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)
18 Years
N/A
Both
Non Hodgkin's Lymphoma
Trial Information
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)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Optimal dose and schedule of Fusilev to prevent or reduce mucositis
Outcome 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.
Outcome Time Frame:
Up to 8 weeks
Safety Issue:
Yes
Principal Investigator
Ahmed Sawas, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Columbia University
Authority:
United States: Food and Drug Administration
Study ID:
SPI-FUS-12-102
NCT ID:
NCT01789723
Start Date:
March 2013
Completion Date:
March 2015
Related Keywords:
- Non Hodgkin's Lymphoma
- Lymphoma
- Lymphoma, Non-Hodgkin
- Mucositis
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