NCT03150602

Brief Summary

This study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
22

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2016

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

August 30, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 5, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 12, 2017

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

May 12, 2017

Status Verified

May 1, 2017

Enrollment Period

4.3 years

First QC Date

May 5, 2017

Last Update Submit

May 10, 2017

Conditions

Peripheral T Cell LymphomaProgression, Disease

Outcome Measures

Primary Outcomes (1)

  • Objective Response Rate

    Objective response rate (ORR) to pralatrexate treatment in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)

    Up to 35 weeks

Secondary Outcomes (14)

  • Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    Up to 40 weeks

  • Overall survival

    Up to 5 years

  • Progression-free survival

    Up to 5 years

  • Completion response rate

    Up to 5 years

  • Partial response rate

    Up to 5 years

  • +9 more secondary outcomes

Study Arms (1)

Pralatrexate treatment

EXPERIMENTAL

Pralatrexate will initially be administered at a dose of 30 mg/m2/week on days 1, 8, 15, 22, 29 and 36 for 6 weeks in a 7-week cycle (cycle: 6 weeks + 1 week rest). The scheduled date can be done within a window time of plus or minus 1 day

Drug: Pralatrexate

Interventions

PralatrexateDRUG

This is a single arm study. Pralatrexate will be administered via IV over 3-5 minutes into a IV line containing normal saline (0.9% sodium chloride, NaCl) with the initial dose of 30 mg/m2/week on days 1, 8, 15, 22, 29, and 36 for 6 weeks in a 7-week cycle. The scheduled date can be done within a window time of plus or minus 1 day. The pralatrexate dose may be reduced to 20 mg/m2/week or omit if a patient experiences adverse events. Pralatrexate administration can be up to 5 cycles or until subject meets withdrawal criteria.

Also known as: Folotyn
Pralatrexate treatment

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • At least 20 years of age, inclusive
  • Patients with histologically/cytologically confirmed PTCL using either: NCCN diagnosis criteria, the Revised European American Lymphoma (REAL), and World Health Organization (WHO) disease classification (PTCL histology/cytology subtypes diagnosed by site investigators, PTCL histology/cytology subtypes rechecked by study central pathology lab):
  • At least 5 patients with Peripheral T-cell lymphoma, NOS
  • At least 5 patients with Angioimmunoblastic T-cell lymphoma
  • At least 5 patients with Extranodal NK/T-cell lymphoma, nasal type
  • Enteropathy-type T-cell lymphoma
  • Hepatosplenic T-cell lymphoma
  • Subcutaneous panniculitis-like T-cell lymphoma
  • Adult T-cell lymphoma/leukemia (human T-cell leukemia virus \[HTLV\] 1+)
  • Patients with documented progressive disease (PD) failed after prior treatment
  • Patients may not have received an experimental drug as their only prior therapy
  • Patient has had at least 1 biopsy from initial diagnosis of PTCL or in the relapsed setting to confirm PTCL subtypes
  • Patient has recovered from the toxic effects of prior therapy
  • Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 2.
  • Adequate hematological, hepatic, and renal function as defined by: absolute neutrophil count (ANC) ≥ 1000/µL, platelet count ≥ 100,000/µL (and ≥ 50,000/µL for any following dose), total bilirubin ≤ 1.5 mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 X upper limit of normal (ULN) (AST/ALT \< 5 X ULN if documented hepatic involvement with lymphoma), creatinine ≤ 1.5 mg/dL or a calculated creatinine clearance ≥ 50 mL/min.
  • +3 more criteria

You may not qualify if:

