NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2080221610

Registered date:07/10/2011

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedrelapsed/refractory CD30-positive HL or sALCL
Date of first enrollment07/10/2011
Target sample size17
Countries of recruitment
Study typeInterventional
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
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum>= 20age old
Age maximumNot applicable
GenderBoth
Include criteriaMajor 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 criteriaMajor 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

Contact

Public contact
Name
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation Takeda Pharmaceutical Company Limited
Scientific contact
Name
Address https://www.takeda.co.jp/contact/form/jp/form/
Telephone
E-mail
Affiliation Takeda Pharmaceutical Company Limited