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

Information source: Polish Lymphoma Research Group
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Lymphoma, T-Cell, Cutaneous; Mycosis Fungoides

Intervention: Methotrexate (Drug); Interferon Alfa-2b (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Polish Lymphoma Research Group

Official(s) and/or principal investigator(s):
Małgorzata Sokołowska Wojdyło, MD, PhD, Principal Investigator, Affiliation: Polish Lymphoma Research Group
Ewa Chmielowska, MD, PhD, Principal Investigator, Affiliation: Polish Lymphoma Research Group

Overall contact:
Ewa Chmielowska, MD, PhD, Phone: 48523743421, Email: eacagace@gmail.com

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Secondary outcome:

Number of Participants With Adverse Events

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

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Locations and Contacts

Ewa Chmielowska, MD, PhD, Phone: 48523743421, Email: eacagace@gmail.com

Centrum Onkologii im. prof. F. Łukaszczyka, Bydgoszcz 85-796, Poland; Recruiting
Ewa Chmielowska, MD, PhD, Phone: 48523743421, Email: eacagaca@gmail.com
Additional Information

Starting date: June 2014
Last updated: December 22, 2014

Page last updated: August 23, 2015

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