| Title |
A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy |
| Protocole ID |
SGN35-015 |
| ClinicalTrials.gov ID |
NCT01716806 |
| Cancer Type(s) |
Hodgkin's Disease |
| Phase |
Phase II |
| Stage |
|
| Study Type |
Clinical |
| Drug |
Brentuximab Vedotin |
| Institution |
CENTRE UNIVERSITAIRE DE SANTE MCGILL
 SITE GLEN
1001 boul. Décarie , Montréal, QC, H4A 3J1
|
| City |
|
| Principal Investigator |
Dr. Kelly Davison
|
| Coordinator |
|
| Status |
Recruiting |
| Activation Date |
|
| Eligibility Criteria |
- Parts A, B, C, and D: 60 years of age or older
- Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E)
- Treatment-naive patients with CD30-expressing PTCL (Part F)
- Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D)
-
Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by:
- A CIRS score of 10 or greater
- Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs)
- Measurable disease of at least 1.5 cm as documented by radiographic technique
- Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D)
|
| Exclusion Criteria |
- Symptomatic neurologic disease compromising IADLs or requiring medication
- History of progressive multifocal leukoencephalopathy
- Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin
- Concurrent use of other investigational agents
- Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug
- History of another malignancy within 1 year before first dose of study drug (Parts E and F only)
-
Part D only:
- Received any prior immune-oncology therapy
- History of known or suspected autoimmune disease
- Prior allogeneic stem cell transplant
- History of cerebral vascular event within 6 months of first dose of study drug
- Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology
- Known history of pancreatitis
-
Parts D, E, and F only:
- Known cerebral/meningeal disease related to the underlying malignancy
- Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
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Groupe d'étude en oncologie du Québec