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Doxorubicin Hydrochloride, Vinblastine, Dacarbazine, Brentuximab Vedotin, and Nivolumab in Treating Patients with Stage I-II Hodgkin Lymphoma

This phase II trial evaluates how well AVD (doxorubicin hydrochloride, vinblastine, dacarbazine) in combination with brentuximab vedotin and nivolumab work in treating patients with stage I-II Hodgkin lymphoma. Drugs used in the chemotherapy, such as doxorubicin hydrochloride, vinblastine, dacarbazine, and brentuximab vedotin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, and / or by stopping them from spreading. Targeted agent, such as nivolumab, may interfere with the ability of cancer cells to grow and spread by enhancing the immune system. Giving doxorubicin hydrochloride, vinblastine, dacarbazine, brentuximab vedotin, and nivolumab may improve survival of patients with stage I-II Hodgkin lymphoma.
Not Available
Phase II
Both
Not Available
Not Available
Reddy, Nishitha
National
Vanderbilt University
04-19-2019
Treatment
VICCPCL1896
NCT03233347

Eligibility

18 Years
BOTH
NO
Inclusion Criteria:

Measurable disease (>= 1.5 cm) as assessed by 2 dimensional measurement by computed tomography (CT)

Previously untreated stage I or II non-bulky (defined as a mass measuring
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2

Life expectancy >= 3 months

Documented negative serologic testing for human immunodeficiency virus (HIV), hepatitis B (unless serologically positive due to prior vaccination), and hepatitis C =
Carbon monoxide diffusing capability (DLCO) > 60% (hemoglobin adjusted) by pulmonary function test (PFT)s

White blood cell >= 2,000 /mm^3 without transfusion support > 7 days prior to registration

Hemoglobin >= 8.5 g/dL without transfusion support > 7 days prior to registration

Absolute neutrophil count (ANC) >= 1,000 cells/mm^3 without transfusion support > 7 days prior to registration

Platelet count >= 75,000/mm^3 without transfusion support > 7 days prior to registration

Alanine and aspartate aminotransferase (ALT/AST) =
Total serum bilirubin =
Serum creatinine == 40 ml/min for subject with creatinine levels > 1.5 x institutional ULN (per Cockcroft-Gault formula) obtained =
Negative serum pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin [HCG]) within 7 days prior to registration in women of child-bearing potential (WOCBP)

Sexually active female of reproductive capability ie, WOCBP, has agreed to use a medically accepted form of contraception from time of registration to completion of study therapy through 24 weeks (6 months) after last dose of NVB or BV; Note: Females of non-child-bearing potential are those who are postmenopausal for > 1 year or who have had a bilateral tubal ligation or hysterectomy

Male subjects agree to use an adequate method of contraception starting with the first dose of study therapy through 31 weeks after the last dose of study therapy

Provide informed written consent

Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study) * Note: During the active monitoring phase of a study (i.e., active treatment and observation), participants must be willing to return to the consenting institution for follow-up



Exclusion Criteria:

Any of the following: * Pregnant women * Nursing women * Men or women of childbearing potential who are unwilling to employ adequate contraception

Prior therapies including involved field radiation therapy

Bulky disease (defined as a nodal mass measuring >= 10 cm by CT)

Known central nervous system (CNS) involvement

Moderate or severe hepatic insufficiency Child-Pugh score > 6

Severe renal impairment (i.e. creatinine clearance
Symptomatic cardiac disease including ventricular dysfunction, left ventricular ejection fraction
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy =
Known history of active TB (Bacillus tuberculosis)

Requires therapy with agents that have a predisposition for hepatoxicity

Hypersensitivity to NVB or any of its excipients or to any component of AVD + BV therapy

Requires immunosuppressive doses of corticosteroid therapy (> 10 mg/day prednisone equivalents) for >= 2 weeks prior to registration

Active, known, or suspected autoimmune disease that requires systemic treatment (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs); Note: Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment; subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger

Active infection requiring systemic IV antibiotic therapy

History of Steven’s Johnson’s syndrome, toxic epidermal necrolysis syndrome (TENs) or motor neuropathy

History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator

Known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial

Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent

Known history of human immunodeficiency virus (HIV) (HIV 1/2 antibodies)

Known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [RNA] [qualitative] is detected)

Received a live vaccine == 2 weeks prior to registration

History of allergies and adverse drug reaction to study drug components

History of another primary malignancy that has not been in remission for at least 3 years; (Note: The following are exempt for the 3-year limit: nonmelanoma skin cancer, fully excised melanoma in situ [stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on papanicolaou [PAP] smear)

Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm

History of progressive promyelocytic leukemia (PML), known history of pancreatitis, active grade 3 or higher viral, bacterial or fungal infection =

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