Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma
NCT ID: NCT01476410
Last Updated: 2020-02-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
48 participants
INTERVENTIONAL
2011-11-30
2021-05-31
Brief Summary
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Detailed Description
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AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (antibody-drug conjugate and combination chemo)
LEAD-IN: Patients receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.
AVD CHEMOTHERAPY: Patients then receive doxorubicin hydrochloride IV, vinblastine IV, and dacarbazine IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity.
CONSOLIDATION: Patients achieving CR receive brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
brentuximab vedotin
Given IV
doxorubicin hydrochloride
Given IV
vinblastine
Given IV
dacarbazine
Given IV
quality-of-life assessment
Ancillary studies
DNA analysis
Optional correlative studies
RNA analysis
Optional correlative studies
fludeoxyglucose F 18
Correlative studies
positron emission tomography
Correlative studies
laboratory biomarker analysis
Optional correlative studies
immunohistochemistry staining method
Optional correlative studies
polymorphism analysis
Optional correlative studies
Interventions
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brentuximab vedotin
Given IV
doxorubicin hydrochloride
Given IV
vinblastine
Given IV
dacarbazine
Given IV
quality-of-life assessment
Ancillary studies
DNA analysis
Optional correlative studies
RNA analysis
Optional correlative studies
fludeoxyglucose F 18
Correlative studies
positron emission tomography
Correlative studies
laboratory biomarker analysis
Optional correlative studies
immunohistochemistry staining method
Optional correlative studies
polymorphism analysis
Optional correlative studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Previously untreated classical Hodgkin lymphoma (i.e., nodular sclerosis, mixed cellularity, lymphocyte depleted, lymphocyte-rich, and not otherwise specified \[NOS\]); nodular lymphocyte predominant Hodgkin lymphoma is not eligible
* Stage II, III, and IV disease by Ann Arbor classification
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2
* Patients must have bi-dimensional measurable disease documented in the lymphoma baseline tumor assessment form within 30 days prior to registration (at least 1.5 cm); patients with non-measurable disease in addition to measurable disease must have been assessed within 60 days prior to registration
* Patients must have a bone marrow biopsy (bilateral preferred, unilateral acceptable) within 60 days prior to registration
* Patients must have a multi gated acquisition scan (MUGA) or echocardiogram within 60 days prior to study registration and the ejection fraction must be \>= 45%
* Absolute neutrophil count (ANC) \> 1000/mm\^3
* Platelet count \> 75,000/mm\^3
* Creatinine \< 2.5 mg/dl
* Bilirubin \< 3.0 mg/dl
* Patients with documented marrow involvement by lymphoma at the time of registration are not required to meet the above hematologic parameters
* Patients must not have received prior chemotherapy or radiation therapy for the treatment of Hodgkin lymphoma
* Both females and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 30 days following the last dose of study drug
* Patients must sign the informed consent form before registration
Exclusion Criteria
* History of another primary malignancy that has not been in remission for at least 3 years; (the following are exempt from the 3-year limit: early stage \[stage I or II\] breast cancer treated with surgery and radiation +/- hormones \[without adjuvant chemotherapy\], non-melanoma 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 test \[PAP smear\])
* Known cerebral/meningeal disease
* Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first dose
* Patients with hepatitis B surface antigen (HBsAg) positive hepatitis B virus (HBV) infection; patients with prior history of hepatitis B infection, but immune, with only Immunoglobulin G (IgG) hepatitis core antibody + (HBcAb +) must receive anti-viral prophylaxis (e.g., lamivudine 100mg orally \[po\] daily) for at least 1 week prior to cycle 1 and throughout induction and continuation therapy and for at least 6 months after the last brentuximab vedotin dose; in addition, consultation with a hepatologist is recommended
* Patients with a known hypersensitivity to any excipient contained in the drug formulation
* Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent
60 Years
ALL
No
Sponsors
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Robert H. Lurie Cancer Center
OTHER
Seagen Inc.
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Principal Investigators
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Leo Gordon, MD
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Stanford University Medical Center
Stanford, California, United States
NorthwesternU
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Memorial Sloan- Kettering Cancer Center
New York, New York, United States
MD Anderson Cancer Center
Houston, Texas, United States
Countries
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References
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Evens AM, Advani RH, Helenowski IB, Fanale M, Smith SM, Jovanovic BD, Bociek GR, Klein AK, Winter JN, Gordon LI, Hamlin PA. Multicenter Phase II Study of Sequential Brentuximab Vedotin and Doxorubicin, Vinblastine, and Dacarbazine Chemotherapy for Older Patients With Untreated Classical Hodgkin Lymphoma. J Clin Oncol. 2018 Oct 20;36(30):3015-3022. doi: 10.1200/JCO.2018.79.0139. Epub 2018 Sep 4.
Other Identifiers
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NCI-2011-00684
Identifier Type: REGISTRY
Identifier Source: secondary_id
STU00046908
Identifier Type: OTHER
Identifier Source: secondary_id
NU 11H01
Identifier Type: -
Identifier Source: org_study_id
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