Cutaneous T-cell Lymphoma Clinical Trial
Official title:
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
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.
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).
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