Difference between revisions of "Chronic myelomonocytic leukemia"
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===References=== | ===References=== | ||
− | # '''CTRU-CMML-201:''' Drummond MW, Pocock C, Boissinot M, Mills J, Brown J, Cauchy P, Cross NC, Hartley S, Kell J, Szubert A, Cockerill PN, Bowen DT. A multi-centre phase 2 study of azacitidine in chronic myelomonocytic leukaemia. Leukemia. 2014 Jul;28(7):1570-2. Epub 2014 Feb 26. [https://doi.org/10.1038/leu.2014.85 link to original article] '''contains | + | # '''CTRU-CMML-201:''' Drummond MW, Pocock C, Boissinot M, Mills J, Brown J, Cauchy P, Cross NC, Hartley S, Kell J, Szubert A, Cockerill PN, Bowen DT. A multi-centre phase 2 study of azacitidine in chronic myelomonocytic leukaemia. Leukemia. 2014 Jul;28(7):1570-2. Epub 2014 Feb 26. [https://doi.org/10.1038/leu.2014.85 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/24569776 PubMed] NCT01235117 |
− | # '''SWOG S1117:''' Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. [https://doi.org/10.1200/JCO.2015.66.2510 link to original article] '''contains | + | # '''SWOG S1117:''' Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. [https://doi.org/10.1200/JCO.2015.66.2510 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28486043 PubMed] NCT01522976 |
# '''PANTHER:''' NCT03268954 | # '''PANTHER:''' NCT03268954 | ||
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===References=== | ===References=== | ||
− | # '''SWOG S1117:''' Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. [https://doi.org/10.1200/JCO.2015.66.2510 link to original article] '''contains | + | # '''SWOG S1117:''' Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. [https://doi.org/10.1200/JCO.2015.66.2510 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28486043 PubMed] NCT01522976 |
==Azacitidine & Vorinostat {{#subobject:a816bd|Regimen=1}}== | ==Azacitidine & Vorinostat {{#subobject:a816bd|Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # '''SWOG S1117:''' Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. [https://doi.org/10.1200/JCO.2015.66.2510 link to original article] '''contains | + | # '''SWOG S1117:''' Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. [https://doi.org/10.1200/JCO.2015.66.2510 link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28486043 PubMed] NCT01522976 |
==Decitabine monotherapy {{#subobject:c9cd47|Regimen=1}}== | ==Decitabine monotherapy {{#subobject:c9cd47|Regimen=1}}== | ||
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===References=== | ===References=== | ||
− | # Santini V, Allione B, Zini G, Gioia D, Lunghi M, Poloni A, Cilloni D, Sanna A, Masiera E, Ceccarelli M, Abdel-Wahab O, Terenzi A, Angelucci E, Finelli C, Onida F, Pelizzari A, Ferrero D, Saglio G, Figueroa M, Levis A. A phase II, multicentre trial of decitabine in higher-risk chronic myelomonocytic leukemia. Leukemia. 2018 Feb;32(2):413-418. Epub 2017 Jun 13. [https://www.nature.com/articles/leu2017186 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808077/ link to PMC article] '''contains | + | # Santini V, Allione B, Zini G, Gioia D, Lunghi M, Poloni A, Cilloni D, Sanna A, Masiera E, Ceccarelli M, Abdel-Wahab O, Terenzi A, Angelucci E, Finelli C, Onida F, Pelizzari A, Ferrero D, Saglio G, Figueroa M, Levis A. A phase II, multicentre trial of decitabine in higher-risk chronic myelomonocytic leukemia. Leukemia. 2018 Feb;32(2):413-418. Epub 2017 Jun 13. [https://www.nature.com/articles/leu2017186 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5808077/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/28607470 PubMed] |
=Maintenance after first-line therapy= | =Maintenance after first-line therapy= | ||
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===References=== | ===References=== | ||
− | # Grövdal M, Karimi M, Khan R, Aggerholm A, Antunovic P, Astermark J, Bernell P, Engström LM, Kjeldsen L, Linder O, Nilsson L, Olsson A, Holm MS, Tangen JM, Wallvik J, Oberg G, Hokland P, Jacobsen SE, Porwit A, Hellström-Lindberg E. Maintenance treatment with azacytidine for patients with high-risk myelodysplastic syndromes (MDS) or acute myeloid leukaemia following MDS in complete remission after induction chemotherapy. Br J Haematol. 2010 Aug;150(3):293-302. Epub 2010 May 20. [https://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2010.08235.x/full link to original article] '''contains | + | # Grövdal M, Karimi M, Khan R, Aggerholm A, Antunovic P, Astermark J, Bernell P, Engström LM, Kjeldsen L, Linder O, Nilsson L, Olsson A, Holm MS, Tangen JM, Wallvik J, Oberg G, Hokland P, Jacobsen SE, Porwit A, Hellström-Lindberg E. Maintenance treatment with azacytidine for patients with high-risk myelodysplastic syndromes (MDS) or acute myeloid leukaemia following MDS in complete remission after induction chemotherapy. Br J Haematol. 2010 Aug;150(3):293-302. Epub 2010 May 20. [https://onlinelibrary.wiley.com/doi/10.1111/j.1365-2141.2010.08235.x/full link to original article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/20497178 PubMed] content property of [http://hemonc.org HemOnc.org] |
