E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Relapsed or refractory Hodgkin Lymphoma (HL) |
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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 |
E.1.2 | Term | Hodgkin's lymphoma |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To determine the antitumor efficacy of single-agent SGN-35 (1.8 mg/kg administered intravenously every 3 weeks) as measured by the overall objective response rate in patients with relapsed or refractory Hodgkin lymphoma following autologous stem cell transplant |
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E.2.2 | Secondary objectives of the trial |
To assess duration of tumor control, including duration of response and progression-free survival To assess survival To assess the safety and tolerability of SGN-35 To assess the pharmacokinetics of SGN-35 Additional: To assess disease-related symptoms To explore the correlation of potential biomarkers with clinical outcomes |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients with relapsed or refractory HL who have previously received ASCT. Patients must have received prior ASCT at least 12 weeks (3 months) before the first dose of SGN-35 and completed any prior treatment with radiation, chemotherapy, biologics, immunotherapy and/or other investigational agents at least 4 weeks prior to the first dose of SGN-35. 2. Histologically-confirmed CD30-positive disease; tissue from the most recent post-diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block. If such tissue is not available, a fresh biopsy must be obtained. See Section 7.4 for details. 3. Age greater than or equal to 18 years. - Patients of age greater than or equal to 12 years may be enrolled at US sites. 4. Fluorodeoxyglucose (FDG)-avid and measurable disease of at least 1.5 cm as documented by both PET and spiral CT. See Section 7.1 for details. 5. An Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. 6. The following required baseline laboratory data: absolute neutrophil count (ANC) ≥1000/μL, platelets ≥50,000/μL, bilirubin ≤1.5X upper limit of normal (ULN) or ≤3X ULN for patients with Gilberts disease, serum creatinine ≤1.5X ULN, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5X ULN. 7. 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 SGN-35. Females of non-childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. 8. 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. 9. Patients or their legally authorized representative must provide written informed consent. |
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E.4 | Principal exclusion criteria |
1. Previous treatment with SGN-35. 2. Previously received an allogeneic transplant. 3. Congestive heart failure, Class III or IV, by the NYHA criteria. 4. 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, curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamous intraepithelial lesion on PAP smear.) 5. Known cerebral/meningeal disease. 6. Any active viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 2 weeks prior to the first dose of SGN-35. 7. Current therapy with other systemic anti-neoplastic or investigational agents. 8. Therapy with corticosteroids at greater than or equal to 20 mg/day prednisone equivalent within 1 week prior to the first dose of SGN-35. 9. Women who are pregnant or lactating. 10. Patients with a known hypersensitivity to any excipient contained in the drug formulation. 11. Patients with dementia or an altered mental state that would preclude the understanding and rendering of informed consent. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of this study is the overall objective response rate (ORR) per an independent review facility (IRF). |
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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 | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
E.6.13.1 | Other scope of the trial description |
Valutazione della correlazione di potenziali biomarker con gli esiti clinici |
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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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 14 |
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 | Yes |
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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La fine dello studio coincidera` con la chiusura del database finale, 60 mesi dopo l`ultima somministrazione di farmaco all`ultimo paziente. I pazienti saranno seguiti per i dati di sopravvivenza a lungo termine per determinare gli endpoint secondari |
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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 | 5 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 5 |
E.8.9.2 | In all countries concerned by the trial months | 0 |