E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients who were on the placebo arm and experienced progression of Hodgkin`s lymphoma while participating in the SGN35-005 clinical study |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020328 |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• To provide the option of treatment with brentuximab vedotin for those patients on the placebo arm in study SGN35-005 who experience progression of Hodgkin lymphoma (HL) • To assess the safety and tolerability of brentuximab vedotin |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients who met all inclusion/exclusion criteria for and participated in the SGN35-005 clinical study. 2. Patients who were treated with placebo in the SGN35-005 clinical study after autologous hematopoietic stem cell transplantation (ASCT) and experienced progression of HL based on the Revised Response Criteria for Malignant Lymphoma (Cheson 2007) as defined by protocol in study SGN35-005. 3. Age greater than or equal to 18 years. 4. An Eastern Cooperative Oncology Group (ECOG) performance status ≤2. 5. 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. 6. Females of childbearing potential must have a negative serum or urine β-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. 7. 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 30 days following the last dose of study drug. 8. The following baseline laboratory values are required: absolute neutrophil count (ANC) ≥1000/μL, platelets ≥50,000/μL, 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. 9. Patients or their legally authorized representative must provide written informed consent. |
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E.4 | Principal exclusion criteria |
1. Any Grade 3 viral, bacterial, or fungal infection requiring treatment with therapy within 1 week prior to the first study dose. 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. 5. Current therapy with other systemic anti-neoplastic or investigational agents. 6. Women who are pregnant or lactating. 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 who are eligible for participation in other clinical studies of brentuximab vedotin at their institution. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The safety endpoints are the type, incidence, severity, seriousness, and study drug relatedness of adverse events (AEs). |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 19 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 4 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |