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

Acrotech Biopharma

Status and phase: Withdrawn; Phase 1

Conditions: Non Hodgkin's Lymphoma

Treatments: Drug: Folotyn; Drug: Fusilev

Study type: Interventional

Funder types: Industry

Identifiers

NCT01789723

SPI-FUS-12-102

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

0 participants in 5 patient groups

Cohort 1: Fusilev - 10 doses

Experimental group

Description:

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

Treatment:

Drug: Fusilev

Drug: Folotyn

Cohort 2: Fusilev - 6 doses

Experimental group

Description:

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

Treatment:

Drug: Fusilev

Drug: Folotyn

Cohort 3: Fusilev - 4 doses

Experimental group

Description:

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

Treatment:

Drug: Fusilev

Drug: Folotyn

Cohort 4: Fusilev - 2 doses

Experimental group

Description:

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

Treatment:

Drug: Fusilev

Drug: Folotyn

Cohort 5: Fusilev - 1 dose

Experimental group

Description:

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

Treatment:

Drug: Fusilev

Drug: Folotyn