NCT00554827

Study of Pralatrexate in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

A Phase 1, Open-label Study of Pralatrexate With Vitamin B12 and Folic Acid Supplementation in Patients With Relapsed or Refractory Cutaneous T-cell Lymphoma

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Acrotech Biopharma Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is being conducted to identify how much and how often pralatrexate, given with vitamin B12 and folic acid, can be given safely to patients with cutaneous T-cell lymphoma (CTCL) that has relapsed (returned after responding to previous treatment) or is refractory (has not responded to previous treatment). It is also being conducted to get information on whether or not pralatrexate is effective in treating relapsed or refractory CTCL.

Detailed description

This is a Phase 1, single-arm, open-label, multi-center study designed to determine an effective and well-tolerated dose and schedule of pralatrexate when administered concurrently with vitamin B12 and folic acid supplementation to patients with relapsed or refractory CTCL. The start of study treatment is defined as the initiation of pralatrexate. A patient may begin pralatrexate, provided he/she has methylmalonic acid (MMA) serum concentrations \< 200 nmol/L and homocysteine (Hcy) concentrations \< 10 μmol/L at screening. If a patient has elevated MMA and/or Hcy concentrations, vitamin supplementation will be initiated at least 10 days prior to pralatrexate initiation. Once the patient is on study, the dosing of vitamin supplementation must adhere to the schedule defined by the protocol. Vitamin supplementation will consist of vitamin BB12 1 mg intramuscular (IM) every (q) 8-10 weeks, and folic acid 1 mg by mouth (PO) once a day (QD).

Conditions

• Cutaneous T-cell Lymphoma

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Vitamin B12	1 mg intramuscular injection Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels. Administered every 8-10 weeks throughout the study and for at least 30 days after last dose of pralatrexate.
DIETARY_SUPPLEMENT	Folic Acid	1 mg orally Administered at least 10 days prior to start of pralatrexate if patient has elevated methylmalonic acid (MMA) and/or homocysteine(Hcy) levels. Administered daily throughout the study and for at least 30 days after last dose of pralatrexate.
DRUG	Pralatrexate	Intravenous (IV) push over 3-5 minutes into a patent IV line containing normal saline (0.9% sodium chloride). Pralatrexate will be administered via intravenous (IV) push over 3-5 minutes. The frequency of pralatrexate will be administered weekly for 3 or

Timeline

• Start date: 2007-08-01
• Primary completion: 2012-01-01
• Completion: 2012-02-01
• First posted: 2007-11-07
• Last updated: 2020-01-03

Locations

10 sites across 1 country: United States