Mycosis Fungoides Clinical Trial
Official title:
A Phase II Pivotal Trial to Evaluate the Safety and Efficacy of Nitrogen Mustard (NM) 0.02% Ointment Formulations in Patients With Stage I or IIA Mycosis Fungoides (MF)
This study will evaluate the efficacy, tolerability and safety of the topical application of mechlorethamine (MCH) formulations in patients with stage I or IIA mycosis fungoides (MF).
The successful use of mechlorethamine (MCH) as a topical agent in the treatment of mycosis fungoides, a form of cutaneous T-cell lymphoma, was first reported in the late 1950s, and provided a rationale for skin-directed chemotherapy that minimized systemic toxicity. Since then, multiple investigators have demonstrated the safety and efficacy of topically applied MCH in the treatment of mycosis fungoides. This study will evaluate the efficacy (non-inferiority), tolerability and safety of topical application of MCH proprietary gel versus a compounded ointment formulation in Aquaphor in patients with stage I or IIA MF. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT02890368 -
Trial of Intratumoral Injections of TTI-621 in Subjects With Relapsed and Refractory Solid Tumors and Mycosis Fungoides
|
Phase 1 | |
| Not yet recruiting |
NCT02881749 -
Low Dose Total Skin Electron Beam Treatment (TSEBT) Followed by Maintenance Valchlor for Patients With Mycosis Fungoides
|
Phase 2 | |
| Completed |
NCT00051012 -
Study of ONTAK (Denileukin Diftitox) in Previously Treated Cutaneous T-Cell Lymphoma Patients
|
Phase 4 | |
| Terminated |
NCT03789864 -
Biodynamic Imaging Utility in Predicting Response to Gemcitabine Chemotherapy in Mycosis Fungoides
|
N/A | |
| Completed |
NCT01590732 -
Romidepsin, Ifosfamide, Carboplatin, and Etoposide in Treating Participants With Relapsed or Refractory Peripheral T-Cell Lymphoma
|
Phase 1 | |
| Recruiting |
NCT02848274 -
ID Of Prognostic Factors In Mycosis Fungoides/Sezary Syndrome
|
||
| Recruiting |
NCT00177268 -
Blood, Urine, and Tissue Collection for Cutaneous Lymphoma, Eczema, and Atopic Dermatitis Research
|
||
| Recruiting |
NCT05357794 -
Effectiveness of Concurrent Ultra-Low-Dose Total-Skin Electron Beam Therapy and Brentuximab Vedotin Given Quarterly Over 12 Months for Patients With Mycosis Fungoides
|
Phase 2 | |
| Completed |
NCT04955340 -
A Phase 1, Open-label Study of the Absorption, Metabolism, Excretion of [14C]-Resminostat
|
Phase 1 | |
| Recruiting |
NCT04960618 -
Pembrolizumab in Combination With Gemcitabine in People With Advanced Mycosis Fungoides or Sézary Syndrome
|
Phase 2 | |
| Completed |
NCT02883517 -
Cell-free Circulating DNA in Primary Cutaneous Lymphomas
|
||
| Active, not recruiting |
NCT02953301 -
Resminostat for Maintenance Treatment of Patients With Advanced Stage Mycosis Fungoides (MF) or Sézary Syndrome (SS)
|
Phase 2 | |
| Completed |
NCT00254332 -
Effect of Denileukin Diftitox on Immune System in CTCL Patients
|
N/A | |
| Completed |
NCT02296164 -
Clinical Study Assessing Outcomes, Adverse Events, Treatment Patterns, and Quality of Life in Patients Diagnosed With Mycosis Fungoides Cutaneous T-cell Lymphoma
|
||
| Recruiting |
NCT05680558 -
Photopheresis in Early-stage Mycosis Fungoides
|
Phase 2 | |
| Completed |
NCT00038376 -
Phase II Study Of Roferon and Accutane For Patients With T-Cell Malignancies
|
Phase 2 | |
| Recruiting |
NCT05879458 -
Ritlecitinib in CTCL
|
Phase 2 | |
| Recruiting |
NCT05414500 -
Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
|
Phase 1 | |
| Recruiting |
NCT05904522 -
Histopathological Changes in Mycosis Fungoides
|
N/A | |
| Recruiting |
NCT04256018 -
Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
|
Phase 2 |