Status:
UNKNOWN
Brentuximab Vedotin and Combination Chemotherapy in Treating Older Patients With Previously Untreated Stage II-IV Hodgkin Lymphoma
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
Robert H. Lurie Cancer Center
Seagen Inc.
Conditions:
Adult Lymphocyte Depletion Hodgkin Lymphoma
Adult Lymphocyte Predominant Hodgkin Lymphoma
Eligibility:
All Genders
60+ years
Phase:
PHASE2
Brief Summary
This phase II trial studies how well giving brentuximab vedotin together with combination chemotherapy works in treating older patients with previously untreated stage II-IV Hodgkin lymphoma (HL). Mon...
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....
Eligibility Criteria
Inclusion
- 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performance of any study-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to future medical care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
- 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
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2021
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01476410
Start Date
November 1 2011
End Date
May 1 2021
Last Update
February 17 2020
Active Locations (7)
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1
Stanford University Medical Center
Stanford, California, United States, 94305
2
NorthwesternU
Chicago, Illinois, United States, 60611
3
University of Chicago
Chicago, Illinois, United States, 60637
4
Tufts Medical Center
Boston, Massachusetts, United States, 02111