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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

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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221610
Enrollment
17
Registered
2011-10-07
Start date
2011-10-07
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

relapsed/refractory CD30-positive HL or sALCL

Interventions

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 :

Sponsors

Takeda Pharmaceutical Company Limited
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026