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

NCT02106650 | Completed Phase 2

• 1 other identifier: SPI-FOL-14-201
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

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

Keywords

Relapsed PTCL; Refractory PTCL

Outcome Measures

Primary Outcomes (1)

• Grade 2 Oral Mucositis Prevention

  To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.

  15 weeks

Secondary Outcomes (5)

• Grade 3 Oral Mucositis Prevention

  15 weeks

• Grade 2 Oral Mucositis Duration of first occurrence

  15 weeks

• Grade 2 Oral Mucositis Duration

  15 weeks

• Effectiveness of Leucovorin in Folotyn dose modification

  15 weeks

• Objective Response Rate

  17 weeks

Study Arms (1)

Folotyn and Leucovorin

EXPERIMENTAL

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; Drug: Folic Acid; Drug: Vitamin B12

Interventions

Folotyn and Leucovorin DRUG

Also known as: Pralatrexate (Folotyn)

Folotyn and Leucovorin

Folic Acid DRUG

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.

Folotyn and Leucovorin

Vitamin B12 DRUG

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.

Folotyn and Leucovorin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is diagnosed with hematological malignancies including PTCL and CTCL and are eligible for treatment with a dose of 30 mg/m\^2
• Patient is at least 18 years of age
• Patient has been informed of the investigational nature of this study and has given written Informed Consent and is able to adhere to dosing and visit schedules and meet all study requirements
• Patient has recovered from the toxic effects of prior therapy, and is at least 30 days from the most recent cytotoxic therapy, prior to enrollment
• Patient has adequate hematologic, hepatic, and renal function as defined by:
• ANC ≥1000/µL
• Platelet count ≥100,000/µL
• Total bilirubin ≤1.5 mg/dL
• Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT), and gamma-glutamyltransferase (GGT) ≤2.5 xupper limit of normal (ULN) (AST/ALT/GGT ≤5 xULN if documented hepatic involvement with lymphoma)
• Creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥50 mL/min
• Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
• Females of childbearing potential are to agree to practice a medically acceptable contraceptive regimen (including a barrier method) from study treatment initiation until at least 30 days after the last administration of Folotyn or leucovorin, whichever is last, and are to have a negative urine beta human chorionic gonadotropin (β-HCG) pregnancy test within 14 days prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as \>12 months since last menses) or are surgically sterilized do not require this test
• Male patients are to agree to use a barrier method of contraception from study treatment initiation until at least 90 days after the last administration of Folotyn

You may not qualify if:

• Patient has congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification
• Patient has uncontrolled hypertension
• Patient has known, uncontrolled human immunodeficiency virus (HIV)-positive diagnosis
• Patient has symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
• Patient has an active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
• Patient has had major surgery within 14 days prior to enrollment
• Patient has used any investigational drugs, biologics, or devices within 14 days prior to study treatment or plans to use any of these during the course of the study
• Patient has had previous exposure to Folotyn within 6 months of study enrollment
• Patient is pregnant or breast-feeding

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead
• Axis Clinicals Limited: collaborator

Study Sites (3)

City of Hope

Duarte, California, 91010, United States

Location

Cancer Center of Kansas

Wichita, Kansas, 67214, United States

Location

Seattle Cancer Care Alliance

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Iyer SP, Dakhil S, Shinohara MM, Zain J, Acosta M, Foss F. Pralatrexate injection combined with oral leucovorin for mucositis management in PTCL/CTCL treatment: a multicenter phase 2 trial. Blood Neoplasia. 2024 Nov 2;2(1):100055. doi: 10.1016/j.bneo.2024.100055. eCollection 2025 Feb.

  PMID: 40546726 DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

10-propargyl-10-deazaaminopterin; Leucovorin; Folic Acid; Vitamin B 12

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Formyltetrahydrofolates; Tetrahydrofolates; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Corrinoids; Tetrapyrroles; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds, 4 or More Rings; Macrocyclic Compounds; Polycyclic Compounds

Study Officials

• Wasim Khan, MD

  Acrotech Biopharma Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2014
• First Posted: April 8, 2014
• Study Start: July 1, 2014
• Primary Completion: October 1, 2018
• Study Completion: June 1, 2019
• Last Updated: November 20, 2019

Record last verified: 2019-11

Locations

US (3)