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Peripheral T-Cell Lymphoma (PTCL)Phase 1NCT02594267

A Dose-Finding Study of Folotyn® (Pralatrexate Injection) Plus CHOP With Peripheral T-Cell Lymphoma (PTCL)

A Phase 1 study testing Pralatrexate Injection in people with Peripheral T-Cell Lymphoma (PTCL), run by Acrotech Biopharma Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral T-Cell Lymphoma (PTCL)
What is being tested?
Pralatrexate Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
48 participants
Where
4 sitesUnited States
Study dates
10 Nov 2015to 8 Oct 2020
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • Use of any investigational drugs, biologics, or devices within 30 days prior or during the study treatment.
  • Previous exposure to pralatrexate.
  • Pregnant or breastfeeding.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • MD Anderson

    Houston, Texas, 77030

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Seattle Cancer Care Alliance/University of Washington

    Seattle, Washington, 98109

Other trials in United States

About this study

Official title: 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)

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).

Read the detailed description

This is a Phase 1, open-label, multicenter, two-part, dose-finding, dose-escalation study.

The study is divided into two parts:

Part 1

Up to five sequential dose cohorts will enroll a maximum of 6 patients each. Escalation of the pralatrexate dose, after CHOP administration (Fol-CHOP), will continue in a traditional 3+3 design, until determination of the MTD. If the MTD is not reached, the Maximum Administered Dose (MAD) of pralatrexate in combination with CHOP will be 30 mg/m2 IV on Days 1 and 8 of each 21-day cycle for up to 6 cycles.

The first cohort will begin with three patients with dose A and CHOP at full dose. If none of the first three patients experiences a Dose-Limiting Toxicity (DLT), the next three patients will be enrolled in next higher dose cohort. If one of the first three patients in the first cohort experiences DLTs, an additional three patients will be enrolled into that cohort. If 2 or 3 of the first 3 patients experience DLTs, then the MTD is not found.

For cohorts 2, 3, 4, and 5, If none of the first three patients experiences a DLT, the next three patients will be enrolled in next higher dose cohort. If one of the first three patients in the first cohort experiences DLTs, an additional three patients will be enrolled into that cohort. If 2 or 3 of the first 3 patients experience DLTs, then the previous cohort will be considered the MTD and up to an additional 10 patients will be enrolled at that dose in Part 2 of the study.

Part 2

Once the MTD for the Fol-CHOP regimen has been established in Part 1 of the study, an additional 10 patients will be treated at the MTD (or MAD if MTD not reached) to confirm tolerability. Additionally, the PK of the established MTD of pralatrexate, when administered with CHOP at full dose, will be evaluated in these 10 patients.

Being tested
Pralatrexate Injection
Keywords
PTCL, Peripheral T-Cell Lymphoma, Folotyn, Pralatrexate, CHOP
Medical subject headings
Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pralatrexate InjectionDrug

    Also called Folotyn

    Drug: Folotyn (Pralatrexate Injection)

    CHOP : Cyclophosphamide, Doxorubicin, Vincristine, \& Prednisone

Study groups in NCT02594267
Study groupRoleWhat they receive
Part 1: Dose Finding, Cohort 1ExperimentalDose 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.
Receives: Drug: Pralatrexate Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: 126 Days

Secondary outcomes (7)

  1. Number of participants with treatment emergent adverse events (TEAEs) using CTCAE version 4.03

    Investigator will question the patient at every visit about AEs and intercurrent illnesses.

    Measured: 126 Days

  2. Objective Response Rate

    To evaluate the Objective Response Rate (ORR) of 6 cycles of Fol-CHOP

    Measured: 126 Days

  3. Plasma concentration of pralatrexate in combination with CHOP

    Measure the concentration of pralatrexate to evaluate the pharmacokinetics of pralatrexate when given in combination with CHOP using non-compartmental analysis.

    Measured: 126 Days

  4. Pharmacokinetics: Area Under the Curve (AUC)

    Non-compartmental Analysis

    Measured: 126 Days

  5. Pharmacokinetics: Maximum Concentration (Cmax)

    Non-compartmental Analysis

    Measured: 126 Days

  6. Pharmacokinetics: Time to Maximum concentration (Tmax)

    Non-compartmental Analysis

    Measured: 126 Days

  7. Pharmacokinetics: Clearance (CL)

    Non-compartmental Analysis

    Measured: 126 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2015 (estimated)
  2. Study start10 Nov 2015
  3. Primary completion7 Apr 2017
  4. Study completion8 Oct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02594267
Sponsor's protocol ID
SPI-FOL-101
Status last verified
Jul 2021
First submitted
25 Sep 2015
Last updated
27 Jul 2021
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 38029357

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Pralatrexate Injection in people with Peripheral T-Cell Lymphoma (PTCL), run by Acrotech Biopharma Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum Tolerated Dose (time frame: 126 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02594267, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2021.

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