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Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma
Trial ID: NCT01134341
This study is designed to determine the recommended dose, safety, pharmacokinetics, and early efficacy of the combination of pralatrexate plus oral bexarotene in patients with relapsed or refractory CTCL.
A Phase 1, Open-label, Dose-finding Study of Pralatrexate Plus Systemic Bexarotene in Patients With Relapsed or Refractory Cutaneous T Cell Lymphoma
- Cutaneous T-cell lymphoma patients with subtypes of mycosis fungoides (MF) Stage IB or
higher, Sézary syndrome, or primary cutaneous anaplastic large cell lymphoma who have
failed a previous systemic treatment.
- Patients must have received at least 1 previous systemic therapy, and either
progressed or not tolerated their last prior treatment regimen.
- Eastern Cooperative Oncology Group Performance Status less than or equal to 2.
- Adequate blood, liver, and kidney function as defined by laboratory tests.
- Women of childbearing potential must practice medically acceptable contraception from
study treatment start until at least 30 days after the last dose of study treatment.
Negative serum pregnancy test within 14 days before the first day of study treatment
(not required for patients who are postmenopausal for at least 1 year or surgically
sterilized). Study treatment should not be given to women who are breastfeeding.
- Males who are sexually active must agree to practice medically acceptable barrier
contraception while receiving study treatment and for 30 days after the last dose of
- Give written informed consent & privacy authorization.
- If there is a history of prior malignancies other than non-melanoma skin cancer,
carcinoma in situ of the cervix, localized prostate cancer, or localized thyroid
cancer, patient must be disease free for at least 5 years. Patients with other prior
malignancies less than 5 years before study entry may be enrolled if they received
treatment resulting in complete resolution of the cancer and have no current clinical,
radiologic, or laboratory evidence of active or recurrent disease.
- Human immunodeficiency virus (HIV)-positive diagnosis with a CD4 count of less than
100 mm3 or detectable viral load within the past 3 months, and receiving combination
- Diagnosis of Hepatitis B virus, or Hepatitis C virus with detectable viral load or
immunological evidence of chronic active disease or receiving/requiring antiviral
- Active central nervous system disease requiring treatment.
- Active uncontrolled infection, underlying medical condition, or other serious illness
impairing the patient's ability to receive protocol treatment.
- Discontinuation of prior oral bexarotene due to an allergic reaction or
- Major surgery within 2 weeks of planned start of treatment.
- Conventional or investigational chemotherapy or radiation therapy encompassing greater
than 10% of bone marrow within 4 weeks prior to study treatment.
- ECP, phototherapy with PUVA, or ultraviolet (UV) therapy within 2 weeks prior to study
- Systemic corticosteroids within 3 weeks of study treatment, unless patient has been
taking a continuous dose of no more than 10 mg per day of prednisone or equivalent for
at least 4 weeks.
- Initiation of or change in dosage of topical corticosteroids within 3 weeks of study
treatment (topical steroid use within 3 weeks is allowed provided the strength and use
has been stable for at least 4 weeks).
- Investigational drugs, biologics, or devices use within 2 weeks prior to study
treatment or planned use during the study.
- Monoclonal antibody within 3 months without evidence of PD.
- Use of oral retinoids, except bexarotene, within 4 weeks of study treatment or
high-dose vitamin A (once daily multi-vitamin allowed).
- Previous exposure to pralatrexate.
- Uncontrolled hypercholesterolemia or hypertriglyceridemia.
drug: Pralatrexate Injection
drug: Bexarotene Capsules
dietary supplement: Folic Acid
dietary supplement: Vitamin B12
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