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Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn

Primary Purpose

Non Hodgkin's Lymphoma

Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Fusilev
Folotyn
Sponsored by
Acrotech Biopharma Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non Hodgkin's Lymphoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 18 years of age
  • Patients with relapsed or refractory NHL who are eligible for Folotyn treatment. Patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography [CT]
  • Progressive disease or persistent disease after at least 1 prior treatment
  • ECOG performance status ≤ 2
  • Adequate hematological, hepatic, and renal function

Exclusion Criteria:

  • Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix)
  • Congestive heart failure
  • Uncontrolled hypertension
  • Known human immunodeficiency virus (HIV)-positive diagnosis
  • Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
  • Major surgery within 14 days of enrollment
  • Pregnant or breast-feeding women
  • Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
  • Previous exposure to pralatrexate

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm Type

    Experimental

    Experimental

    Experimental

    Experimental

    Experimental

    Arm Label

    Cohort 1: Fusilev - 10 doses

    Cohort 2: Fusilev - 6 doses

    Cohort 3: Fusilev - 4 doses

    Cohort 4: Fusilev - 2 doses

    Cohort 5: Fusilev - 1 dose

    Arm Description

    Fusilev: 5 mg/m2 QID, starting on Day 2 (24 ± 3 hours after Folotyn dose) for a total of 10 doses Day 2: 4 doses Day 3: 4 doses Day 4: 2 doses. Folotyn: 30 mg/m2 once weekly for 6 weeks

    Fusilev: 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose), 3, and 4. Folotyn: 30 mg/m2 once weekly for 6 weeks

    5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3. Folotyn: 30 mg/m2 once weekly for 6 weeks

    5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose. Folotyn: 30 mg/m2 once weekly for 6 weeks

    Fusilev: 5 mg/m2 once on Day 2. Folotyn: 30 mg/m2 once weekly for 6 weeks

    Outcomes

    Primary Outcome Measures

    Optimal dose and schedule of Fusilev to prevent or reduce mucositis
    The patient will be seen in the clinic for an oral mucositis assessment at baseline. During the 6 weeks of Folotyn treatment, oral mucositis assessment will be performed weekly prior to each Folotyn dose and again on Day 4 (prior to the Fusilev dose when applicable) by a qualified health care professional. Patients will complete an Oral Mucositis Daily Questionnaire (OMQD) starting at Day 1 of Week 1 and ending at the End of Treatment Visit.

    Secondary Outcome Measures

    Impact of Fusilev on Folotyn related Oral Mucositis
    To determine the impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis To determine the impact of Fusilev on the frequency of Folotyn-related oral mucositis To determine the impact of Fusilev on the number of Folotyn doses delivered
    Relationship between Fusilev use and oral mucositis
    To determine the relationship between Fusilev use and oral mucositis as a function of the pretreatment homocysteine (HCY) and methylmalonic acid (MMA) levels

    Full Information

    First Posted
    February 7, 2013
    Last Updated
    January 21, 2020
    Sponsor
    Acrotech Biopharma Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01789723
    Brief Title
    Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn
    Official Title
    An Open Label, Multicenter, Dose Finding, Phase 1 Study of Fusilev® (Levoleucovorin) to Prevent or Reduce Mucositis in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma Receiving Folotyn® (Pralatrexate)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    March 2013 (undefined)
    Primary Completion Date
    March 2015 (Anticipated)
    Study Completion Date
    March 2015 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Acrotech Biopharma Inc.

