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

Browse trials for

• Mycoses 539
• Lymphoma 5,578
• Lymphoma, T-Cell 718
• Lymphoma, T-Cell, Peripheral 604
• Mycosis Fungoides 250
• Sezary Syndrome 164

Keywords

• Relapsed
• Refractory

Mycoses

539 studies on the registry are indexed under Mycoses; 55 are open to participants now.

This study's enrollment of 34 is below the median of 46 across 358 interventional studies indexed under Mycoses.

Lead sponsor

Acrotech Biopharma Inc. is the lead sponsor of 27 studies on the registry; 2 are open to participants now.

Study arms

• Experimental
  Bexarotene (Targretin) & Pralatrexate (Folotyn)

  Bexarotene (Targretin): administered po qd. The initial daily dose of bexarotene will depend on the cohort to which each patient is assigned. Bexarotene will be self-administered except in patients who underwent plasma PK sampling on cycle 1, dose 1 and cycle 1, dose 3, at which time bexarotene was to be administered at the investigational site 1 hour (± 5 minutes) prior to pralatrexate administration. Pralatrexate (Folotyn): administered weekly via IV push over a minimum of 30 seconds up to a maximum of 5 minutes. One cycle is 4 weeks in duration consisting of weekly dosing of pralatrexate for 3 weeks followed by 1 week of rest. The initial dose of pralatrexate will depend on the cohort to which each patient is assigned.

  Drug: Pralatrexate Injection · Drug: Bexarotene Capsules · Dietary Supplement: Vitamin B12 · Dietary Supplement: Folic Acid

Interventions

• DrugPralatrexate 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.

  Also known as: FOLOTYN, PDX, Pralatrexate, (RS)-10-propargyl-10-deazaaminopterin

• DrugBexarotene 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.

  Also known as: Bexarotene, Targretin®

• Dietary supplementVitamin 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).

  Also known as: Cyanocobalamin

• Dietary supplementFolic 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).

  Also known as: Vitamin B9, Folate, Folacin

Primary outcomes

1. Dose Limiting Toxicity (DLT) Rate

   DLT rate is the number of patients experiencing a DLT divided by number of evaluable patients and it will be summarized by dose level.

   Time frame: Assessed weekly through cycle 1 (weeks 1-4)

Secondary outcomes

1. Overall Response Rate (ORR)

   best overall response is the best response recorded from the start of treatment until PD. The objective response rate is the proportion of patients with a best overall response of either CR or PR and it will be summarized by dose level and overall.

   Time frame: Assessed after every 2 cycles (8 weeks) for the first 12 months, then every 4 cycles (16 weeks) until progression of disease.

2. Number of Patients with Treatment-related Adverse Events (AEs) and Serious AEs (SAEs)

   (CTCAE) Scale, Version 4.0 for AE grading. * Grade 3 neutropenia lasting for ≥ 7 days or granulocyte colony-stimulating factor (G-CSF) administered. * Grade 3 thrombocytopenia. * Grade 3 treatment-related hyperlipidemia or hypothyroidism * Grade 3 study treatment-related non-hematologic toxicity

   Time frame: Recorded at all study visits: weekly (every 7 +/- 2 days) while on treatment and at safety follow-up (35 +/- 5 days post-last dose) or early termination visit (at time of withdrawal).

3. Pharmacokinetic Parameters

   This was collected during the dose-finding stage of the study. PK sampling is not included in the cohort expansion.

   Time frame: Sampling through 24 hours post end-injection of pralatrexate in cycle 1 dose 1 (week 1) and cycle 1 dose 3 (week 3).