RECRUITING

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

Conditions

Hodgkin Lymphoma Ann Arbor stage I or II Brentuximab vedotin Doxorubicin HCL Vinblastine Sulfate Dacarbazine Pembrolizumab Gemcitabine Vinorelbine

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2024-04-17

Study Completion:2027-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06377566

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

Robert Stuver, MD

CONTACT

646-608-4308

stuverr@mskcc.org

Alison Moskowitz, MD

CONTACT

646-608-3726

Principal Investigator

Robert Stuver, MD

PRINCIPAL_INVESTIGATOR

Memorial Sloan Kettering Cancer Center

Study Locations (Sites)

University of Miami

Miami, Florida, 33136

United States

Memorial Sloan Kettering Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920

United States

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748

United States

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645

United States

Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)

Commack, New York, 11725

United States

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

United States

Memorial Sloan Kettering Nassau (All Protocol Activities)

Uniondale, New York, 11553

United States

Collaborators and Investigators

Sponsor: Memorial Sloan Kettering Cancer Center

Robert Stuver, MD, PRINCIPAL_INVESTIGATOR, Memorial Sloan Kettering Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-17

Study Completion Date2027-04

Study Record Updates

Study Start Date2024-04-17

Study Completion Date2027-04

Terms related to this study

Keywords Provided by Researchers

Ann Arbor stage I or II
Brentuximab vedotin
Doxorubicin HCL
Vinblastine Sulfate
Dacarbazine
Pembrolizumab
Gemcitabine
Vinorelbine

Additional Relevant MeSH Terms

Hodgkin Lymphoma