EUCTR2016-001396-69-ESActive, not recruitingPhase 1
An Open Label Phase II Study of Tipifarnib in Subjects with Relapsed or Refractory Peripheral T-Cell LymphomaLymphoma
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Kura Oncology Inc.,
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subject has a diagnosis of PTCL according to the most recent edition of the World Health Organization (WHO) Classification of Tumors of Hematopoietic or Lymphoid Tissues as follows:
- •a. Anaplastic large cell lymphoma (ALCL), ALK positive
- •b. ALCL, ALK negative
- •c. Angioimmunoblastic T-cell lymphoma (AITL)
- •d. Enteropathy-associated T-cell lymphoma
- •e. Extranodal natural killer (NK) T-cell lymphoma, nasal type
- •f. Hepatosplenic T-cell lymphoma
- •g. Peripheral T-cell lymphoma, no otherwise specified (NOS)
- •h. Subcutaneous panniculitis-like T-cell lymphoma
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 25
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
Exclusion Criteria
- •1. Diagnosis of any of the following:
- •a. Precursor T-cell lymphoma or leukemia b. Adult T-cell lymphoma/leukemia (ATLL)
- •c. T-cell prolymphocytic leukemia
- •d. T-cell large granular lymphocytic leukemia
- •e. Primary cutaneous type anaplastic large cell lymphoma
- •Page 6 of 58
- •f. Mycosis fungoide/Sezary syndrome
Investigators
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