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is determine the optimal dose and schedule of Fusilev to prevent or reduce Mucositis in patients with Non-Hodgkin's Lymphoma receiving Folotyn treatment.
    Detailed Description
    This is an open label, uncontrolled, nonrandomized, multicenter, dose finding, Phase 1 study primarily to determine the optimal dose and schedule of Fusilev to prevent or reduce Folotyn-related Grade 3 or higher oral Mucositis.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non Hodgkin's Lymphoma

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 1
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Cohort 1: Fusilev - 10 doses
    Arm Type
    Experimental
    Arm Description
    Fusilev: 5 mg/m2 QID, starting on Day 2 (24 ± 3 hours after Folotyn dose) for a total of 10 doses Day 2: 4 doses Day 3: 4 doses Day 4: 2 doses. Folotyn: 30 mg/m2 once weekly for 6 weeks
    Arm Title
    Cohort 2: Fusilev - 6 doses
    Arm Type
    Experimental
    Arm Description
    Fusilev: 5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose), 3, and 4. Folotyn: 30 mg/m2 once weekly for 6 weeks
    Arm Title
    Cohort 3: Fusilev - 4 doses
    Arm Type
    Experimental
    Arm Description
    5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3. Folotyn: 30 mg/m2 once weekly for 6 weeks
    Arm Title
    Cohort 4: Fusilev - 2 doses
    Arm Type
    Experimental
    Arm Description
    5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose. Folotyn: 30 mg/m2 once weekly for 6 weeks
    Arm Title
    Cohort 5: Fusilev - 1 dose
    Arm Type
    Experimental
    Arm Description
    Fusilev: 5 mg/m2 once on Day 2. Folotyn: 30 mg/m2 once weekly for 6 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Fusilev
    Other Intervention Name(s)
    Fusilev - (Levoleucovorin)
    Intervention Description
    Fusilev will be administered by IV push (3-5 minutes) at a dose of 5 mg/m2. Fusilev administration, QID or BID will start 24 ± 3 hours after Folotyn administration depending on the dose cohort.
    Intervention Type
    Drug
    Intervention Name(s)
    Folotyn
    Other Intervention Name(s)
    Folotyn - (Pralatrexate)
    Intervention Description
    A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
    Primary Outcome Measure Information:
    Title
    Optimal dose and schedule of Fusilev to prevent or reduce mucositis
    Description
    The patient will be seen in the clinic for an oral mucositis assessment at baseline. During the 6 weeks of Folotyn treatment, oral mucositis assessment will be performed weekly prior to each Folotyn dose and again on Day 4 (prior to the Fusilev dose when applicable) by a qualified health care professional. Patients will complete an Oral Mucositis Daily Questionnaire (OMQD) starting at Day 1 of Week 1 and ending at the End of Treatment Visit.
    Time Frame
    Up to 8 weeks
    Secondary Outcome Measure Information:
    Title
    Impact of Fusilev on Folotyn related Oral Mucositis
    Description
    To determine the impact of Fusilev on the number of Folotyn-related dose modifications secondary to oral mucositis To determine the impact of Fusilev on the frequency of Folotyn-related oral mucositis To determine the impact of Fusilev on the number of Folotyn doses delivered
    Time Frame
    7 weeks
    Title
    Relationship between Fusilev use and oral mucositis
    Description
    To determine the relationship between Fusilev use and oral mucositis as a function of the pretreatment homocysteine (HCY) and methylmalonic acid (MMA) levels
    Time Frame
    7 weeks
    Other Pre-specified Outcome Measures:
    Title
    Overall Response Rate (ORR)
    Description
    To determine overall response rate (ORR) of Folotyn in relapsed or refractory Non-Hodgkin's lymphoma other than PTCL
    Time Frame
    Up to 24 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: At least 18 years of age Patients with relapsed or refractory NHL who are eligible for Folotyn treatment. Patient has histologically/cytologically confirmed, measurable (lesion or node ≥ 2 cm by computed tomography [CT] Progressive disease or persistent disease after at least 1 prior treatment ECOG performance status ≤ 2 Adequate hematological, hepatic, and renal function Exclusion Criteria: Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix) Congestive heart failure Uncontrolled hypertension Known human immunodeficiency virus (HIV)-positive diagnosis Active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment Major surgery within 14 days of enrollment Pregnant or breast-feeding women Symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible Previous exposure to pralatrexate
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ahmed Sawas, MD
    Organizational Affiliation
    Columbia University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Phase 1 Study of Fusilev to Prevent or Reduce Mucositis in Patients With Non-Hodgkin's Lymphoma Receiving Folotyn

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