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

Hodgkin Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06377566
• Other study ID #: 24-039
• Status: Recruiting
• Phase: Phase 2
• Start date: April 17, 2024
• Est. completion date: April 2027

Study information

• Verified date: April 2024
• Source: Memorial Sloan Kettering Cancer Center
• Contact: Robert Stuver, MD
• Phone: 646-608-4308
• Email: stuverr[@]mskcc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 71
• Est. completion date: April 2027
• Est. primary completion date: April 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hodgkin Disease
• Hodgkin Lymphoma
• Lymphoma

Intervention

Drug:
• Brentuximab vedotin
Brentuximab vedotin will be administered at 1.2 mg/kg IV on days 1 and 15 of each 28-day cycle
• Doxorubicin
Doxorubicin 25 mg/m^2 IV
• Vinblastine
Vinblastine 6 mg/m^2 IV
• Dacarbazine
Dacarbazine 375 mg/m^2 IV on days 1 and 15 of each 28-day cycle
• Pembrolizumab
Pembrolizumab will be administered at 200 mg IV (flat) on day 1
• Gemcitabine
Gemcitabine 1000 mg/m^2 IV (days 1 an
• Vinorelbine
Vinblastine 6 mg/m^2 IV

Diagnostic Test:
• FDG-PET/CT scan
After 2 cycles of therapy, patients will undergo FDG-PET/CT scan

Locations

Country	Name	City	State
United States	Memorial Sloan Kettering Basking Ridge (All Protocol Activities)	Basking Ridge	New Jersey
United States	Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)	Commack	New York
United States	Memorial Sloan Kettering Westchester (All Protocol Activities)	Harrison	New York
United States	University of Miami	Miami	Florida
United States	Memorial Sloan Kettering Monmouth (All Protocol Activities)	Middletown	New Jersey
United States	Memorial Sloan Kettering Bergen (All Protocol Activities)	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center (All Protocol Activities)	New York	New York
United States	Memorial Sloan Kettering Nassau (All Protocol Activities)	Uniondale	New York

Sponsors (2)

Lead Sponsor	Collaborator
Memorial Sloan Kettering Cancer Center	Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	progression-free survival		3 years
Secondary	overall survival		3 years

External Links

•   Memorial Sloan Kettering Cancer Center