Phase
Condition
Marginal Zone Lymphoma
Hematologic Cancer
Lymphoma
Treatment
Doxorubicin
Vinblastine
Brentuximab Vedotin
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
- Treatment-naïve, Hodgkin lymphoma (HL) participants with Ann Arbor Stage 3 or 4 disease.
Note: Participants must have histologically confirmed classical HL according to the current world health organization classification.
Participants must have bidimensional measurable disease as documented by radiographic technique (spiral computed tomography [CT] preferred) per the international working group revised criteria for response assessment for malignant lymphoma.
Male or female participants 18 years or older.
Eastern cooperative oncology group (ECOG) performance status less than or equal to (≤)2.
Female participants who:
Are postmenopausal for at least 1 year before the screening visit, OR
Are surgically sterile, OR
If they are of childbearing potential, agree to practice 1 highly effective method and 1 additional effective (barrier) method of contraception at the same time, from the time of signing of the informed consent form (ICF) through 6 months after the last dose of study drug, OR
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
- Male participants, even if surgically sterilized (i.e., status post-vasectomy), who:
Agree to practice effective barrier contraception during the entire study treatment period and through 6 months after the last dose of study drug, OR
Agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, post-ovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).
Voluntary written consent must be given before performance of any study-related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the participant at any time without prejudice to future medical care.
Clinical laboratory values as specified below within 7 days before the first dose of study drug:
Absolute neutrophil count greater than or equal to (≥)1,000 per microliter (1,000/μL) unless there is known HL marrow involvement
Platelet count ≥75,000/μL unless there is known HL marrow involvement
Total bilirubin must be lesser than (<)1.5 x upper limit of the normal range (ULN) unless the elevation is known to be due to Gilbert syndrome.
Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) must be <3.0 x ULN. An AST and ALT may be elevated up to 5 times the ULN if their elevation can be reasonably ascribed to the presence of HL in liver.
Note: Moderate or severe hepatic disease patients will be excluded based upon Child-Pugh criteria.
Serum creatinine must be <2.0 milligrams per deciliter (mg/dL) and/or creatinine clearance or calculated creatinine clearance >30 mL/minute (Cockcroft-Gault Equation).
Hemoglobin must be ≥8 grams per deciliter (g/dL).
Exclusion Criteria
Female participants who are both lactating and breastfeeding or who have a positive serum pregnancy test during the screening period or a positive pregnancy test on Day 1 before first dose of study drug.
Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.
Known cerebral or meningeal disease (HL or any other etiology), including signs or symptoms of progressive multifocal leukoencephalopathy (PML).
Symptomatic neurologic disease compromising normal activities of daily living or requiring medications.
Any sensory or motor peripheral neuropathy.
Any active systemic viral, bacterial, or fungal infection requiring systemic antibiotics within 2 weeks prior to first study drug dose.
Prior immunosuppressive chemotherapy, therapeutic radiation, or any immunotherapy (e.g., immunoglobulin replacement, other monoclonal antibody therapies) within 12 weeks of first study drug dose.
Previously treated with brentuximab vedotin.
Any contraindications to the concomitant chemotherapy regimens (doxorubicin, vinblastine, and dacarbazine).
Known hypersensitivity to recombinant proteins, murine proteins, or to any excipient contained in the drug formulation of brentuximab vedotin or any component of doxorubicin, vinblastine, and dacarbazine (AVD).
Known human immunodeficiency virus (HIV) positive.
Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.
Diagnosed or treated for another malignancy within 3 years before the first dose or previously diagnosed with another malignancy and have any evidence of residual disease. Participants with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
Any of the following cardiovascular conditions or values within 6 months before the first dose of study drug:
A left-ventricular ejection fraction <50%
Myocardial infarction within 2 years of enrollment
New York Heart Association (NYHA) Class 3 or 4 heart failure. Evidence of current uncontrolled cardiovascular conditions, including cardiac arrhythmias, congestive heart failure (CHF), angina, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities.
Study Design
Connect with a study center
HCG City Cancer Centre
Vijayawada, Andhra Pradesh 520002
IndiaActive - Recruiting
Gauhati Medical college and Hospital
Guwahati, Assam 781032
IndiaActive - Recruiting
Unique Hospital Multispeciality and Research Institute
Surat, Gujarat 395002
IndiaActive - Recruiting
HCG Cancer Centre
Bangalore, Karnataka 560027
IndiaSite Not Available
JIPMER
Puducherry, Kerala 605006
IndiaActive - Recruiting
HCG Manavata Cancer Centre
Nashik, Maharashtra 422002
IndiaSite Not Available
ACTREC
Navi Mumbai, Maharashtra 410210
IndiaSite Not Available
DMH
Pune, Maharashtra 411004
IndiaActive - Recruiting
Rajiv Gandhi Cancer Hospital
Delhi, New Delhi 110085
IndiaActive - Recruiting
NRS Medical college & Hospital, Kolkata
Kolkata, West Bengal 700014
IndiaActive - Recruiting
AIIMS
New Delhi, 110029
IndiaActive - Recruiting
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