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

Non Hodgkin's Lymphoma Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01789723
• Other study ID #: SPI-FUS-12-102
• Status: Withdrawn
• Phase: Phase 1
• Start date: March 2013
• Est. completion date: March 2015

Study information

• Verified date: January 2020
• Source: Acrotech Biopharma LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin
• Mucositis
• Non Hodgkin's Lymphoma

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Acrotech Biopharma LLC

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall Response Rate (ORR)	To determine overall response rate (ORR) of Folotyn in relapsed or refractory Non-Hodgkin's lymphoma other than PTCL	Up to 24 months
Primary	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	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	7 weeks
Secondary	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	7 weeks