JRCT ID: jRCT2080221610
Registered date:07/10/2011
Basic Information
Recruitment status | |
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Health condition(s) or Problem(s) studied | relapsed/refractory CD30-positive HL or sALCL |
Date of first enrollment | 07/10/2011 |
Target sample size | 17 |
Countries of recruitment | |
Study type | Interventional |
Intervention(s) | investigational material(s) Generic name etc : SGN-35 INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : Intravenous |
Outcome(s)
Primary Outcome | |
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Secondary Outcome |
Key inclusion & exclusion criteria
Age minimum | >= 20age old |
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Age maximum | Not applicable |
Gender | Both |
Include criteria | Major inclusion criteria include the following: 1) CD30-positive HL or sALCL 2) Patients who had PD during the standard chemo therapy OR who did not have CR/PR OR who had a recurrence or reprogression after the standard chemo therapy 3) Patients with HL must have been ineligible for, refused treatment by or previously received ASCT 4) Eastern Cooperative Oncology Group (ECOG) Performance Status: 0 or 1 5) Adequate hematologic, renal and liver function |
Exclude criteria | Major exclusion criteria include the following: 1) Primary cutaneous ALCL 2) Uncontrolled diabetes 3) Patients with known cerebral/meningeal disease 4) Patients with history of allogeneic stem cell transplant 5) Patients with a history of another malignancy |
Related Information
Primary Sponsor | Takeda Pharmaceutical Company Limited |
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Secondary Sponsor | |
Source(s) of Monetary Support | |
Secondary ID(s) | JapicCTI-111650 |
Contact
Public contact | |
Name | |
Address | https://www.takeda.co.jp/contact/form/jp/form/ |
Telephone | |
Affiliation | Takeda Pharmaceutical Company Limited |
Scientific contact | |
Name | |
Address | https://www.takeda.co.jp/contact/form/jp/form/ |
Telephone | |
Affiliation | Takeda Pharmaceutical Company Limited |