Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02106650|
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : November 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Relapsed Peripheral T-Cell Lymphoma Refractory Peripheral T-Cell Lymphoma||Drug: Folotyn and Leucovorin Drug: Folic Acid Drug: Vitamin B12||Phase 2|
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 (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 2014|
|Actual Primary Completion Date :||October 2018|
|Actual Study Completion Date :||June 2019|
Experimental: Folotyn and Leucovorin
Folotyn will be administered by IV push at a dose of 30 mg/m2 once weekly for 6 weeks in each cycle, followed by 1 week of rest (no treatment).
Leucovorin (25 mg tablets) will be taken orally tid for 2 days for a total of six doses (150 mg cumulative weekly dose), beginning 24 hours after each dose of Folotyn is administered.
Folic acid and Vitamin B12 is given prior to initiation of Folotyn.
Drug: Folotyn and Leucovorin
Other Name: Pralatrexate (Folotyn)
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.
- Grade 2 Oral Mucositis Prevention [ Time Frame: 15 weeks ]To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
- Grade 3 Oral Mucositis Prevention [ Time Frame: 15 weeks ]To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 3 or higher oral mucositis.
- Grade 2 Oral Mucositis Duration of first occurrence [ Time Frame: 15 weeks ]To evaluate the time to first occurrence of Folotyn-related Grade 2 or higher oral mucositis.
- Grade 2 Oral Mucositis Duration [ Time Frame: 15 weeks ]To evaluate the duration of Folotyn-related Grade 2 or higher oral mucositis.
- Effectiveness of Leucovorin in Folotyn dose modification [ Time Frame: 15 weeks ]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.
- Objective Response Rate [ Time Frame: 17 weeks ]To evaluate objective response rate (ORR) of Folotyn in patients with relapsed or refractory (R/R) PTCL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02106650
|United States, California|
|City of Hope|
|Duarte, California, United States, 91010|
|United States, Kansas|
|Cancer Center of Kansas|
|Wichita, Kansas, United States, 67214|
|United States, Washington|
|Seattle Cancer Care Alliance|
|Seattle, Washington, United States, 98109|
|Study Director:||Wasim Khan, MD||Acrotech Biopharma LLC|