An open-label, treatment-option protocol of brentuximab vedotinin patients with relapsed or refractory Hodgkin lymphoma,systemic anaplastic large cell lymphoma, or CD30-positivecutaneous T-cell lymphoma
- Conditions
- MedDRA - 10020328: Hodgkin's lymphomaMedDRA - 10011677: Cutaneous T-cell lymphomaMedDRA - 10065864: anaplastic large -cell lymphoma
- Registration Number
- DRKS00010124
- Lead Sponsor
- Seattle Genetics, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 377
1. a. Patients who met all inclusion/exclusion criteria for and participated in the SGN35-005 clinical study and experienced progression of HL based on the Revised Response Criteria for Malignant Lymphoma (Cheson 2007) as defined by protocol in study SGN35-005. OR b. In the US only, patients with relapsed or refractory HL (Amendment 5 and later, not applicable). OR c. In the US only, patients with relapsed or refractory systemic ALCL who have previously received frontline chemotherapy (CHOP or multi-agent chemotherapy regimens with curative intent) and documented anaplastic lymphoma kinase (ALK) status (Amendment 5 and later, not applicable). OR d. The following patients who met all inclusion/exclusion criteria for the C25001 study and experienced disease progression per IRF: patients on the control arm or patients on the experimental arm with an objective response at the time of discontinuation of brentuximab vedotin.2. Age greater than or equal to 18 years.
? Patients of age greater than or equal to 6 years may be enrolled at US sites. Permission from the Sponsor must be granted prior to enrollment for ages 6 years to <12 years.
3. An Eastern Cooperative Oncology Group (ECOG) performance status =2.
4. Patients must have completed any previous treatment with radiation, chemotherapy, biologics and/or investigational agents at least 4 weeks prior to the first dose of SGN-35, unless underlying disease is progressing on therapy.
5. Females of childbearing potential must have a negative serum or urine ß-hCG pregnancy test result within 7 days prior to the first dose of brentuximab vedotin. Females of non-childbearing potential are those who are postmenopausal for more than 1 year or who have had a bilateral tubal ligation or hysterectomy.
6. Both females of childbearing potential and males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and for 6 months following the last dose of study drug.
7. The following baseline laboratory values are required: absolute neutrophil count (ANC) =1000/µL, platelets =50,000/µL, total bilirubin =1.5 x upper limit of normal (ULN) or =3 x ULN for patients with Gilbert’s disease, serum creatinine =1.5 x ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) =2.5 x ULN. ALT and AST up to 5 x ULN is allowed for patients whose elevations can be reasonably ascribed to the presence of metastatic disease in the liver.
8. Patients or their legally authorized representative must provide written informed consent.
1. Any Grade 3 viral, bacterial, or fungal infection requiring treatment within 1 week prior to the first study dose. Prophylactic use of antibiotics is allowed.
2. Patients with = Grade 2 peripheral neuropathy.
3. 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: nonmelanoma 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 PAP smear.)
4. Known cerebral/meningeal disease, including history of progressive multifocal leukoencephalopathy (PML).
5. Current therapy with other systemic anti-neoplastic or investigational agents. Oral or topical steroid therapy is allowed for CTCL patients for short-term symptomatic management.
6. Women who are pregnant or lactating and breastfeeding.
7. Patients with a known hypersensitivity to any excipient contained in the drug formulation.
8. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent.
9. Patients in Eastern and Western Europe who are eligible for participation in other clinical studies of brentuximab vedotin at their institution (Amendment 5 and later, not applicable).
10. In the US only, patients who are eligible for participation in other Seattle Genetics sponsored clinical studies of brentuximab vedotin (Amendment 5 and later, not applicable).
11. Patients with previous allogeneic stem cell transplant if <100 days from prior allogeneic SCT, or have acute or chronic graft-versus-host disease (GvHD) or are receiving immunosuppressive therapy as treatment for or prophylaxis against GvHD.
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety endpoints are the type, incidence, severity, seriousness, and<br>study drug relatedness of adverse events (AEs).
- Secondary Outcome Measures
Name Time Method