Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas

Sponsor

Polish Lymphoma Research Group (Other)

Overall Status

Terminated

CT.gov ID

NCT02323659

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma, T-Cell, Cutaneous Mycosis Fungoides	Drug: Methotrexate Drug: Interferon Alfa-2b	Phase 4

Detailed Description

Methotrexate and interferon are widely used drugs in treatment in patients with cutaneous T-cell Lymphomas. Efficacy and safety of both drugs have never been compared directly in one study.

Patients will be randomly assigned to receive Methotrexate or Interferon Alfa 2b. Treatment will continue until disease progression or the development of intolerable toxicities. Study is conducted to analyse and compare efficacy, safety and quality of life provided by Methotrexate or Interferon Alfa 2b.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas

Actual Study Start Date :

Jun 1, 2014

Actual Primary Completion Date :

Mar 1, 2018

Actual Study Completion Date :

Mar 31, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Methotrexate arm Patients assigned to receive methotrexate	Drug: Methotrexate Methotrexate 20mg per dose, administered orally, once every week Other Names: Tranxene
Active Comparator: Interferon Alfa-2b Patients assigned to receive Interferon alfa 2b	Drug: Interferon Alfa-2b Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week Other Names: Intron A

Arm

Intervention/Treatment

Active Comparator: Methotrexate arm

Patients assigned to receive methotrexate

Drug: Methotrexate

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

Other Names:

Tranxene

Active Comparator: Interferon Alfa-2b

Patients assigned to receive Interferon alfa 2b

Drug: Interferon Alfa-2b

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

Other Names:

Intron A

Outcome Measures

Primary Outcome Measures

Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system) [3 years]
Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)

Secondary Outcome Measures

Number of Participants With Adverse Events [3 years]
Quality of Life as measured by the Dermatology Life Quality Index (DLQI) [3 years]
Evaluation according to Dermatology Life Quality Index (DLQI)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centrum Onkologii im. prof. F. Łukaszczyka	Bydgoszcz		Poland	85-796

Sponsors and Collaborators

Polish Lymphoma Research Group

Investigators

Principal Investigator: Małgorzata Sokołowska Wojdyło, MD, PhD, Polish Lymphoma Research Group
Principal Investigator: Ewa Chmielowska, MD, PhD, Polish Lymphoma Research Group