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Clinical Trials/JPRN-jRCT2080221610
JPRN-jRCT2080221610UnknownPhase 1

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

Takeda Pharmaceutical Company Limited0 sites17 target enrollmentStarted: October 7, 2011Last updated:
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Conditions

Trial Snapshot

Phase
Phase 1
Enrollment
17
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
>= 20age old to ot applicable (—)
Sex
All

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

Investigators

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