A Phase 1/2, Single-arm, Open-label Study of SGN-35 in Japanese Patients with relapsed/refractory CD30-positive Hodgkin Lymphoma or Systemic Anaplastic Large Cell Lymphoma

Phase 1

• Conditions: relapsed/refractory CD30-positive HL or sALC

• Registration Number: JPRN-jRCT2080221610
• Lead Sponsor: Takeda Pharmaceutical Company Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-10-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 17

Inclusion 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

Exclusion 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

Study & Design

• Study Type: Interventional
• Study Design: Not specified