Lymphoma, T-Cell, CutaneousPhase 4NCT02323659
Comparison of Methotrexate Versus Interferon-alfa 2b in Patients With Primary Cutaneous T-cell Lymphomas
A Phase 4 study testing Methotrexate and Interferon Alfa-2b in people with Lymphoma, T-Cell, Cutaneous and Mycosis Fungoides, run by Polish Lymphoma Research Group at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
- What is being tested?
- Methotrexate and Interferon Alfa-2b
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jun 2014to 31 Mar 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas
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.
Read the 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.
- Conditions
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
- Being tested
- Methotrexate, Interferon Alfa-2b
- Keywords
- Mycosis Fungoides, Cutaneous T-Cell Lymphoma, Interferon, Methotrexate
- Medical subject headings
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Also called Tranxene
Methotrexate 20mg per dose, administered orally, once every week
Interferon Alfa-2bDrug
Also called Intron A
Interferon Alfa-2b 3 million international units (MIU), administered 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate arm | Active comparator | Patients assigned to receive methotrexate Receives: Drug: Methotrexate |
| Interferon Alfa-2b | Active comparator | Patients assigned to receive Interferon alfa 2b Receives: Drug: Interferon Alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 3 years
Secondary outcomes (2)
Number of Participants With Adverse Events
Measured: 3 years
Quality of Life as measured by the Dermatology Life Quality Index (DLQI)
Evaluation according to Dermatology Life Quality Index (DLQI)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2014 (estimated)
- Study start1 Jun 2014
- Primary completionMar 2018
- Study completion31 Mar 2018
Why it stopped: Slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, T-Cell, CutaneousStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polish Lymphoma Research Group
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Małgorzata Sokołowska Wojdyło, MD, PhD, Principal investigator, Polish Lymphoma Research GroupEwa Chmielowska, MD, PhD, Principal investigator, Polish Lymphoma Research Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02323659
- Sponsor's protocol ID
- PLRG-14
- Status last verified
- Oct 2018
- First submitted
- 12 Dec 2014
- Last updated
- 13 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32632956
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas
- ClinicalTrials.gov ID
- NCT02323659
- Acronym / sponsor ID
- PLRG-14
- Conditions
- Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides
- Keywords
- Mycosis Fungoides, Cutaneous T-Cell Lymphoma, Interferon, Methotrexate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Polish Lymphoma Research GroupResearch network
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 23 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate arm | Active comparator | Drug: MethotrexatePatients assigned to receive methotrexate |
| Interferon Alfa-2b | Active comparator | Drug: Interferon Alfa-2bPatients assigned to receive Interferon alfa 2b |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (14 listed)
- 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:
- anorexia
- major depression with suicidal ideation or suicide attempt in the past
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateAlso: TranxeneMethotrexate 20mg per dose, administered orally, once every week | Drug | Methotrexate arm |
| Interferon Alfa-2bAlso: Intron AInterferon Alfa-2b 3 million international units (MIU), administered 3 times per week | Drug | Interferon Alfa-2b |
Primary outcome
Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system)
Time frame: 3 years
Evaluation according to modified Severity Weighted Assessment Tool (mSWAT scoring system)
2 secondary outcomes
Number of Participants With Adverse Events
Time frame: 3 years
Quality of Life as measured by the Dermatology Life Quality Index (DLQI)
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2022.
- Derived from this study: PubMed 32632956Valipour 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Małgorzata Sokołowska Wojdyło, MD, PhD principal investigator
Polish Lymphoma Research Group
Ewa Chmielowska, MD, PhD principal investigator
Polish Lymphoma Research Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methotrexate and Interferon Alfa-2b in people with Lymphoma, T-Cell, Cutaneous and Mycosis Fungoides, run by Polish Lymphoma Research Group at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 13 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate as measured by the modified Severity Weighted Assessment Tool (mSWAT scoring system) (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02323659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jan 2022.