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|NCT02227433 : A Phase II Study of Brentuximab Vedotin (BV) in the Treatment of Elderly Hodgkin Lymphoma (HL) Patients at First Relapse or With Primary Refractory Disease.|
|Ages||Min: 60 Years Max: N/A|
1. Histologically confirmed CD30-positive disease
2. Elderly patients at first relapse or with primary refractory HL (i.e. patients who
have previously received only 1 line of treatment.
3. Patients must have completed any prior treatment with radiation, chemotherapy,
biologics, immunotherapy and/or other investigational agents greater than 5
half-lives of the last dose of that prior treatment prior to the first dose of BV and
must have fully recovered from the acute toxic effects prior to entering this study.
4. Age greater than or equal to 60 years.
5. Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented
by both PET and spiral CT.
6. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
7. The following required baseline laboratory data: absolute neutrophil count (ANC)
?1500/µL, unless known marrow involvement due to disease, platelets ?75,000/µL,
unless known marrow involvement due to disease, bilirubin ?1.5X upper limit of normal
(ULN) or ?3X ULN for patients with Gilbert's disease, serum creatinine ?1.5X ULN,
alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ?2.5X ULN.
8. Females of childbearing potential must have a negative serum or urine ?-hCG pregnancy
test result prior to the first dose of brentuximab vedotin. Females of
non-childbearing potential are those who are postmenopausal greater than 1 year or
who have had a bilateral tubal ligation or hysterectomy.
9. Females of childbearing potential must agree to use two effective contraceptive
methods during the study and for 6 months following the last dose of study drug or
agree to completely abstain from heterosexual intercourse.
10. Males, even if surgically sterilized, (i.e., status post vasectomy) must agree to
practice effective barrier contraception during the entire study period and through 6
months after the last dose of study drug or agree to completely abstain from
11. Patients must provide written informed consent.
1. Previous treatment with BV
2. Peripheral neuropathy > grade 1.
3. Known history of any of the following cardiovascular conditions:
1. Myocardial infarction within 2 years of study entry.
2. Congestive heart failure, Class III or IV, by the NYHA criteria.
3. Evidence of current uncontrolled cardiac arrhythmias, angina, or
electrocardiographic evidence of acute ischemia or active conduction system
4. Recent evidence (within 6 months of study entry) of a left ventricular ejection
fraction <50%4) History of another primary malignancy for within 3 years of
study entry. (The following are exempt from the 3-year limit: nonmelanoma skin
cancer, curatively treated localized prostate cancer, and cervical carcinoma in
situ on biopsy or a squamous intraepithelial lesion on PAP smear.)
5) Known cerebral/meningeal disease. 6) Signs or symptoms of progressive multifocal
leukoencephalopathy (PML). 7) Any active systemic viral, bacterial, or fungal infection
requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of
BV. 8) Current therapy with other systemic anti-neoplastic or investigational agents.
9) Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone
equivalent within 1 week prior to the first dose of BV. 10) Women who are pregnant or
lactating and breastfeeding. 11) Patients with a known hypersensitivity to recombinant
proteins, murine proteins, or any excipient contained in the drug formulation of
brentuximab vedotin. 12) Known human immunodeficiency virus (HIV) positive. 13) Known
hepatitis B surface antigen positive, or known or suspected active hepatitis C infection.
14) Patients with dementia or an altered mental state that would preclude the
understanding and rendering of informed consent.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02227433
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