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Relapsed Peripheral T-Cell LymphomaPhase 2NCT02106650

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

A Phase 2 study testing Folotyn and Leucovorin, Folic Acid and Vitamin B12 in people with Relapsed Peripheral T-Cell Lymphoma and Refractory Peripheral T-Cell Lymphoma, run by Acrotech Biopharma Inc. at 3 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

This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Folotyn and Leucovorin, Folic Acid and Vitamin B12
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesUnited States
Study dates
Jul 2014to Jun 2019
Phase
Phase 2
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

  • Patient is diagnosed with hematological malignancies including PTCL and CTCL and are eligible for treatment with a dose of 30 mg/m^2
  • Patient is at least 18 years of age
  • 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
  • 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
  • Patient has adequate hematologic, hepatic, and renal function as defined by:
  • ANC ≥1000/µL
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  • 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
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
  • 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
  • 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

Who cannot join

  • Patient has congestive heart failure Class III/IV according to the New York Heart Association (NYHA) Functional Classification
  • Patient has uncontrolled hypertension
  • Patient has known, uncontrolled human immunodeficiency virus (HIV)-positive diagnosis
  • Patient has symptomatic central nervous system (CNS) metastases or lesions for which treatment is required. Patients who received prophylactic CNS treatment are eligible
  • 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
  • Patient has had major surgery within 14 days prior to enrollment
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  • 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
  • Patient has had previous exposure to Folotyn within 6 months of study enrollment
  • Patient is pregnant or breast-feeding

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • City of Hope

    Duarte, California, 91010

  • Seattle Cancer Care Alliance

    Seattle, Washington, 98109

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

Other trials in United States

About this study

Official title: 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

This study is to evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.

Read the 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.

Being tested
Folotyn and Leucovorin, Folic Acid, Vitamin B12
Keywords
Relapsed PTCL, Refractory PTCL
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.

  • Folotyn and LeucovorinDrug

    Also called Pralatrexate (Folotyn)

  • Folic AcidDrug

    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.

  • Vitamin B12Drug

    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 groups in NCT02106650
Study groupRoleWhat they receive
Folotyn and LeucovorinExperimentalFolotyn 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.
Receives: Drug: Folotyn and Leucovorin; Drug: Folic Acid; Drug: Vitamin B12

What is being measured

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

  1. Grade 2 Oral Mucositis Prevention

    To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 2 or higher oral mucositis.

    Measured: 15 weeks

Secondary outcomes (5)

  1. Grade 3 Oral Mucositis Prevention

    To evaluate the effect of leucovorin in preventing or reducing Folotyn-related Grade 3 or higher oral mucositis.

    Measured: 15 weeks

  2. Grade 2 Oral Mucositis Duration of first occurrence

    To evaluate the time to first occurrence of Folotyn-related Grade 2 or higher oral mucositis.

    Measured: 15 weeks

  3. Grade 2 Oral Mucositis Duration

    To evaluate the duration of Folotyn-related Grade 2 or higher oral mucositis.

    Measured: 15 weeks

  4. Effectiveness of Leucovorin in Folotyn dose modification

    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.

    Measured: 15 weeks

  5. Objective Response Rate

    To evaluate objective response rate (ORR) of Folotyn in patients with relapsed or refractory (R/R) PTCL.

    Measured: 17 weeks

Timeline

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

  1. First posted8 Apr 2014 (estimated)
  2. Study startJul 2014
  3. Primary completionOct 2018
  4. Study completionJun 2019

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
36 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02106650
Sponsor's protocol ID
SPI-FOL-14-201
Status last verified
Nov 2019
First submitted
28 Mar 2014
Last updated
20 Nov 2019
Results posted
No

Publications

  • Iyer SP, Dakhil S, Shinohara MM, Zain J, Acosta M, Foss F. Pralatrexate injection combined with oral leucovorin for mucositis management in PTCL/CTCL treatment: a multicenter phase 2 trial. Blood Neoplasia. 2024 Nov 2;2(1):100055. doi: 10.1016/j.bneo.2024.100055. eCollection 2025 Feb.

    PubMed 40546726

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Folotyn and Leucovorin, Folic Acid and Vitamin B12 in people with Relapsed Peripheral T-Cell Lymphoma and Refractory Peripheral T-Cell Lymphoma, run by Acrotech Biopharma Inc. at 3 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 13 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 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Grade 2 Oral Mucositis Prevention (time frame: 15 weeks). 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 NCT02106650, 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 20 Nov 2019.

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