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Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies

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ClinicalTrials.gov Identifier: NCT02106650
Recruitment Status : Completed
First Posted : April 8, 2014
Last Update Posted : November 20, 2019
Sponsor:
Collaborator:
Axis Clinicals Limited
Information provided by (Responsible Party):
Acrotech Biopharma LLC

Tracking Information
First Submitted Date  ICMJE March 28, 2014
First Posted Date  ICMJE April 8, 2014
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE July 2014
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
Grade 2 Oral Mucositis Prevention [ Time Frame: 15 weeks ]
To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
Original Primary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
Grade 3 Oral Mucositis Prevention [ Time Frame: 15 weeks ]
To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 3 or higher oral mucositis.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 11, 2014)
  • Grade 3 Oral Mucositis Prevention [ Time Frame: 15 weeks ]
    To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 3 or higher oral mucositis.
  • Grade 2 Oral Mucositis Duration of first occurrence [ Time Frame: 15 weeks ]
    To evaluate the time to first occurrence of Folotyn-related Grade 2 or higher oral mucositis.
  • Grade 2 Oral Mucositis Duration [ Time Frame: 15 weeks ]
    To evaluate the duration of Folotyn-related Grade 2 or higher oral mucositis.
  • Effectiveness of Leucovorin in Folotyn dose modification [ Time Frame: 15 weeks ]
    To evaluate the effect of leucovorin on the number and proportion of patients whose subsequent dose of Folotyn is omitted, delayed, or reduced due to the onset of oral mucositis.
  • Objective Response Rate [ Time Frame: 17 weeks ]
    To evaluate objective response rate (ORR) of Folotyn in patients with relapsed or refractory (R/R) PTCL.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 3, 2014)
  • Grade 2 Oral Mucositis Prevention [ Time Frame: 15 weeks ]
    To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
  • Effectiveness of Leucovorin in Folotyn dose modification [ Time Frame: 15 weeks ]
    To evaluate the effect of leucovorin on the number and proportion of patients whose subsequent dose of Folotyn is omitted, delayed, or reduced due to the onset of oral mucositis.
  • Overall Response Rate [ Time Frame: 17 weeks ]
    To evaluate overall response rate (ORR) of Folotyn in patients with relapsed or refractory (R/R) PTCL.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Phase II Study of Folotyn With Leucovorin to Prevent/Reduce Mucositis in Patients With Hematological Malignancies
Official Title  ICMJE A Phase 2, Single-Arm, Open-Label, Multicenter, Study of Folotyn® (Pralatrexate Injection) in Combination With Oral Leucovorin to Prevent or Reduce Mucositis in Patients With Hematological Malignancies Including PTCL and CTCL
Brief Summary This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.
Detailed Description

This is a Phase 2, single-arm, open-label, multicenter study to determine the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis in patients with hematological malignancies including PTCL and CTCL.

Patients with hematological malignancies, including PTCL and CTCL, will be enrolled based on meeting all protocol eligibility criteria. The primary endpoint will be evaluated in the first 7-week treatment cycle. For patients who respond to study treatment, the Investigator can treat patients for a total of 6 cycles. Approximately 37 patients will be enrolled. Safety, as assessed by reported SAEs, will continue to be monitored during the optional treatment period. Efficacy will be followed to the extent that it is evaluated according to the Institution's standard of care. No formal analysis of efficacy will be made.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Relapsed Peripheral T-Cell Lymphoma
  • Refractory Peripheral T-Cell Lymphoma
Intervention  ICMJE
  • Drug: Folotyn and Leucovorin
    Other Name: Pralatrexate (Folotyn)
  • Drug: Folic Acid
    Folic acid (1.0 mg PO QD) is to be initiated at least 10 days prior to Folotyn administration, or per the USPI for Folotyn.
  • Drug: Vitamin B12
    Vitamin B12 (1 mg IM) is to be administered within 10 weeks prior to initiation of Folotyn and can be administered during Screening. Subsequent vitamin B12 injections may be given the same day as treatment with Folotyn and patients are to receive vitamin B12 every 8 to 10 weeks while treated with Folotyn.
Study Arms  ICMJE Experimental: Folotyn and Leucovorin

Folotyn will be administered by IV push at a dose of 30 mg/m2 once weekly for 6 weeks in each cycle, followed by 1 week of rest (no treatment).

Leucovorin (25 mg tablets) will be taken orally tid for 2 days for a total of six doses (150 mg cumulative weekly dose), beginning 24 hours after each dose of Folotyn is administered.

Folic acid and Vitamin B12 is given prior to initiation of Folotyn.

Interventions:
  • Drug: Folotyn and Leucovorin
  • Drug: Folic Acid
  • Drug: Vitamin B12
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 30, 2019)
36
Original Estimated Enrollment  ICMJE
 (submitted: April 3, 2014)
20
Actual Study Completion Date  ICMJE June 2019
Actual Primary Completion Date October 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patient is diagnosed with hematological malignancies including PTCL and CTCL and are eligible for treatment with a dose of 30 mg/m^2
  2. Patient is at least 18 years of age
  3. Patient has been informed of the investigational nature of this study and has given written Informed Consent and is able to adhere to dosing and visit schedules and meet all study requirements
  4. Patient has recovered from the toxic effects of prior therapy, and is at least 30 days from the most recent cytotoxic therapy, prior to enrollment
  5. Patient has adequate hematologic, hepatic, and renal function as defined by:

    • ANC ≥1000/µL
    • Platelet count ≥100,000/µL
    • Total bilirubin ≤1.5 mg/dL
    • Aspartate aminotransferase/serum glutamic-oxaloacetic transaminase (AST/SGOT), alanine aminotransferase/serum glutamic-pyruvic transaminase (ALT/SGPT), and gamma-glutamyltransferase (GGT) ≤2.5 xupper limit of normal (ULN) (AST/ALT/GGT ≤5 xULN if documented hepatic involvement with lymphoma)
    • Creatinine ≤2.0 mg/dL or calculated creatinine clearance ≥50 mL/min
  6. Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  7. Females of childbearing potential are to agree to practice a medically acceptable contraceptive regimen (including a barrier method) from study treatment initiation until at least 30 days after the last administration of Folotyn or leucovorin, whichever is last, and are to have a negative urine beta human chorionic gonadotropin (β-HCG) pregnancy test within 14 days prior to the first day of study treatment. Females who are postmenopausal for at least 1 year (defined as >12 months since last menses) or are surgically sterilized do not require this test
  8. Male patients are to agree to use a barrier method of contraception from study treatment initiation until at least 90 days after the last administration of Folotyn

Exclusion Criteria:

  1. Patient has congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification
  2. Patient has uncontrolled hypertension
  3. Patient has known, uncontrolled human immunodeficiency virus (HIV)-positive diagnosis
  4. Patient has symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
  5. Patient has an active uncontrolled infection, underlying medical condition, or other serious illness that would impair the ability of the patient to receive protocol treatment
  6. Patient has had major surgery within 14 days prior to enrollment
  7. Patient has used any investigational drugs, biologics, or devices within 14 days prior to study treatment or plans to use any of these during the course of the study
  8. Patient has had previous exposure to Folotyn within 6 months of study enrollment
  9. Patient is pregnant or breast-feeding
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02106650
Other Study ID Numbers  ICMJE SPI-FOL-14-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Acrotech Biopharma LLC
Study Sponsor  ICMJE Acrotech Biopharma LLC
Collaborators  ICMJE Axis Clinicals Limited
Investigators  ICMJE
Study Director: Wasim Khan, MD Acrotech Biopharma LLC
PRS Account Acrotech Biopharma LLC
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP