Chronic myelomonocytic leukemia

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Section editor
	Sanjay R. Mohan, MD, MSCI 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

• NCCN Guidelines - Myelodysplastic Syndromes

First-line therapy

Azacitidine monotherapy

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Variant #1, 7 days

Study	Evidence	Comparator	Efficacy
Sekeres et al. 2017 (SWOG S1117)	Randomized Phase II, <20 pts in subgroup	Azacitidine & Lenalidomide	Seems not superior
		Azacitidine & Vorinostat	Seems not superior

Chemotherapy

• Azacitidine (Vidaza) 75 mg/m² SC/IV once per day on days 1 to 7

28-day cycles

Variant #2, 5-2-2

Study	Evidence	Comparator	Efficacy
Drummond et al. 2014	Phase II
Sekeres et al. 2017 (SWOG S1117)	Randomized Phase II, <20 pts in subgroup	Azacitidine & Lenalidomide	Seems not superior
		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, then continued for responders or SD until progression or intolerance.

References

1. 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 verified protocol PubMed
2. 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 verified protocol PubMed

Azacitidine & Lenalidomide

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Variant #1, 7 days of azacitidine

Study	Evidence	Comparator	Efficacy
Sekeres et al. 2017 (SWOG S1117)	Randomized Phase II, <20 pts in subgroup	Azacitidine	Seems not superior
		Azacitidine & Vorinostat	Not reported

Chemotherapy

• Azacitidine (Vidaza) 75 mg/m² SC/IV once per day on days 1 to 7
• Lenalidomide (Revlimid) 10 mg PO once per day on days 1 to 21

28-day cycles

Variant #2, 5-2-2 azacitidine

Study	Evidence	Comparator	Efficacy
Sekeres et al. 2017 (SWOG S1117)	Randomized Phase II, <20 pts in subgroup	Azacitidine	Seems not superior
		Azacitidine & Vorinostat	Not reported

Chemotherapy

• Azacitidine (Vidaza) 75 mg/m² SC/IV once per day on days 1 to 5, 8 & 9
• Lenalidomide (Revlimid) 10 mg PO once per day on days 1 to 21

28-day cycles

References

1. 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 verified protocol PubMed

Azacitidine & Vorinostat

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Variant #1, 7 days of azacitidine

Study	Evidence	Comparator	Efficacy
Sekeres et al. 2017 (SWOG S1117)	Randomized Phase II, <20 pts in subgroup	Azacitidine	Seems not superior
		Azacitidine & Lenalidomide	Not reported

Chemotherapy

• Azacitidine (Vidaza) 75 mg/m² SC/IV once per day on days 1 to 7
• Vorinostat (Zolinza) 300 mg PO BID on days 3 to 9

28-day cycles

Variant #2, 5-2-2 azacitidine

Study	Evidence	Comparator	Efficacy
Sekeres et al. 2017 (SWOG S1117)	Randomized Phase II, <20 pts in subgroup	Azacitidine	Seems not superior
		Azacitidine & Lenalidomide	Not reported

Chemotherapy

• Azacitidine (Vidaza) 75 mg/m² SC/IV once per day on days 1 to 5, 8 & 9
• Vorinostat (Zolinza) 300 mg PO BID on days 3 to 9

28-day cycles

References

1. 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 verified protocol PubMed

Decitabine monotherapy

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Regimen

Study	Evidence	Efficacy
Santini et al. 2017	Phase II	ORR: 48%

Chemotherapy

• Decitabine (Dacogen) 20 mg/m² IV once per day on days 1 to 5

28-day cycles

References

1. 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 verified protocol PubMed

Maintenance after first-line therapy

Azacitidine monotherapy

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Regimen

Study	Evidence
Grövdal et al. 2010	Phase II

Chemotherapy

• Azacitidine (Vidaza) 60 mg/m² SC once per day on days 1 to 5

28-day cycles

References

1. 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 verified protocol PubMed content property of HemOnc.org