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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2018-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Lymphoma, T-Cell, Cutaneous Mycosis Fungoides

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Methotrexate arm

Patients assigned to receive methotrexate

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

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

Interferon Alfa-2b

Patients assigned to receive Interferon alfa 2b

Group Type ACTIVE_COMPARATOR

Interferon Alfa-2b

Intervention Type DRUG

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

Interventions

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Methotrexate

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

Intervention Type DRUG

Interferon Alfa-2b

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

Intervention Type DRUG

Other Intervention Names

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Tranxene Intron A

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Subject has received prior systemic methotrexate or interferon therapy
2. Unacceptable methotrexate or interferon treatment toxicity in the past
3. 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
4. anorexia
5. major depression with suicidal ideation or suicide attempt in the past
6. Symptomatic congestive heart failure
7. Epilepsia or other symptomatic central nervous system dysfunction
8. active skin infection not related to underlying CTCL, active Tuberculosis, HIV infection
9. Subject is pregnant or lactating
10. Psychiatric illness/social situation that would limit compliance with study requirements

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No