This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
This is a Phase 2, single-arm, open-label, multicenter study to determine the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis in patients with hematological malignancies including PTCL and CTCL. Patients with hematological malignancies, including PTCL and CTCL, will be enrolled based on meeting all protocol eligibility criteria. The primary endpoint will be evaluated in the first 7-week treatment cycle. For patients who respond to study treatment, the Investigator can treat patients for a total of 6 cycles. Approximately 37 patients will be enrolled. Safety, as assessed by reported SAEs, will continue to be monitored during the optional treatment period. Efficacy will be followed to the extent that it is evaluated according to the Institution's standard of care. No formal analysis of efficacy will be made.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
36
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.
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.
City of Hope
Duarte, California, United States
Cancer Center of Kansas
Wichita, Kansas, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
Grade 2 Oral Mucositis Prevention
To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
Time frame: 15 weeks
Grade 3 Oral Mucositis Prevention
To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 3 or higher oral mucositis.
Time frame: 15 weeks
Grade 2 Oral Mucositis Duration of first occurrence
To evaluate the time to first occurrence of Folotyn-related Grade 2 or higher oral mucositis.
Time frame: 15 weeks
Grade 2 Oral Mucositis Duration
To evaluate the duration of Folotyn-related Grade 2 or higher oral mucositis.
Time frame: 15 weeks
Effectiveness of Leucovorin in Folotyn dose modification
To evaluate the effect of leucovorin on the number and proportion of patients whose subsequent dose of Folotyn is omitted, delayed, or reduced due to the onset of oral mucositis.
Time frame: 15 weeks
Objective Response Rate
To evaluate objective response rate (ORR) of Folotyn in patients with relapsed or refractory (R/R) PTCL.
Time frame: 17 weeks
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