Trial Title:
A Study of BV-AVD in People With Bulky Hodgkin Lymphoma
NCT ID:
NCT06377566
Condition:
Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Gemcitabine
Pembrolizumab
Doxorubicin
Vinorelbine
Dacarbazine
Brentuximab Vedotin
Vinblastine
Conditions: Keywords:
Ann Arbor stage I or II
Brentuximab vedotin
Doxorubicin HCL
Vinblastine Sulfate
Dacarbazine
Pembrolizumab
Gemcitabine
Vinorelbine
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
This is a multicenter, investigator-initiated, single-arm phase II trial.
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Brentuximab vedotin
Description:
Brentuximab vedotin will be administered at 1.2 mg/kg IV on days 1 and 15 of each 28-day
cycle
Arm group label:
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
Intervention type:
Drug
Intervention name:
Doxorubicin
Description:
Doxorubicin 25 mg/m^2 IV
Arm group label:
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
Intervention type:
Drug
Intervention name:
Vinblastine
Description:
Vinblastine 6 mg/m^2 IV
Arm group label:
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
Intervention type:
Drug
Intervention name:
Dacarbazine
Description:
Dacarbazine 375 mg/m^2 IV on days 1 and 15 of each 28-day cycle
Arm group label:
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
Intervention type:
Drug
Intervention name:
Pembrolizumab
Description:
Pembrolizumab will be administered at 200 mg IV (flat) on day 1
Arm group label:
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
Intervention type:
Drug
Intervention name:
Gemcitabine
Description:
Gemcitabine 1000 mg/m^2 IV (days 1 an
Arm group label:
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
Intervention type:
Drug
Intervention name:
Vinorelbine
Description:
Vinblastine 6 mg/m^2 IV
Arm group label:
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
Intervention type:
Diagnostic Test
Intervention name:
FDG-PET/CT scan
Description:
After 2 cycles of therapy, patients will undergo FDG-PET/CT scan
Arm group label:
BV-AVD (brentuximab vedotin, doxorubicin, vinblastine, dacarbazine)
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.
Criteria for eligibility:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Miami
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Craig Moskowitz, MD
Phone:
305-243-5302
Facility:
Name:
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Address:
City:
Basking Ridge
Zip:
07920
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Stuver, MD
Phone:
646-608-4308
Facility:
Name:
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Address:
City:
Middletown
Zip:
07748
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Stuver, MD
Phone:
646-608-4308
Facility:
Name:
Memorial Sloan Kettering Bergen (All Protocol Activities)
Address:
City:
Montvale
Zip:
07645
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Stuver, MD
Phone:
646-608-4308
Facility:
Name:
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Address:
City:
Commack
Zip:
11725
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Stuver, MD
Phone:
646-608-4308
Facility:
Name:
Memorial Sloan Kettering Westchester (All Protocol Activities)
Address:
City:
Harrison
Zip:
10604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Stuver, MD
Phone:
646-608-4308
Facility:
Name:
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
Address:
City:
New York
Zip:
10065
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Stuver, MD
Phone:
646-608-4308
Facility:
Name:
Memorial Sloan Kettering Nassau (All Protocol Activities)
Address:
City:
Uniondale
Zip:
11553
Country:
United States
Status:
Recruiting
Contact:
Last name:
Robert Stuver, MD
Phone:
646-608-4308
Start date:
April 17, 2024
Completion date:
April 2027
Lead sponsor:
Agency:
Memorial Sloan Kettering Cancer Center
Agency class:
Other
Collaborator:
Agency:
Seagen Inc.
Agency class:
Industry
Source:
Memorial Sloan Kettering Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06377566
http://www.mskcc.org/mskcc/html/44.cfm
