Pralatrexate and Bexarotene in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

PHASE1CompletedINTERVENTIONAL
Enrollment

34

Participants

Timeline

Start Date

March 31, 2010

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Cutaneous T-cell LymphomaMycosis FungoidesSezary SyndromePrimary Cutaneous Anaplastic Large Cell Lymphoma
Interventions
DRUG

Pralatrexate Injection

"Intravenous (IV) push over 30 seconds to 5 minutes via a patent free-flowing IV line containing normal saline (0.9% sodium chloride).~10 or 15 mg/m2, depending on cohort assignment.~Dose reductions allowed for protocol-specified criteria.~Administered weekly for 3 weeks of 4-week cycle (weekly for 3 weeks with one week of rest) until criteria for discontinuation per the protocol are met."

DRUG

Bexarotene Capsules

"150 or 300 mg orally, depending on cohort assignment. Provided as 75 mg capsules and taken with a meal.~Dose reductions allowed for protocol-specified criteria and implemented per the Targretin® package insert.~Administered daily until criteria for study treatment discontinuation per the protocol are met."

DIETARY_SUPPLEMENT

Vitamin B12

"1 mg intramuscular injection~Administered within 10 weeks prior to start of study treatment, every 8-10 weeks throughout the study and for 30 days after last study treatment (dose of pralatrexate or bexarotene)."

DIETARY_SUPPLEMENT

Folic Acid

"1-1.25 mg orally~Administered daily for at least 7 days prior to start of study treatment, throughout the study and for 30 days after last study treatment (dose of pralatrexate or bexarotene)."

Trial Locations (5)

10021

Memorial Sloan-Kettering Cancer Center, New York

15213

University of Pittsburgh School of Medicine, Pittsburgh

40138

Ospedale Sant'Orsola - Policlinico Sant'Orsola, Bologna

77030

MD Anderson Cancer Center, Houston

94305

Stanford University School of Medicine, Stanford

Sponsors
All Listed Sponsors
lead

Acrotech Biopharma Inc.

INDUSTRY