Trial Search Results
Study of Tipifarnib in Subjects With Relapsed or Refractory Peripheral T-Cell Lymphoma
The purpose of this study is to test the efficacy of an investigational drug, Tipifarnib, in participants previously diagnosed with relapsed or refractory peripheral T-Cell lymphoma across the United States.
Stanford is currently accepting patients for this trial.
Kura Oncology, Inc.
- Drug: Tipifarnib
- Diagnosis of PTCL according to the most recent edition of the World Health
Organization (WHO) Classification of Tumors of Hematopoietic or Lymphoid Tissues, as
1. Anaplastic large cell lymphoma (ALCL), ALK positive
2. ALCL, ALK negative
3. Angioimmunoblastic T-cell lymphoma (AITL)
4. Enteropathy-associated T-cell lymphoma
5. Extranodal natural killer (NK) T-cell lymphoma, nasal type
6. Hepatosplenic T-cell lymphoma
7. Peripheral T-cell lymphoma, no otherwise specified (NOS)
8. Subcutaneous panniculitis-like T-cell lymphoma For enrollment into the AITL
expansion cohort, subjects must have he diagnosis of AITL.
- Relapsed or are refractory to at least 1 prior systemic cytotoxic therapy. -Subjects
must have received conventional therapy as a prior therapy.
- ECOG performance status of 0-2
- Acceptable liver and renal function
- Acceptable hematologic status
- Female subjects must be either:
1. Of non-child-bearing potential (surgically sterilized or at least 2 years
2. If of child-bearing potential, subject must use an adequate method of
contraception consisting of two-barrier method or one barrier method with a
spermicide or intrauterine device. Both females and male subjects with female
partners of child-bearing potential must agree to use an adequate method of
contraception for 2 weeks prior to screening, during, and at least 4 weeks after
last dose of trial medication. Female subjects must have a negative serum or
urine pregnancy test within 72 hours prior to start of trial medication.
3. Not breast feeding at any time during the study.
- Written and voluntary informed consent.
- Diagnosis of any of the following:
1. Precursor T-cell lymphoma or leukemia
2. Adult T-cell lymphoma/leukemia (ATLL)
3. T-cell prolymphocytic leukemia
4. T-cell large granular lymphocytic leukemia
5. Primary cutaneous type anaplastic large cell lymphoma
6. Mycosis fungoide/Sezary syndrome
- Ongoing treatment with an anticancer agent not contemplated in this protocol.
- Any history of clinically relevant coronary artery disease or myocardial infarction
within the last 3 years.
- Known central nervous system lymphoma.
- Stem cell transplant less than 3 months prior to enrolment.
- Non-tolerable > Grade 2 neuropathy or evidence of unstable neurological symptoms
within 4 weeks of Cycle 1 Day 1.
- Major surgery, other than diagnostic surgery, within 2 weeks prior to Cycle 1 Day 1,
without complete recovery.
- Other active malignancy requiring therapy such as radiation, chemotherapy, or
- Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic
therapy. Known infection with HIV, or an active infection with hepatitis B or
Ages Eligible for Study
18 Years - N/A
Genders Eligible for Study