- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01476410
Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma
A Phase II Trial of Sequential SGN-35 Therapy With Adriamycin, Vinblastine, and Dacarbazine (S-AVD) for Older Patients With Untreated Hodgkin Lymphoma
Study Overview
Status
Conditions
Intervention / Treatment
- Procedure: quality-of-life assessment
- Radiation: fludeoxyglucose F 18
- Procedure: positron emission tomography
- Drug: doxorubicin hydrochloride
- Other: laboratory biomarker analysis
- Other: immunohistochemistry staining method
- Drug: dacarbazine
- Drug: brentuximab vedotin
- Drug: vinblastine
- Genetic: DNA analysis
- Genetic: RNA analysis
- Genetic: polymorphism analysis
Detailed Description
LEAD IN: Patients receive brentuximab vedotin intravenously (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.
After completion of study treatment, patients are followed up at 30 days.
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
California
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Stanford, California, United States, 94305
- Stanford University Medical Center
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Chicago, Illinois, United States, 60611
- NorthwesternU
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Massachusetts
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Boston, Massachusetts, United States, 02111
- Tufts Medical Center
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Nebraska
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Omaha, Nebraska, United States, 68198-7835
- University of Nebraska Medical Center
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New York
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New York, New York, United States, 10065
- Memorial Sloan- Kettering Cancer Center
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Texas
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Houston, Texas, United States, 77030
- MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Voluntary written informed consent before performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care
- 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:
- Previous treatment with brentuximab vedotin or any other prior anti-CD30-based antibody therapy
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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. |
Ancillary studies
Other Names:
Correlative studies
Other Names:
Correlative studies
Other Names:
Given IV
Other Names:
Optional correlative studies
Optional correlative studies
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Given IV
Other Names:
Optional correlative studies
Optional correlative studies
Optional correlative studies
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate after chemotherapy
Time Frame: 2 years
|
The primary objective of this study is to assess the overall response rate among older patients with HL receiving sequential brentuximab vedotin therapy with AVD chemotherapy
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall response rate
Time Frame: Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study
|
Overall response rate progression-free survival (PFS), time to treatment failure (TTF), freedom from progression (FFP), and overall survival (OS) rates following SGN-35/AVD sequential therapy.
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Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study
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Overall response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD])
Time Frame: Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study
|
Estimates of response rate based on best response (CR and PR) and the tumor local control rate (CR, PR, and stable disease [SD])
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Baseline, every 3 weeks during the first 2 cycles, every 2 weeks during next 6 cycles, every 4 weeks furing the last 4 cycles, and then every 3 months for up to 3 years from entering the study
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Leo Gordon, MD, Northwestern University
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Lymphoma
- Hodgkin Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Antineoplastic Agents, Phytogenic
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antineoplastic Agents, Immunological
- Radiopharmaceuticals
- Antibiotics, Antineoplastic
- Fluorodeoxyglucose F18
- Antibodies
- Immunoglobulins
- Doxorubicin
- Liposomal doxorubicin
- Antibodies, Monoclonal
- Dacarbazine
- Brentuximab Vedotin
- Vinblastine
- Immunoconjugates
Other Study ID Numbers
- NU 11H01
- NCI-2011-00684 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- STU00046908 (Other Identifier: Northwestern University IRB)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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