progression-free survival [ Time Frame: 3 years ]

Central Contacts

• Robert Stuver, MD
  646-608-4308
  [email protected]
• Alison Moskowitz, MD
  646-608-3726

Locations (8)

Find similar trials in Miami, FL

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