Phase
Condition
Lymphoma
Marginal Zone Lymphoma
Hematologic Cancer
Treatment
Dacarbazine
Brentuximab vedotin
Vinorelbine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Histological diagnosis of classical, CD30-positive Hodgkin lymphoma confirmed atenrolling 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 ≥ 7.0cm 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 perinstitutional standards during the treatment period.
Males must consistently use an acceptable form of contraception per institutionalstandards during the treatment period.
Exclusion
Exclusion Criteria:
Prior systemic therapy or radiation therapy for Hodgkin lymphoma (excludingcorticosteroids)
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-GaultMethod.
Transaminase levels > 3 times the upper limit of normal in the absence of a historyof Gilbert's disease or hepatic involvement. In patients with Gilbert's disease, > 5times the upper limit of normal is exclusionary.
Total bilirubin ≥ 1.5 the upper limit of normal in the absence of a history ofGilbert's disease or hepatic involvement. In patients with Gilbert's disease, > 3times 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, patientswho are seropositive (hepatitis B core Ab positive) are permitted if HBV DNA isnegative by PCR. For hepatitis C, patients who are seropositive (hepatits C Abpositive) are eligible if HCV DNA is negative by PCR and curative therapy has beencompleted.
Concurrent malignancy requiring active therapy within the last 2 years with theexception of basal cell or squamous cell carcinoma limited to the skin, carcinoma insitu of the cervix, breast or localized prostate cancer. Adjuvant hormonal therapyfor cancer previously treated for curative intent is permitted.
Patients with autoimmune conditions requiring active, ongoing systemicimmunosuppressive therapy.
Medical illness unrelated to Hodgkin lymphoma which in the opinion of the treatingphysician 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.
Study Design
Connect with a study center
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Memorial Sloan Kettering Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey 07920
United StatesActive - Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey 07748
United StatesActive - Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey 07645
United StatesActive - Recruiting
Memorial Sloan Kettering Suffolk - Commack (All Protocol Activities)
Commack, New York 11725
United StatesActive - Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York 10604
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York 10065
United StatesActive - Recruiting
Memorial Sloan Kettering Nassau (All Protocol Activities)
Uniondale, New York 11553
United StatesActive - Recruiting
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