A Phase 2, Single-Arm, Open-Label, Multicenter, Study of Folotyn® (Pralatrexate Injection) in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With Hematological Malignancies Including PTCL and CTCL

NCT02106650 Phase 2 COMPLETED

This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.

Details

Lead sponsor	Acrotech Biopharma Inc.
Phase	Phase 2
Status	COMPLETED
Enrolment	36
Start date	2014-07
Completion	2019-06

Conditions

• Relapsed Peripheral T-Cell Lymphoma
• Refractory Peripheral T-Cell Lymphoma

Interventions

• Folotyn and Leucovorin
• Folic Acid
• Vitamin B12

Primary outcomes

• Grade 2 Oral Mucositis Prevention — 15 weeks
  To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.

Countries

United States