SWOG clinical trial number
E1905

A Randomized Phase II Trial of Azacitidine With or Without the Histone Deacetylase Inhibitor MS-275 for the Treatment of Myelodysplastic Syndrome, Chronic Myelomonocytic Leukemia (Dysplastic Type), and Acute Myeloid Leukemia with Multilineage Dysplasia

Closed
Phase
Published
Abbreviated Title
Phase II Azacitidine +/- MS-275 for MDS, CML (Dysplastic), and AML with Multilineage Dysplasia
Activated
10/01/2006
Participants
NCORP, Members, Medical Oncologists, Pathologists, Affiliates

Research committees

Leukemia

Treatment

Azacitidine MS-275

Eligibility Criteria Expand/Collapse

Pt must have either MDS, CML (Dysplastic subtype), or AML with multilineage dysplasia. Pt must be >/= 18 years old. Women must not be pregnant or breastfeeding. All females of childbearing potential must have a blood test or urine study within two weeks prior to registration to rule out pregnancy. Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception. ECOG PS 0-2. Pt must have no prior treatment with azacitidine, decitabine or entinostat. Pt must not have active infections at the time of registration. Pt must have a serum creatinine of < 2.0 mg/dL within 7 days prior to registration. Pt must have total serum bilirubin within institutional limits unless due to intra- or extramedullary hemolysis or Gilbert's syndrome within 7 days prior to registration. Pt may have AST(SGOT) and ALT(SGPT) </= 2.5 x IULN within 7 days prior to registration. Pts who have therapy-induced MDS, CML (dysplastic) and AML-TLD are eligible for the treatment related cohort. (As of the re-activation of this study, only patients with treatment-related disease are eligible for enrollment.) Pt must have no clinical evidence of CNS or pulmonary leukostasis, disseminated intravascular coagulation, or CNS leukemia. Pt must have no serious or uncontrolled medical conditions. Pts should have a life expectancy of at least 6 months. Pts must not have advanced malignant hepatic tumors. Pts must not have a known hypersensitivity to azacitidine or mannitol.

Publication Information Expand/Collapse

2016

Azacitidine with or without entinostat for the treatment of therapy-related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study

T Prebet;Z Sun;R Ketterling;A Zeidan;P Greenberg;J Herman;M Juckett;MR Smith;L Malick;E Paietta;M Czader;M Figueroa;J Gabrilove;H Erba;M Tallman;M Litzow;S Gore British Journal of Haematology, Feb;172(3):384-391

PMid: PMID26577691 | PMC number: PMC4794257

2014

Prolonged administration of azacitidine with or without entinostat for myelodysplastic syndrome and acute myeloid leukemia and myelodysplasia-related changes: results of the US Leukemia Intergroup trial E1905

T Prebet;Z Sun;ME Figueroa;R Ketterling;A Melnick;P Greenberg;M Juckett;M Smith;L Malick;E Paietta;M Czader;J Gabrilove;H Erba;S Gore;M Tallman Journal of Clinical Oncology 32(12):1242-2348;

PMid: PMID24663049 | PMC number: PMC3986386

Comparison of the prognostic utility of the revised International Prognostic Scoring System and the French Prognostic Scoring System in azacitidine-treated patients with myelodysplastic syndromes

A Zeidan;J-W Lee;T Prebet;P Greenberg;Z Sun;M Juckett;MR Smith;E Paietta;J Gabrilove;HP Erba;MS Tallman;SD Gore British Journal of Haematology 166(3):352-359

PMid: PMID24712482 | PMC number: PMC4299460

Platelet count doubling after the first cycle of azacitidine therapy predicts eventual response and survival in patients with myelodysplastic syndromes and oligoblastic acute myeloid leukaemia but does not add to prognostic utility of the revised IPSS

A Zeidan;JW Lee;T Prebet;P Greenberg;Z Sun;M Juckett;MR Smith;E Paietta;J Gabrilove;HP Erba;RP Katterling;MS Tallman;SD Gore British Journal of Haematology 167(1):62-68;

PMid: PMID24995683 | PMC number: PMC4299466

2013

Azacitidine with our without entinostat for the treatment of therapy related myeloid neoplasm: further results of the E1905 North American Leukemia Intergroup study

T Prebet;Z Sun;R Ketterling;P Greenberg;A Zeidan;M Litzow;J Gabriolove;H Erba;E Paietta;M Czader;SD Gord;M Tallman Blood 122:3924, ASH annual meeting, poster presentation;

2010

Prolonged administration of Azacitidine with or without Entinostat increases rate of hematologic normalization for myelodysplastic syndrome and acute myeloid leukemia with trilineage cysplasia: results of the E1905 trial

T Prebet;S Gore;Z Sun;P Greenberg;M Juckett;L Malick;M Smith;E Paietta;M Czader;J Gabrilove;H Erba;M Tallman Blood 116:abst.#1038; American Society of Hematology 2010 Annual Meeting; oral

A 10 day schedule of azacitidine induces more complete cytogenetic remissions than the standard schedule: results of the E1905 study

T Prebet;Z Sun;R Ketterling;G Hicks;CL Beach;P Greenberg;E Paietta;M Czader;J Gabrilove;H Erba;M Tallman;S Gore Blood 116:abst. #601; American Society of Hematology 2010 Annual Meeting; oral

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