Difference between revisions of "Cutaneous T-cell lymphoma - null regimens"
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[[#top|Back to Top]] | [[#top|Back to Top]] | ||
</div> | </div> | ||
| − | The purpose of this page is to provide references to "null therapy" such as placebo and observation. | + | The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the [[Cutaneous T-cell lymphoma|main CTCL page]] for regimens that include active anticancer treatment. |
{{TOC limit|limit=3}} | {{TOC limit|limit=3}} | ||
| + | |||
| + | =Early-stage disease= | ||
| + | ==Placebo== | ||
| + | <div class="toccolours" style="background-color:#eeeeee"> | ||
| + | ===Regimen=== | ||
| + | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| + | !style="width: 20%"|Study | ||
| + | !style="width: 20%"|Dates of enrollment | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Evidence|Evidence]] | ||
| + | !style="width: 20%"|Comparator | ||
| + | !style="width: 20%"|[[Levels_of_Evidence#Comparative_efficacy|Comparative Efficacy]] | ||
| + | |- | ||
| + | |[https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9301595/ Kim et al. 2022 (FLASH)] | ||
| + | |2015-12 to 2020-11 | ||
| + | |style="background-color:#1a9851"|Phase 3 (C) | ||
| + | |[[#Hypericin_monotherapy_777|Hypericin]] | ||
| + | | style="background-color:#fc8d59" |Seems to have inferior cycle 1 ILRR (primary endpoint)<br>Cycle 1 ILRR: 4% vs 16% | ||
| + | |- | ||
| + | |} | ||
| + | ''No active anticancer treatment.'' | ||
| + | </div> | ||
| + | ===References=== | ||
| + | #'''FLASH:''' Kim EJ, Mangold AR, DeSimone JA, Wong HK, Seminario-Vidal L, Guitart J, Appel J, Geskin L, Lain E, Korman NJ, Zeitouni N, Nikbakht N, Dawes K, Akilov O, Carter J, Shinohara M, Kuzel TM, Piette W, Bhatia N, Musiek A, Pariser D, Kim YH, Elston D, Boh E, Duvic M, Huen A, Pacheco T, Zwerner JP, Lee ST, Girardi M, Querfeld C, Bohjanen K, Olsen E, Wood GS, Rumage A, Donini O, Haulenbeek A, Schaber CJ, Straube R, Pullion C, Rook AH, Poligone B. Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Sep 1;158(9):1031-1039. [https://doi.org/10.1001/jamadermatol.2022.2749 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc9301595/ link to PMC article] [https://pubmed.ncbi.nlm.nih.gov/35857290/ PubMed] [https://clinicaltrials.gov/study/NCT02448381 NCT02448381] | ||
=Relapsed or refractory= | =Relapsed or refractory= | ||
==Placebo== | ==Placebo== | ||
| − | + | <div class="toccolours" style="background-color:#eeeeee"> | |
| − | |||
===Regimen=== | ===Regimen=== | ||
{| class="wikitable sortable" style="width: 100%; text-align:center;" | {| class="wikitable sortable" style="width: 100%; text-align:center;" | ||
| Line 23: | Line 45: | ||
|NR | |NR | ||
|style="background-color:#1a9851"|Phase 3 (C) | |style="background-color:#1a9851"|Phase 3 (C) | ||
| − | |[[Cutaneous_T-cell_lymphoma#Denileukin_diftitox_monotherapy|Denileukin diftitox]] | + | |1. [[Cutaneous_T-cell_lymphoma#Denileukin_diftitox_monotherapy|Denileukin diftitox]]; 9 mcg/kg<br>2. [[Cutaneous_T-cell_lymphoma#Denileukin_diftitox_monotherapy|Denileukin diftitox]]; 18 mcg/kg |
| style="background-color:#d73027" |Inferior PFS | | style="background-color:#d73027" |Inferior PFS | ||
|- | |- | ||
|} | |} | ||
| + | ''No active anticancer treatment.'' | ||
| + | </div> | ||
===References=== | ===References=== | ||
<!-- Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL. --> | <!-- Presented in part at the 43rd Annual Meeting of the American Society of Clinical Oncology, June 1-5, 2007, Chicago, IL; and the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL. --> | ||
| − | # '''L4389-11:''' Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. Epub 2010 Mar 8. [https://doi.org/10.1200/jco.2009.26.2386 link to original article] | + | # '''L4389-11:''' Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. Epub 2010 Mar 8. [https://doi.org/10.1200/jco.2009.26.2386 link to original article] [https://pubmed.ncbi.nlm.nih.gov/20212249/ PubMed] [https://clinicaltrials.gov/study/NCT00050999 NCT00050999] |
[[Category:Cutaneous T-cell lymphoma regimens]] | [[Category:Cutaneous T-cell lymphoma regimens]] | ||
Latest revision as of 12:13, 23 June 2024
The purpose of this page is to provide references to "null therapy" such as placebo and observation. These references provide further insight into the historical development of the treatment landscape. See the main CTCL page for regimens that include active anticancer treatment.
Early-stage disease
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Kim et al. 2022 (FLASH) | 2015-12 to 2020-11 | Phase 3 (C) | Hypericin | Seems to have inferior cycle 1 ILRR (primary endpoint) Cycle 1 ILRR: 4% vs 16% |
No active anticancer treatment.
References
- FLASH: Kim EJ, Mangold AR, DeSimone JA, Wong HK, Seminario-Vidal L, Guitart J, Appel J, Geskin L, Lain E, Korman NJ, Zeitouni N, Nikbakht N, Dawes K, Akilov O, Carter J, Shinohara M, Kuzel TM, Piette W, Bhatia N, Musiek A, Pariser D, Kim YH, Elston D, Boh E, Duvic M, Huen A, Pacheco T, Zwerner JP, Lee ST, Girardi M, Querfeld C, Bohjanen K, Olsen E, Wood GS, Rumage A, Donini O, Haulenbeek A, Schaber CJ, Straube R, Pullion C, Rook AH, Poligone B. Efficacy and Safety of Topical Hypericin Photodynamic Therapy for Early-Stage Cutaneous T-Cell Lymphoma (Mycosis Fungoides): The FLASH Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2022 Sep 1;158(9):1031-1039. link to original article link to PMC article PubMed NCT02448381
Relapsed or refractory
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Prince et al. 2010 (L4389-11) | NR | Phase 3 (C) | 1. Denileukin diftitox; 9 mcg/kg 2. Denileukin diftitox; 18 mcg/kg |
Inferior PFS |
No active anticancer treatment.
References
- L4389-11: Prince HM, Duvic M, Martin A, Sterry W, Assaf C, Sun Y, Straus D, Acosta M, Negro-Vilar A. Phase III placebo-controlled trial of denileukin diftitox for patients with cutaneous T-cell lymphoma. J Clin Oncol. 2010 Apr 10;28(11):1870-7. Epub 2010 Mar 8. link to original article PubMed NCT00050999