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NCT02323659
Comparison of Methotrexate Versus Interferon-alfa 2b on Efficacy, Safety and Quality of Life in Patients With Primary Cutaneous T-cell Lymphomas
Phase 4 trial testing Methotrexate in Lymphoma, T-Cell, Cutaneous in 100 participants. Terminated before completion.
1 March 2018
Quick facts
| Lead sponsor | Polish Lymphoma Research Group |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 June 2014 |
| Primary completion | 1 March 2018 |
| Estimated completion | 31 March 2018 |
| Sites | 1 location across Poland |
Drugs / interventions tested
- Methotrexate — full drug profile →
- Interferon Alfa-2b (INTERFERON ALFA-2B) — full drug profile →
Conditions studied
- Lymphoma, T-Cell, Cutaneous — all drugs for Lymphoma, T-Cell, Cutaneous →
- Mycosis Fungoides — all drugs for Mycosis Fungoides →
Sponsor
Polish Lymphoma Research Group
Who can join
18 and older, any sex, with Lymphoma, T-Cell, Cutaneous or Mycosis Fungoides. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
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)
Sponsor's own description
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.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Interventions for mycosis fungoides.
Valipour A, Jäger M, Wu P, Schmitt J, et al · · 2020 · cited 17× · PMID 32632956 · DOI 10.1002/14651858.cd008946.pub3 -
Efficacy, quality of life, and safety of methotrexate versus interferon in head-to-head treatment in advanced stages of mycosis fungoides and Sezary syndrome. Prospective trial (NCT02323659).
Chmielowska E, Sokołowska-Wojdyło M, Olszewska B, Studziński M, et al · · 2021 · cited 1× · PMID 36751548 · DOI 10.5114/ada.2021.106206
Verify or expand the search:
- PubMed search for NCT02323659
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Methotrexate
Trials testing the same drug.
- NCT07498465 — A Study to Find the Highest Dose of SNDX-5613 (Revumenib) as a Treatment Option After Hematopoietic Stem Cell Transplant · Phase 1 · withdrawn
- NCT07072585 — Testing the Addition of Daratumumab to Chemotherapy for Treating Patients With Newly-Diagnosed T-Cell Lymphoblastic Leuk · Phase 2, PHASE3 · not yet recruiting
- NCT07321912 — Eflornithine (DFMO) for Ewing Sarcoma and Osteosarcoma · Phase 2 · not yet recruiting
- NCT07446400 — A Trial to Examine the Interaction of Repinatrabit With Ethinyl Estradiol/Norethindrone, Metformin,Carbamazepine, Rosuva · Phase 1 · recruiting
- NCT07477691 — Immune Modulation During Palynziq® Treatment in Adults (IMPALA) · Phase 4 · not yet recruiting
Other recruiting trials for Lymphoma, T-Cell, Cutaneous
Currently open trials in the same condition.
- NCT03902184 — IPH4102 Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma · Phase 2 · active not recruiting
Other Polish Lymphoma Research Group trials
Trials by the same sponsor.
- NCT04716075 — Acalabrutinib in CLL and MCL Patients Subjected to Allogeneic Hematopoietic Stem Cell Transplantation (alloSCT) · Phase 2 · completed
- NCT03229382 — Efficacy and Safety of Obinutuzumab Preemptive Treatment at the Time of the Molecular Relapse · Phase 2 · terminated
- NCT03615664 — The Efficacy of Salvage BGD With autoSCT Consolidation in Advanced Classical HL Patients Not Responding to ABVD · Phase 2 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02323659 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Polish Lymphoma Research Group
- Last refreshed: 23 December 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02323659.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing