Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies

PHASE2CompletedINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

July 31, 2014

Primary Completion Date

October 31, 2018

Study Completion Date

June 30, 2019

Conditions
Relapsed Peripheral T-Cell LymphomaRefractory Peripheral T-Cell Lymphoma
Interventions
DRUG

Folotyn and Leucovorin

DRUG

Folic Acid

Folic acid (1.0 mg PO QD) is to be initiated at least 10 days prior to Folotyn administration, or per the USPI for Folotyn.

DRUG

Vitamin B12

Vitamin B12 (1 mg IM) is to be administered within 10 weeks prior to initiation of Folotyn and can be administered during Screening. Subsequent vitamin B12 injections may be given the same day as treatment with Folotyn and patients are to receive vitamin B12 every 8 to 10 weeks while treated with Folotyn.

Trial Locations (3)

67214

Cancer Center of Kansas, Wichita

91010

City of Hope, Duarte

98109

Seattle Cancer Care Alliance, Seattle

Sponsors
All Listed Sponsors
collaborator

Axis Clinicals Limited

INDUSTRY

lead

Acrotech Biopharma Inc.

INDUSTRY