A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)
A Phase 1, Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (CHOP) in Patients With Peripheral T-Cell Lymphoma (PTCL)
1 other identifier
interventional
48
1 country
4
Brief Summary
The purpose of this study is to evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2015
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedStudy Start
First participant enrolled
November 10, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 7, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 8, 2020
CompletedJuly 27, 2021
July 1, 2021
1.4 years
September 25, 2015
July 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maximum Tolerated Dose
To evaluate the Maximum Tolerated Dose (MTD) of pralatrexate in combination with cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen in patients with newly diagnosed peripheral T-cell lymphoma (PTCL)
126 Days
Secondary Outcomes (7)
Number of participants with treatment emergent adverse events (TEAEs) using CTCAE version 4.03
126 Days
Objective Response Rate
126 Days
Plasma concentration of pralatrexate in combination with CHOP
126 Days
Pharmacokinetics: Area Under the Curve (AUC)
126 Days
Pharmacokinetics: Maximum Concentration (Cmax)
126 Days
- +2 more secondary outcomes
Study Arms (1)
Part 1: Dose Finding, Cohort 1
EXPERIMENTALDose finding Phase Intervention: Folotyn (Pralatrexate Injection) CHOP: Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone The first cohort will begin with three patients with dose A of pralatrexate plus CHOP at full dose. The second cohort will begin with three patients with dose B of pralatrexate plus CHOP at full dose. The third cohort will begin with three patients with dose C of pralatrexate plus CHOP at full dose. The fourth cohort will begin with three patients with dose D of pralatrexate plus CHOP at full dose. The fifth cohort will begin with three patients with dose E of pralatrexate plus CHOP at full dose. Part 2: Dose Expansion, Additional ten patients will be enrolled at the MTD or MAD (if the MTD is not reached) plus CHOP at full dose in this part of the study. Blood samples for PK analysis of pralatrexate will be collected at various intervals pre and post pralatrexate injection during cycle 1, Dose 1.
Interventions
Drug: Folotyn (Pralatrexate Injection) CHOP : Cyclophosphamide, Doxorubicin, Vincristine, \& Prednisone
Eligibility Criteria
You may qualify if:
- Age 18 years or above
- Adequate hematologic, hepatic, and renal function
- Histologically confirmed, new diagnosis of PTCL
- Eligible for CHOP regimen
- Measurable disease based on Cheson 2007 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status \< 2
- Willing to perform at least two methods of contraception
- Negative pregnancy test of females with childbearing potential.
You may not qualify if:
- Active concurrent malignancy (except non melanoma skin cancer or carcinoma in situ of the cervix) or life threatening disease. If there is a history of prior malignancies or life threatening diseases, the patient must be disease free for at least 5 years.
- Congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification.
- Uncontrolled hypertension
- Central nervous system (CNS) metastases .
- 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 30 days prior to enrollment.
- Use of any investigational drugs, biologics, or devices within 30 days prior or during the study treatment.
- Previous exposure to pralatrexate.
- Pregnant or breastfeeding.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Acrotech Biopharma Inc.lead
- Axis Clinicals Limitedcollaborator
Study Sites (4)
Mayo Clinic
Rochester, Minnesota, 55905, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
MD Anderson
Houston, Texas, 77030, United States
Seattle Cancer Care Alliance/University of Washington
Seattle, Washington, 98109, United States
Related Publications (1)
Iyer SP, Johnston PB, Barta SK. Pralatrexate injection combined with CHOP for treatment of PTCL: results from the Fol-CHOP dose-finding phase 1 trial. Blood Adv. 2024 Jan 23;8(2):353-364. doi: 10.1182/bloodadvances.2023011095.
PMID: 38029357DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Erard Gilles, MD
Navitas Life Sciences Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2015
First Posted
November 3, 2015
Study Start
November 10, 2015
Primary Completion
April 7, 2017
Study Completion
October 8, 2020
Last Updated
July 27, 2021
Record last verified: 2021-07