  • Patient has following subtypes (histologically/cytologically confirmed) of PTCL
  • Anaplastic large cell lymphoma, ALK +/-
  • Patient has: Precursor T/NK neoplasms, with the exception of blastic NK lymphoma
  • T-cell prolymphocytic leukemia (T-PLL)
  • T-cell large granular lymphocytic leukemia
  • Mycosis fungoides and transformed mycosis fungoides
  • Sézary syndrome
  • Primary cutaneous CD30+ disorders: Anaplastic large cell lymphoma and lymphomatoid papulosis
  • Patient has: Extranodal NK/T-cell lymphoma, nasal type with local recurrence
  • Active concurrent malignancy (except for non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 5 years.
  • Congestive heart failure Class III/IV according to the New York Heart Association's Heart Failure guidelines.
  • Patients with human immunodeficiency virus (HIV)-positive diagnosis and are receiving combination anti-retroviral therapy.
  • Current or the history of brain metastases or central nervous system (CNS) diseases
  • Have undergone allogeneic stem cell transplant
  • Relapsed less than 75 days from time of autologous stem cell transplant
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ntional Taiwan University Hospital

Taipei, 100, Taiwan

RECRUITING

Related Publications (7)

  • Savage KJ. Peripheral T-cell lymphomas. Blood Rev. 2007 Jul;21(4):201-16. doi: 10.1016/j.blre.2007.03.001. Epub 2007 May 18.

    PMID: 17512649BACKGROUND

  • Shustov A. Novel therapies for peripheral T-cell lymphomas. Ther Adv Hematol. 2013 Jun;4(3):173-87. doi: 10.1177/2040620713481980.

    PMID: 23730495BACKGROUND

  • Savage KJ, Harris NL, Vose JM, Ullrich F, Jaffe ES, Connors JM, Rimsza L, Pileri SA, Chhanabhai M, Gascoyne RD, Armitage JO, Weisenburger DD; International Peripheral T-Cell Lymphoma Project. ALK- anaplastic large-cell lymphoma is clinically and immunophenotypically different from both ALK+ ALCL and peripheral T-cell lymphoma, not otherwise specified: report from the International Peripheral T-Cell Lymphoma Project. Blood. 2008 Jun 15;111(12):5496-504. doi: 10.1182/blood-2008-01-134270. Epub 2008 Apr 2.

    PMID: 18385450BACKGROUND

  • Society TLL, Peripheral T-Cell Lymphoma Facts, 2014.

    BACKGROUND

  • Wang ES, O'Connor O, She Y, Zelenetz AD, Sirotnak FM, Moore MA. Activity of a novel anti-folate (PDX, 10-propargyl 10-deazaaminopterin) against human lymphoma is superior to methotrexate and correlates with tumor RFC-1 gene expression. Leuk Lymphoma. 2003 Jun;44(6):1027-35. doi: 10.1080/1042819031000077124.

    PMID: 12854905BACKGROUND

  • Krug LM, Ng KK, Kris MG, Miller VA, Tong W, Heelan RT, Leon L, Leung D, Kelly J, Grant SC, Sirotnak FM. Phase I and pharmacokinetic study of 10-propargyl-10-deazaaminopterin, a new antifolate. Clin Cancer Res. 2000 Sep;6(9):3493-8.

    PMID: 10999734BACKGROUND

  • O'Connor OA, Pro B, Pinter-Brown L, Bartlett N, Popplewell L, Coiffier B, Lechowicz MJ, Savage KJ, Shustov AR, Gisselbrecht C, Jacobsen E, Zinzani PL, Furman R, Goy A, Haioun C, Crump M, Zain JM, Hsi E, Boyd A, Horwitz S. Pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma: results from the pivotal PROPEL study. J Clin Oncol. 2011 Mar 20;29(9):1182-9. doi: 10.1200/JCO.2010.29.9024. Epub 2011 Jan 18.

    PMID: 21245435BACKGROUND

MeSH Terms

Conditions

Lymphoma, T-Cell, PeripheralDisease Progression

Interventions

10-propargyl-10-deazaaminopterin

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Bor-Sheng Ko, PhD

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bor-Sheng Ko, PhD

CONTACT

886-23123456kevinkomd@gmail.com

Brook Chung, MSc

CONTACT

886-87297521brook.chung@mundipharma.com.tw

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2017

First Posted

May 12, 2017

Study Start

August 30, 2016

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

May 12, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)