==Decitabine and cedazuridine monotherapy {{#subobject:c98ugac|Regimen=1}}== | ==Decitabine and cedazuridine monotherapy {{#subobject:c98ugac|Regimen=1}}== | ||
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'''28-day cycles''' | '''28-day cycles''' | ||
===References=== | ===References=== | ||
− | #'''ASTX727-01-B:''' Garcia-Manero G, Griffiths EA, Steensma DP, Roboz GJ, Wells R, McCloskey J, Odenike O, DeZern AE, Yee K, Busque L, O'Connell C, Michaelis LC, Brandwein J, Kantarjian H, Oganesian A, Azab M, Savona MR. Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study. Blood. 2020 Aug 6;136(6):674-683. [https://doi.org/10.1182/blood.2019004143 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7414597/ link to PMC article] '''contains | + | #'''ASTX727-01-B:''' Garcia-Manero G, Griffiths EA, Steensma DP, Roboz GJ, Wells R, McCloskey J, Odenike O, DeZern AE, Yee K, Busque L, O'Connell C, Michaelis LC, Brandwein J, Kantarjian H, Oganesian A, Azab M, Savona MR. Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study. Blood. 2020 Aug 6;136(6):674-683. [https://doi.org/10.1182/blood.2019004143 link to original article] [https://www.ncbi.nlm.nih.gov/pmc/articles/pmc7414597/ link to PMC article] '''contains dosing details in manuscript''' [https://pubmed.ncbi.nlm.nih.gov/32285126 PubMed] NCT02103478 |
[[Category:Chronic myelomonocytic leukemia regimens]] | [[Category:Chronic myelomonocytic leukemia regimens]] | ||
[[Category:Disease-specific pages]] | [[Category:Disease-specific pages]] | ||
[[Category:Myeloproliferative neoplasms]] | [[Category:Myeloproliferative neoplasms]] |
Revision as of 12:56, 29 August 2022
Section editor | |
---|---|
Sanjay R. Mohan, MD, MSCI Vanderbilt University Nashville, TN |
7 regimens on this page
10 variants on this page
|
Guidelines
International expert panel
- Allogeneic hematopoietic stem cell transplantation for MDS and CMML: recommendations from an international expert panel. (2017) PubMed
NCCN
First-line therapy
Azacitidine monotherapy
Regimen variant #1, 7 days
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Sekeres et al. 2017 (SWOG S1117) | 2012-2014 | Randomized Phase 2, <20 pts in subgroup (C) | 1. Azacitidine & Lenalidomide | Seems not superior |
2. Azacitidine & Vorinostat | Seems not superior |
Chemotherapy
- Azacitidine (Vidaza) 75 mg/m2 IV or SC once per day on days 1 to 7
28-day cycles
Regimen variant #2, 5-2-2
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Drummond et al. 2014 (CTRU-CMML-201) | 2010 | Phase 2 | ||
Sekeres et al. 2017 (SWOG S1117) | 2012-2014 | Randomized Phase 2, <20 pts in subgroup (C) | 1. Azacitidine & Lenalidomide | Seems not superior |
2. Azacitidine & Vorinostat | Seems not superior |
Chemotherapy
- Azacitidine (Vidaza) 75 mg/m2 IV once per day on days 1 to 5, 8 & 9
28-day cycle for at least 6 cycles
References
- CTRU-CMML-201: Drummond MW, Pocock C, Boissinot M, Mills J, Brown J, Cauchy P, Cross NC, Hartley S, Kell J, Szubert A, Cockerill PN, Bowen DT. A multi-centre phase 2 study of azacitidine in chronic myelomonocytic leukaemia. Leukemia. 2014 Jul;28(7):1570-2. Epub 2014 Feb 26. link to original article contains dosing details in manuscript PubMed NCT01235117
- SWOG S1117: Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. link to original article contains dosing details in manuscript PubMed NCT01522976
- PANTHER: NCT03268954
Azacitidine & Lenalidomide
Regimen variant #1, 7 days of azacitidine
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Sekeres et al. 2017 (SWOG S1117) | 2012-2014 | Randomized Phase 2, <20 pts in subgroup (E-esc) | 1. Azacitidine | Seems not superior |
2. Azacitidine & Vorinostat | Not reported |
Chemotherapy
- Azacitidine (Vidaza) 75 mg/m2 IV or SC once per day on days 1 to 7
Targeted therapy
- Lenalidomide (Revlimid) 10 mg PO once per day on days 1 to 21
28-day cycles
Regimen variant #2, 5-2-2 azacitidine
