Chronic myelomonocytic leukemia

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Note: many trials consider CMML to be a subtype of MDS; please check the MDS page for additional relevant studies.
Last updated on 2024-07-23:7 regimens on this page
10 variants on this page
=Guidelines=
Given the rapid change in evidence in many areas of hematology/oncology, readers are encouraged to consider any guideline published 5+ years ago to be for historical purposes, only.
==EBMT==
*2024: Management of adult patients with CMML undergoing allo-HCT: recommendations from the EBMT PH&G Committee EuroPMC
==International expert panel==
*2017: Allogeneic hematopoietic stem cell transplantation for MDS and CMML: recommendations from an international expert panel link to PMC article EuroPMC
==NCCN==
*NCCN does not currently have guidelines at this granular level; please see NCCN Guidelines - Myelodysplastic Syndromes.
=First-line therapy=
==Azacitidine monotherapy==
===Regimen variant #1, 7 days===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (C)	1. Azacitidine & Lenalidomide	Seems to have lower ORR
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (C)	2. Azacitidine & Vorinostat 	Did not meet primary endpoint of ORR
====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 	Dates 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, fewer than 20 pts in subgroup (C)	1. Azacitidine & Lenalidomide	Seems to have lower ORR
Sekeres et al. 2017 (SWOG S1117) 	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (C)	2. Azacitidine & Vorinostat 	Did not meet primary endpoint of ORR
Adès et al. 2022 (PANTHERMDS) 	2017-2019 	Phase 3 (C) 	Azacitidine & Pevonedistat 	Did not meet primary endpoint of EFS
====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 dosing details in manuscript have been reviewed by our editors EuroPMC 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 dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT01522976
# PANTHERMDS: Adès L, Girshova L, Doronin VA, Díez-Campelo M, Valcárcel D, Kambhampati S, Viniou NA, Woszczyk D, De Paz Arias R, Symeonidis A, Anagnostopoulos A, Munhoz EC, Platzbecker U, Santini V, Fram RJ, Yuan Y, Friedlander S, Faller DV, Sekeres MA. Pevonedistat plus azacitidine vs azacitidine alone in higher-risk MDS/chronic myelomonocytic leukemia or low-blast-percentage AML. Blood Adv. 2022 Sep 13;6(17):5132-5145. link to original article dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT03268954
==Azacitidine & Lenalidomide==
===Regimen variant #1, 7 days of azacitidine===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (E-esc)	1. Azacitidine 	Seems to have higher ORR (primary endpoint)
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (E-esc)	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 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (E-esc)	1. Azacitidine 	Seems to have higher ORR (primary endpoint)
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (E-esc)	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 dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT01522976
==Azacitidine & Vorinostat==
===Regimen variant #1, 7 days of azacitidine===
Study 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (E-esc)	1. Azacitidine 	Did not meet primary endpoint of ORR
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (E-esc)	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 	Dates of enrollment	Evidence 	Comparator 	Comparative Efficacy
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (E-esc)	1. Azacitidine 	Did not meet primary endpoint of ORR
Sekeres et al. 2017 (SWOG S1117)	2012-2014 	Randomized Phase 2, fewer than 20 pts in subgroup (E-esc)	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 dosing details in manuscript have been reviewed by our editors link to PMC article EuroPMC NCT01522976
==Decitabine monotherapy==
===Regimen===
Study 	Dates of enrollment 	Evidence 	Comparator 	Comparative Efficacy
Santini et al. 2017 (DECI2009) 	2010-04 to 2011-10 	Phase 2 	 	ORR: 48%
Garcia-Manero et al. 2020 (ASTX727-01-B)	2014 to not reported	Randomized Phase 2, fewer than 20 pts in this subgroup (C)	Oral decitabine	Not reported
Itzykson et al. 2023 (DACOTA) 	2014-10 to 2019-09 	Phase 3 (E-switch-ooc) 	Hydroxyurea 	Did not meet primary endpoint of EFS
Note: ASTX727-01-B was a randomized crossover trial examining PK/PD, and was not designed to compare efficacy.
====Chemotherapy====
*Decitabine (Dacogen) 20 mg/m2 IV over 60 minutes once per day on days 1 to 5
28-day cycles
===References===
#DECI2009: 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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT01251627
#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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT02103478
#DACOTA: Itzykson R, Santini V, Thepot S, Ades L, Chaffaut C, Giagounidis A, Morabito M, Droin N, Luebbert M, Sapena R, Nimubona S, Goasguen J, Wattel E, Zini G, Torregrosa Diaz JM, Germing U, Pelizzari AM, Park S, Jaekel N, Metzgeroth G, Onida F, Navarro R, Patriarca A, Stamatoullas A, Goetze K, Puttrich M, Mossuto S, Solary E, Gloaguen S, Chevret S, Chermat F, Platzbecker U, Fenaux P. Decitabine Versus Hydroxyurea for Advanced Proliferative Chronic Myelomonocytic Leukemia: Results of a Randomized Phase III Trial Within the EMSCO Network. J Clin Oncol. 2023 Apr 1;41(10):1888-1897. Epub 2022 Dec 1. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02214407
==Decitabine and cedazuridine monotherapy==
===Regimen===
FDA-recommended dose
Study 	Dates of enrollment 	Evidence 	Comparator	Comparative Efficacy
Garcia-Manero et al. 2020 (ASTX727-01-B)	2014 to not reported	Randomized Phase 2, fewer than 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 dosing details in manuscript have been reviewed by our editors EuroPMC NCT02103478
==Hydroxyurea monotherapy==
===Regimen===
Study 	Dates of enrollment	Evidence 	Comparator	Comparative Efficacy
Itzykson et al. 2023 (DACOTA)	2014-10 to 2019-09 	Phase 3 (C)	Decitabine	Did not meet primary endpoint of EFS
====Chemotherapy====
*Hydroxyurea (Hydrea) 1000 to 4000 mg/day PO
28-day cycles
===References===
#DACOTA: Itzykson R, Santini V, Thepot S, Ades L, Chaffaut C, Giagounidis A, Morabito M, Droin N, Luebbert M, Sapena R, Nimubona S, Goasguen J, Wattel E, Zini G, Torregrosa Diaz JM, Germing U, Pelizzari AM, Park S, Jaekel N, Metzgeroth G, Onida F, Navarro R, Patriarca A, Stamatoullas A, Goetze K, Puttrich M, Mossuto S, Solary E, Gloaguen S, Chevret S, Chermat F, Platzbecker U, Fenaux P. Decitabine Versus Hydroxyurea for Advanced Proliferative Chronic Myelomonocytic Leukemia: Results of a Randomized Phase III Trial Within the EMSCO Network. J Clin Oncol. 2023 Apr 1;41(10):1888-1897. Epub 2022 Dec 1. link to original article dosing details in manuscript have been reviewed by our editors EuroPMC NCT02214407
=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 dosing details in manuscript have been reviewed by our editors EuroPMC content property of HemOnc.org
Category:Chronic myelomonocytic leukemia regimens
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Category:Myeloproliferative neoplasms