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

NCT01789723 | Withdrawn Phase 1

• 1 other identifier: SPI-FUS-12-102
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non Hodgkin's Lymphoma

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 8 weeks

Secondary Outcomes (2)

• Impact of Fusilev on Folotyn related Oral Mucositis

  7 weeks

• Relationship between Fusilev use and oral mucositis

  7 weeks

Other Outcomes (1)

• Overall Response Rate (ORR)

  Up to 24 months

Study Arms (5)

Cohort 1: Fusilev - 10 doses

EXPERIMENTAL

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; Drug: Folotyn

Cohort 2: Fusilev - 6 doses

EXPERIMENTAL

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; Drug: Folotyn

Cohort 3: Fusilev - 4 doses

EXPERIMENTAL

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; Drug: Folotyn

Cohort 4: Fusilev - 2 doses

EXPERIMENTAL

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

Drug: Fusilev; Drug: Folotyn

Cohort 5: Fusilev - 1 dose

EXPERIMENTAL

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

Drug: Fusilev; Drug: Folotyn

Interventions

Fusilev DRUG

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.

Also known as: Fusilev - (Levoleucovorin)

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

Folotyn DRUG

A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.

Also known as: Folotyn - (Pralatrexate)

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

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Acrotech Biopharma Inc.: lead

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin

Interventions

Levoleucovorin; 10-propargyl-10-deazaaminopterin

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Leucovorin; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Ahmed Sawas, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2013
• First Posted: February 12, 2013
• Study Start: March 1, 2013
• Primary Completion: March 1, 2015
• Study Completion: March 1, 2015
• Last Updated: January 23, 2020

Record last verified: 2020-01