Difference between revisions of "Immune thrombocytopenia - null regimens"
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|2005-02 to 2005-11 | |2005-02 to 2005-11 | ||
| style="background-color:#1a9851" |Randomized Phase 2 (C) | | style="background-color:#1a9851" |Randomized Phase 2 (C) | ||
| − | |[[#Eltrombopag_monotherapy|Eltrombopag]] | + | |[[Immune_thrombocytopenia#Eltrombopag_monotherapy|Eltrombopag]] |
| style="background-color:#d73027" |Inferior RR | | style="background-color:#d73027" |Inferior RR | ||
|- | |- | ||
| Line 27: | Line 27: | ||
|2005-03-01 to 2006-12-31 | |2005-03-01 to 2006-12-31 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Romiplostim_monotherapy|Romiplostim]] | + | |[[Immune_thrombocytopenia#Romiplostim_monotherapy|Romiplostim]] |
| style="background-color:#d73027" |Inferior durable platelet response | | style="background-color:#d73027" |Inferior durable platelet response | ||
|- | |- | ||
| Line 33: | Line 33: | ||
|2005-03-01 to 2006-12-31 | |2005-03-01 to 2006-12-31 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Romiplostim_monotherapy|Romiplostim]] | + | |[[Immune_thrombocytopenia#Romiplostim_monotherapy|Romiplostim]] |
| style="background-color:#d73027" |Inferior durable platelet response | | style="background-color:#d73027" |Inferior durable platelet response | ||
|- | |- | ||
| Line 39: | Line 39: | ||
|2006-02-06 to 2006-04-17 | |2006-02-06 to 2006-04-17 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Eltrombopag_monotherapy|Eltrombopag]] | + | |[[Immune_thrombocytopenia#Eltrombopag_monotherapy|Eltrombopag]] |
| style="background-color:#d73027" |Inferior RR | | style="background-color:#d73027" |Inferior RR | ||
|- | |- | ||
| Line 45: | Line 45: | ||
|2006-08-17 to 2011-06-30 | |2006-08-17 to 2011-06-30 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Rituximab_monotherapy|Rituximab]] | + | |[[Immune_thrombocytopenia#Rituximab_monotherapy|Rituximab]] |
| style="background-color:#ffffbf" |Did not meet primary endpoint of rate of treatment failure within 78 weeks | | style="background-color:#ffffbf" |Did not meet primary endpoint of rate of treatment failure within 78 weeks | ||
|- | |- | ||
| Line 51: | Line 51: | ||
|2006-11-22 to 2007-07-31 | |2006-11-22 to 2007-07-31 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Eltrombopag_monotherapy|Eltrombopag]] | + | |[[Immune_thrombocytopenia#Eltrombopag_monotherapy|Eltrombopag]] |
| style="background-color:#d73027" |Inferior RR | | style="background-color:#d73027" |Inferior RR | ||
|- | |- | ||
| Line 57: | Line 57: | ||
|2012-01-24 to 2014-09-03 | |2012-01-24 to 2014-09-03 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Romiplostim_monotherapy|Romiplostim]] | + | |[[Immune_thrombocytopenia#Romiplostim_monotherapy|Romiplostim]] |
| style="background-color:#d73027" |Inferior durable platelet response | | style="background-color:#d73027" |Inferior durable platelet response | ||
|- | |- | ||
| Line 63: | Line 63: | ||
|2012-02-06 to 2015-04-09 | |2012-02-06 to 2015-04-09 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Avatrombopag_monotherapy|Avatrombopag]] | + | |[[Immune_thrombocytopenia#Avatrombopag_monotherapy|Avatrombopag]] |
| style="background-color:#d73027" |Inferior cumulative weeks of platelet response without rescue therapy for bleeding (primary endpoint) | | style="background-color:#d73027" |Inferior cumulative weeks of platelet response without rescue therapy for bleeding (primary endpoint) | ||
|- | |- | ||
| Line 69: | Line 69: | ||
|2012-03-15 to 2014-01-02 | |2012-03-15 to 2014-01-02 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Eltrombopag_monotherapy|Eltrombopag]] | + | |[[Immune_thrombocytopenia#Eltrombopag_monotherapy|Eltrombopag]] |
| style="background-color:#d73027" |Inferior durable platelet response | | style="background-color:#d73027" |Inferior durable platelet response | ||
|- | |- | ||
| Line 75: | Line 75: | ||
|2019-12-09 to 2022-02-03 | |2019-12-09 to 2022-02-03 | ||
| style="background-color:#1a9851" |Phase 3 (C) | | style="background-color:#1a9851" |Phase 3 (C) | ||
| − | |[[#Efgartigimod_monotherapy_888|Efgartigimod]] | + | |[[Immune_thrombocytopenia#Efgartigimod_monotherapy_888|Efgartigimod]] |
| style="background-color:#fc8d59" |Seems to have inferior sustained platelet count response (primary endpoint) | | style="background-color:#fc8d59" |Seems to have inferior sustained platelet count response (primary endpoint) | ||
|- | |- | ||
Latest revision as of 23:13, 15 May 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 ITP page for regimens that include active anticancer treatment.
Relapsed or refractory
Placebo
Regimen
| Study | Dates of enrollment | Evidence | Comparator | Comparative Efficacy |
|---|---|---|---|---|
| Bussel et al. 2007 (TRA100773 phase 2) | 2005-02 to 2005-11 | Randomized Phase 2 (C) | Eltrombopag | Inferior RR |
| Kuter et al. 2008 (Amgen 20030105) | 2005-03-01 to 2006-12-31 | Phase 3 (C) | Romiplostim | Inferior durable platelet response |
| Kuter et al. 2008 (Amgen 20030212) | 2005-03-01 to 2006-12-31 | Phase 3 (C) | Romiplostim | Inferior durable platelet response |
| Bussel et al. 2009 (TRA100773) | 2006-02-06 to 2006-04-17 | Phase 3 (C) | Eltrombopag | Inferior RR |
| Ghanima et al. 2015 (RITP) | 2006-08-17 to 2011-06-30 | Phase 3 (C) | Rituximab | Did not meet primary endpoint of rate of treatment failure within 78 weeks |
| Cheng et al. 2010 (RAISE-ITP) | 2006-11-22 to 2007-07-31 | Phase 3 (C) | Eltrombopag | Inferior RR |
| Tarantino et al. 2016 (Amgen 20080279) | 2012-01-24 to 2014-09-03 | Phase 3 (C) | Romiplostim | Inferior durable platelet response |
| Jurczak et al. 2018 (E5501-G000-302) | 2012-02-06 to 2015-04-09 | Phase 3 (C) | Avatrombopag | Inferior cumulative weeks of platelet response without rescue therapy for bleeding (primary endpoint) |
| Grainger et al. 2015 (PETIT2) | 2012-03-15 to 2014-01-02 | Phase 3 (C) | Eltrombopag | Inferior durable platelet response |
| Broome et al. 2023 (ADVANCE IV) | 2019-12-09 to 2022-02-03 | Phase 3 (C) | Efgartigimod | Seems to have inferior sustained platelet count response (primary endpoint) |
No active treatment; used as a comparator arm and here for reference purposes only. Note that RAISE should not be confused with the trial by the same name in colorectal cancer.
