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

Acrotech Biopharma logo

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Withdrawn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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems