E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients at high risk of residual Hodgkin lymphoma (HL) following autologous stem cell transplant (ASCT) |
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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 compare the progression-free survival (PFS) of SGN-35 and best supportive care (BSC) versus placebo and BSC |
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E.2.2 | Secondary objectives of the trial |
To compare overall survival (OS) between the 2 treatment arms. To evaluate the safety and tolerability of SGN-35 compared to placebo. To characterize the incidence of anti-therapeutic antibodies (ATA) |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients with HL who have received ASCT in the previous 30�45 days. 2.Patients at high risk of residual HL post ASCT as indicated by at least one of the following: � History of refractory HL (defined as patients progressing on or failing to achieve a complete remission following frontline standard chemotherapy (6 to 8 cycles) or a combined modality treatment program) � Relapsed or progressive HL that occurs <12 months from the end of frontline standard chemotherapy or a combined modality treatment program � Extranodal involvement at time of pre-ASCT relapse (including extranodal extension of nodal masses into adjacent vital organs) 3.Histologically-confirmed HL. 4.Age greater than or equal to 18 years. 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 (unsupported), bilirubin ≤1.5X upper limit of normal (ULN) or ≤3X ULN for patients with Gilbert�s 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.Patients who were determined to have a best clinical response of progressive disease with salvage treatment immediately prior to ASCT. 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, fully excised melanoma in situ [Stage 0], curatively treated localized prostate cancer, and cervical carcinoma in situ on biopsy or a squamou sintraepithelial lesion on PAP smear.) 5.Known cerebral/meningeal disease. 6.Any active systemic viral, bacterial, or fungal infection requiring treatment with antimicrobial therapy within 1 week prior to first study dose. 7.Post ASCT or current therapy with other systemic anti-neoplastic or investigational agents. 8.Women who are pregnant or lactating. 9.Patients with a known hypersensitivity to any excipient contained in the drug formulation. 10.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 efficacy endpoint of this study is progression-free survival (PFS) 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 | 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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
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) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
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 | 2 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 35 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
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 | 6 |
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 |