Non Hodgkin's Lymphoma
Conditions
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.
Interventions
DRUGFusilev
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.
DRUGFolotyn
A cycle of Folotyn treatment is 7 weeks, 6 weeks of treatment followed by 1 week of rest.
Sponsors
Acrotech Biopharma Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Optimal dose and schedule of Fusilev to prevent or reduce mucositis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Impact of Fusilev on Folotyn related Oral Mucositis | 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 |
| Relationship between Fusilev use and oral mucositis | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | Up to 24 months | To determine overall response rate (ORR) of Folotyn in relapsed or refractory Non-Hodgkin's lymphoma other than PTCL |
Outcome results
None listed