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Sekeres et al. 2017 (SWOG S1117) | 2012-2014 | Randomized Phase 2, <20 pts in subgroup (E-esc) | 1. Azacitidine | Seems not superior |
2. Azacitidine & Vorinostat | Not reported |
Chemotherapy
- Azacitidine (Vidaza) 75 mg/m2 IV or SC once per day on days 1 to 5, 8 & 9
Targeted therapy
- Lenalidomide (Revlimid) 10 mg PO once per day on days 1 to 21
28-day cycles
References
- SWOG S1117: Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. link to original article contains dosing details in manuscript PubMed NCT01522976
Azacitidine & Vorinostat
Regimen variant #1, 7 days of azacitidine
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Sekeres et al. 2017 (SWOG S1117) | 2012-2014 | Randomized Phase 2, <20 pts in subgroup (E-esc) | 1. Azacitidine | Seems not superior |
2. Azacitidine & Lenalidomide | Not reported |
Chemotherapy
- Azacitidine (Vidaza) 75 mg/m2 IV or SC once per day on days 1 to 7
Targeted therapy
- Vorinostat (Zolinza) 300 mg PO twice per day on days 3 to 9
28-day cycles
Regimen variant #2, 5-2-2 azacitidine
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Sekeres et al. 2017 (SWOG S1117) | 2012-2014 | Randomized Phase 2, <20 pts in subgroup (E-esc) | 1. Azacitidine | Seems not superior |
2. Azacitidine & Lenalidomide | Not reported |
Chemotherapy
- Azacitidine (Vidaza) 75 mg/m2 IV or SC once per day on days 1 to 5, 8 & 9
Targeted therapy
- Vorinostat (Zolinza) 300 mg PO twice per day on days 3 to 9
28-day cycles
References
- SWOG S1117: Sekeres MA, Othus M, List AF, Odenike O, Stone RM, Gore SD, Litzow MR, Buckstein R, Fang M, Roulston D, Bloomfield CD, Moseley A, Nazha A, Zhang Y, Velasco MR, Gaur R, Atallah E, Attar EC, Cook EK, Cull AH, Rauh MJ, Appelbaum FR, Erba HP. Randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat in higher-risk myelodysplastic syndromes and chronic myelomonocytic leukemia: North American Intergroup Study SWOG S1117. J Clin Oncol. 2017 Aug 20;35(24):2745-2753. Epub 2017 May 9. link to original article contains dosing details in manuscript PubMed NCT01522976
Decitabine monotherapy
Regimen
Study | Evidence | Efficacy |
---|---|---|
Santini et al. 2017 | Phase 2 | ORR: 48% |
Chemotherapy
- Decitabine (Dacogen) 20 mg/m2 IV once per day on days 1 to 5
28-day cycles
References
- Santini V, Allione B, Zini G, Gioia D, Lunghi M, Poloni A, Cilloni D, Sanna A, Masiera E, Ceccarelli M, Abdel-Wahab O, Terenzi A, Angelucci E, Finelli C, Onida F, Pelizzari A, Ferrero D, Saglio G, Figueroa M, Levis A. A phase II, multicentre trial of decitabine in higher-risk chronic myelomonocytic leukemia. Leukemia. 2018 Feb;32(2):413-418. Epub 2017 Jun 13. link to original article link to PMC article contains dosing details in manuscript PubMed
Maintenance after first-line therapy
Azacitidine monotherapy
Regimen
Study | Evidence |
---|---|
Grövdal et al. 2010 | Phase 2 |
Chemotherapy
- Azacitidine (Vidaza) 60 mg/m2 SC once per day on days 1 to 5
28-day cycles
References
- Grövdal M, Karimi M, Khan R, Aggerholm A, Antunovic P, Astermark J, Bernell P, Engström LM, Kjeldsen L, Linder O, Nilsson L, Olsson A, Holm MS, Tangen JM, Wallvik J, Oberg G, Hokland P, Jacobsen SE, Porwit A, Hellström-Lindberg E. Maintenance treatment with azacytidine for patients with high-risk myelodysplastic syndromes (MDS) or acute myeloid leukaemia following MDS in complete remission after induction chemotherapy. Br J Haematol. 2010 Aug;150(3):293-302. Epub 2010 May 20. link to original article contains dosing details in manuscript PubMed content property of HemOnc.org
Decitabine and cedazuridine monotherapy
Regimen
FDA-recommended dose |
Study | Years of enrollment | Evidence | Comparator | Comparative Efficacy |
---|---|---|---|---|
Garcia-Manero et al. 2020 (ASTX727-01-B) | 2014-NR | Randomized Phase 2, <20 pts in this subgroup (E-RT-switch-ic) | Decitabine | Not reported |
Note: this was a randomized crossover trial examining PK/PD, and was not designed to compare efficacy.
Chemotherapy
- Decitabine and cedazuridine (Inqovi) 35/100 mg PO once per day on days 1 to 5
28-day cycles
References
- ASTX727-01-B: Garcia-Manero G, Griffiths EA, Steensma DP, Roboz GJ, Wells R, McCloskey J, Odenike O, DeZern AE, Yee K, Busque L, O'Connell C, Michaelis LC, Brandwein J, Kantarjian H, Oganesian A, Azab M, Savona MR. Oral cedazuridine/decitabine for MDS and CMML: a phase 2 pharmacokinetic/pharmacodynamic randomized crossover study. Blood. 2020 Aug 6;136(6):674-683. link to original article link to PMC article contains dosing details in manuscript PubMed NCT02103478