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 EventsQuality 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
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