NCT02323659

Brief Summary

Comparison of methotrexate versus interferon-alfa 2b on efficacy, safety and quality of life in patients with primary cutaneous T-cell lymphomas after failure of topical or phototherapy treatment.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2014

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

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

June 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

January 13, 2022

Status Verified

October 1, 2018

Enrollment Period

3.8 years

First QC Date

December 12, 2014

Last Update Submit

December 23, 2021

Conditions

Lymphoma, T-Cell, CutaneousMycosis Fungoides

Keywords

Mycosis FungoidesCutaneous T-Cell LymphomaInterferonMethotrexate

Outcome Measures

Primary Outcomes (1)

  • Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)

    Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)

    3 years

Secondary Outcomes (2)

  • Number of Participants With Adverse Events

    3 years

  • Quality of Life as measured by the Dermatology Life Quality Index (DLQI)

    3 years

Study Arms (2)

Methotrexate arm

ACTIVE COMPARATOR

Patients assigned to receive methotrexate

Drug: Methotrexate

Interferon Alfa-2b

ACTIVE COMPARATOR

Patients assigned to receive Interferon alfa 2b

Drug: Interferon Alfa-2b

Interventions

MethotrexateDRUG

Methotrexate 20mg per dose, administered orally, once every week

Also known as: Tranxene
Methotrexate arm
Interferon Alfa-2bDRUG

Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week

Also known as: Intron A
Interferon Alfa-2b

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically confirmed primary cutaneous T-cell lymphoma (CTCL)
  • Age ≥ 18 years
  • Performance status WHO\<=2
  • Subject must have adequate bone marrow, renal and hepatic function
  • Topical and phototherapy treatment failure in the past
  • Signed informed consent

You may not qualify if:

  • Subject has received prior systemic methotrexate or interferon therapy
  • Unacceptable methotrexate or interferon treatment toxicity in the past
  • Inadequate bone marrow, renal or hepatic function as follows:
  • Bone Marrow: Absolute neutrophil count (ANC) \< 1,500/mm 3 (1.5 × 10 9 /L); Platelets \<100,000/mm 3 (100 × 10 9 /L); Hemoglobin \< 9.0 g/dL (1.4 mmol/L);
  • Renal function: Creatinine \>1.5 x Upper limit of normal (ULN)
  • Hepatic function: Aspartate and Alanine transaminase (AST and ALT) \>3× ULN; bilirubin \> 1.5 × ULN
  • Active hepatitis B or hepatitis C
  • anorexia
  • major depression with suicidal ideation or suicide attempt in the past
  • Symptomatic congestive heart failure
  • Epilepsia or other symptomatic central nervous system dysfunction
  • active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection
  • Subject is pregnant or lactating
  • Psychiatric illness/social situation that would limit compliance with study requirements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centrum Onkologii im. prof. F. Łukaszczyka

Bydgoszcz, 85-796, Poland

Location

Related Publications (1)

  • Valipour A, Jager M, Wu P, Schmitt J, Bunch C, Weberschock T. Interventions for mycosis fungoides. Cochrane Database Syst Rev. 2020 Jul 7;7(7):CD008946. doi: 10.1002/14651858.CD008946.pub3.

    PMID: 32632956DERIVED

MeSH Terms

Conditions

Lymphoma, T-Cell, CutaneousMycosis Fungoides

Interventions

MethotrexateClorazepate DipotassiumInterferon alpha-2Introns

Condition Hierarchy (Ancestors)

Lymphoma, T-CellLymphoma, Non-HodgkinLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

AminopterinPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzodiazepinesBenzazepinesInterferon-alphaInterferon Type IInterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsProteinsBiological FactorsDNA, IntergenicGenome ComponentsGenomeGenetic StructuresGenetic PhenomenaGene ComponentsGenes

Study Officials

  • Małgorzata Sokołowska Wojdyło, MD, PhD

    Polish Lymphoma Research Group

    PRINCIPAL INVESTIGATOR

  • Ewa Chmielowska, MD, PhD

    Polish Lymphoma Research Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2014

First Posted

December 23, 2014

Study Start

June 1, 2014

Primary Completion

March 1, 2018

Study Completion

March 31, 2018

Last Updated

January 13, 2022

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

PL(1)