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

January 21, 2020 updated by: Acrotech Biopharma Inc.

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / 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.

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort 1: Fusilev - 10 doses

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
Drug: Fusilev
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.
Other Names:
  • Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Names:
  • Folotyn - (Pralatrexate)
Experimental: Cohort 2: Fusilev - 6 doses

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
Drug: Fusilev
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.
Other Names:
  • Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Names:
  • Folotyn - (Pralatrexate)
Experimental: Cohort 3: Fusilev - 4 doses

5 mg/m2 BID, on Days 2 (24 ± 3 hours after Folotyn dose) and 3.

Folotyn: 30 mg/m2 once weekly for 6 weeks
Drug: Fusilev
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.
Other Names:
  • Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Names:
  • Folotyn - (Pralatrexate)
Experimental: Cohort 4: Fusilev - 2 doses

5 mg/m2 BID, on Day 2 (24 ± 3 hours after Folotyn dose.

Folotyn: 30 mg/m2 once weekly for 6 weeks
Drug: Fusilev
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.
Other Names:
  • Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Names:
  • Folotyn - (Pralatrexate)
Experimental: Cohort 5: Fusilev - 1 dose

Fusilev: 5 mg/m2 once on Day 2.

Folotyn: 30 mg/m2 once weekly for 6 weeks
Drug: Fusilev
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.
Other Names:
  • Fusilev - (Levoleucovorin)
Drug: Folotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Other Names:
  • Folotyn - (Pralatrexate)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal dose and schedule of Fusilev to prevent or reduce mucositis
Time Frame: Up to 8 weeks
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.
Up to 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of Fusilev on Folotyn related Oral Mucositis
Time Frame: 7 weeks
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
7 weeks
Relationship between Fusilev use and oral mucositis
Time Frame: 7 weeks
To determine the relationship between Fusilev use and oral mucositis as a function of the pretreatment homocysteine (HCY) and methylmalonic acid (MMA) levels
7 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Response Rate (ORR)
Time Frame: Up to 24 months
To determine overall response rate (ORR) of Folotyn in relapsed or refractory Non-Hodgkin's lymphoma other than PTCL
Up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acrotech Biopharma Inc.

Investigators

  • Principal Investigator: Ahmed Sawas, MD, Columbia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2013

Primary Completion (Anticipated)

March 1, 2015

Study Completion (Anticipated)

March 1, 2015

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 8, 2013

First Posted (Estimate)

February 12, 2013

Study Record Updates

Last Update Posted (Actual)

January 23, 2020

Last Update Submitted That Met QC Criteria

January 21, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPI-FUS-12-102

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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