References
- TRA100773 phase 2: Bussel JB, Cheng G, Saleh MN, Psaila B, Kovaleva L, Meddeb B, Kloczko J, Hassani H, Mayer B, Stone NL, Arning M, Provan D, Jenkins JM. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007 Nov 29;357(22):2237-47. link to original article PubMed NCT00102739
- Amgen 20030105: Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH Jr, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrère F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. link to original article PubMed NCT00102323
- Amgen 20030212: Kuter DJ, Bussel JB, Lyons RM, Pullarkat V, Gernsheimer TB, Senecal FM, Aledort LM, George JN, Kessler CM, Sanz MA, Liebman HA, Slovick FT, de Wolf JT, Bourgeois E, Guthrie TH Jr, Newland A, Wasser JS, Hamburg SI, Grande C, Lefrère F, Lichtin AE, Tarantino MD, Terebelo HR, Viallard JF, Cuevas FJ, Go RS, Henry DH, Redner RL, Rice L, Schipperus MR, Guo DM, Nichol JL. Efficacy of romiplostim in patients with chronic immune thrombocytopenic purpura: a double-blind randomised controlled trial. Lancet. 2008 Feb 2;371(9610):395-403. link to original article PubMed NCT00102336
- TRA100773: Bussel JB, Provan D, Shamsi T, Cheng G, Psaila B, Kovaleva L, Salama A, Jenkins JM, Roychowdhury D, Mayer B, Stone N, Arning M. Effect of eltrombopag on platelet counts and bleeding during treatment of chronic idiopathic thrombocytopenic purpura: a randomised, double-blind, placebo-controlled trial. Lancet. 2009 Feb 21;373(9664):641-8. link to original article PubMed NCT00102739
- RAISE-ITP: Cheng G, Saleh MN, Marcher C, Vasey S, Mayer B, Aivado M, Arning M, Stone NL, Bussel JB. Eltrombopag for management of chronic immune thrombocytopenia (RAISE): a 6-month, randomised, phase 3 study. Lancet. 2011 Jan 29;377(9763):393-402. Epub 2010 Aug 23. Erratum in: Lancet. 2011 Jan 29;377(9763):382. link to original article PubMed NCT00370331
- RITP: Ghanima W, Khelif A, Waage A, Michel M, Tjønnfjord GE, Romdhan NB, Kahrs J, Darne B, Holme PA; RITP study group. Rituximab as second-line treatment for adult immune thrombocytopenia (the RITP trial): a multicentre, randomised, double-blind, placebo-controlled trial. Lancet. 2015 Apr 25;385(9978):1653-61. Epub 2015 Feb 4. link to original article PubMed NCT00344149
- PETIT2: Grainger JD, Locatelli F, Chotsampancharoen T, Donyush E, Pongtanakul B, Komvilaisak P, Sosothikul D, Drelichman G, Sirachainan N, Holzhauer S, Lebedev V, Lemons R, Pospisilova D, Ramenghi U, Bussel JB, Bakshi KK, Iyengar M, Chan GW, Chagin KD, Theodore D, Marcello LM, Bailey CK. Eltrombopag for children with chronic immune thrombocytopenia (PETIT2): a randomised, multicentre, placebo-controlled trial. Lancet. 2015 Oct 24;386(10004):1649-58. Epub 2015 Jul 28. link to original article PubMed NCT01520909
- Amgen 20080279: Tarantino MD, Bussel JB, Blanchette VS, Despotovic J, Bennett C, Raj A, Williams B, Beam D, Morales J, Rose MJ, Carpenter N, Nie K, Eisen M. Romiplostim in children with immune thrombocytopenia: a phase 3, randomised, double-blind, placebo-controlled study. Lancet. 2016 Jul 2;388(10039):45-54. Epub 2016 Apr 18. link to original article PubMed NCT01444417
- Yang R, Li J, Jin J, Huang M, Yu Z, Xu X, Zhang X, Hou M. Multicentre, randomised phase III study of the efficacy and safety of eltrombopag in Chinese patients with chronic immune thrombocytopenia. Br J Haematol. 2017 Jan;176(1):101-110. link to original article PubMed
- E5501-G000-302: Jurczak W, Chojnowski K, Mayer J, Krawczyk K, Jamieson BD, Tian W, Allen LF. Phase 3 randomised study of avatrombopag, a novel thrombopoietin receptor agonist for the treatment of chronic immune thrombocytopenia. Br J Haematol. 2018 Nov;183(3):479-490. Epub 2018 Sep 7. link to original article link to PMC article PubMed NCT01438840
- ADVANCE IV: Broome CM, McDonald V, Miyakawa Y, Carpenedo M, Kuter DJ, Al-Samkari H, Bussel JB, Godar M, Ayguasanosa J, De Beuf K, Rodeghiero F, Michel M, Newland A; ADVANCE Investigator Study Group. Efficacy and safety of the neonatal Fc receptor inhibitor efgartigimod in adults with primary immune thrombocytopenia (ADVANCE IV): a multicentre, randomised, placebo-controlled, phase 3 trial. Lancet. 2023 Nov 4;402(10413):1648-1659. Epub 2023 Sep 28. link to original article PubMed NCT04188379