Phase 2, Single Arm, Open Label Study of Folotyn in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With Hematological Malignancies

Recruiting

This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 3 or higher oral mucositis.

Study Type:    Interventional

Study Design:    

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title:   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

Conditions:  

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

Interventions:  

Drug: Folotyn and Leucovorin
Drug: Folic Acid
Drug: Vitamin B12
             

Phase:  Phase 2

External Link:  https://clinicaltrials.gov/ct2/show/NCT02106650