SWOG clinical trial number
S0703

A Phase II Trial of Azacitidine Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia

Closed
Phase
II
Accrual
93%
Published
Abbreviated Title
Phase II Older Previously Untreated Non-M3 AML
Status Notes
Activated
12/01/2008
Participants
NCORP, Members, Medical Oncologists, Pathologists, Affiliates

Research committees

Leukemia

Treatment

Hydroxyurea Azacitidine Gemtuzumab Ozogamicin

Eligibility Criteria Expand/Collapse

Pts must have a morphologically confirmed diagnosis of AML per the protocol. Pts must have Zubrod performance status of 0-3. Pts must not have known hypersensitivity to azacitidine, mannitol, hydroxyurea or gemtuzumab ozogamicin. Pts must be at least 60 yrs old. Pts must not have received prior systemic chemotherapy for acute leukemia (except of hydroxyurea; administration of hydroxyurea to control high WBC count prior to registration is permitted). Pts with a history of prior MDS are eligible, however, prior treatment of MDS with AML induction-type chemotherapy or high dose chemotherapy with hematopoietic stem cell support is not allowed. Pts may have received hematopoietic growth factors, thalidomide, lenalidomide, arsenic trioxide, signal transduction inhibitors and low dose cytarabine for treatment of myelodysplastic syndrome, however, the dose of cytarabine must be < 100 mg/m2/day. Pts with previous therapy with azacitidine, decitabine and gemtuzumab ozogamicin (Mylotarg®) are not eligible. Pts must be off prior therapy for MDS at least 30 days prior to study registration; all toxicities must have resolved. Pts must have a bilirubin </= 2.0 x Institutional Upper Limit of Normal (IULN) within 14 days prior to registration, unless the elevation is believed to be due to hepatic infiltration by AML; hyperbilirubinemia due primarily to elevated unconjugated hyperbilirubinemia secondary to Gilbert's syndrome or hemolysis is allowed. Pts must have SGOT (AST) </= 2.0 x IULN, or SGPT (ALT) </= 2.0 x IULN, or both within 14 days prior to registration, unless the elevation is believed to be due to hepatic infiltration by AML. (If both tests are performed they should both be within the specified limits.) Pts must have a serum creatinine </= 1.5 x IULN within 14 days prior to registration. Pts must have an adequate cardiac function with left ventricular ejection fraction of >/= 40% (as determined by either MUGA or ECG) and no clinical evidence of congestive heart failure within 56 days prior to registration. Pts must have specimens submitted for cytogenetics. Pts must submit specimens for cellular and molecular studies and be offered participation in banking. Pts must not have CNS involvement. If central nervous involvement is clinically suspected, it must be ruled out by a lumbar puncture. Women of reproductive potential must have a pregnancy test within 28 days prior to registration. Pts must not be pregnant or nursing. Women/men of reproductive potential must have agreed to use an effective contraceptive method. Pts not known to be HIV+ must be tested for HIV infection within 14 days prior to registration. Pts who are HIV+ may be eligible providing: they have no history of AIDS defining events, CD4 cells >/= 500/mm3, viral load < 50 copies HIV mRNA/mm3 if on cART or < 25,000 copies HIV mRNA if not on cART and no zidovudine or stavudine as part of cART. Pts must not have prior malignancy except: a) adequately treated basal cell or squamous cell skin cancer, or b) any diagnosis of malignancy made at least 2 years earlier, of which there is no clinically evident cancer, and for which the patient has completed all chemotherapy and radiotherapy at least 6 months prior to registration. Prior treatment with AML induction-type chemotherapy is not allowed. Concurrent hormonal therapy is allowed.

Publication Information Expand/Collapse

2019

Relative survival following response to 7+3 versus azacytidine is similar in acute myeloid leukemia and high-risk myelodysplastic syndromes: An analysis of four SWOG studies

M Othus;M Sekeres;S Nand;G Garcia-Manero;F Appelbaum;HP Erba;E Estey Leukemia Feb;33(2):371-378; Oct 12. doi: 10.1038/s41375-018-0275-x. [Epub ahead of print]

PMid: PMID30315234 | PMC number: PMC6367029

Allogeneic Hematopoietic Cell Transplantation Compared to Chemotherapy Consolidation in older Acute Myeloid Leukemia (AML) Patients 60-75 Years in First Complete Remission (CR1): An Alliance (A151509), SWOG, ECOG-ACRIN and CIBMTR Study

C Ustun;J Le-Rademacher;H-L Wang;M Othus;Z Sun;B Major;M-J Zhang;E Storrick;J Lafky;S Chow;K Mrozek;E Attar;C Bloomfield;L Cripe;M Tallman;F Appelbaum;S Nand;R Larson;G Marcucci;G Roboz;GL Uy;RM Stone;A Jatoi;T Shea;M di Lima;J Foran;B Sandmaier;M Litzow;H Erba;A Hurria;D Weisdorf;A Artz Leukemia 2019 May 9. doi: 10.1038/s41375-019-0477-x. [Epub ahead of print]

PMid: PMID31073153

2018

Comparable Outcomes of Patients Eligible versus Ineligible for SWOG Leukemia Studies

A Statler;M Othus;H Erba;T Chauncey;J Radich;S Coutre;A Advani;S Nand;F Ravandi;S Mukherjee;M Sekeres Blood Jun 21;131(25):2782-2788; Apr 4 [Epub ahead of print]

PMid: PMID29618479 | PMC number: PMC6014358

2016

Association between early DNA methylation changes and outcome in older patients with acute myeloid leukemia treated on SWOG S0703

N Achille;M Othus;K Phelan;S Zhang;K Cooper;J Godwin;F Appelbaum;J Radich;H Erba;S Nand;N Zeleznik-Le Leukemia Research Mar;42:68-74

PMid: PMID26818573 | PMC number: PMC4779662

Relation between event-free survival and overall survival in acute myeloid leukemia: A report from SWOG, HOVN/SAKK, and MRC/NCRI

M Othus;W van Putten;B Lowenberg;S Petersdorf;S Nand;H Erba;F Appelbaum;R Hills;N Russell;A Burnett;E Estey Haematologica Jul;101(7):e284-286; 2016 Mar 24 [Epub ahead of print]

PMid: PMID27013652 | PMC number: PMC5004473

Complete remissions (CRs) with azacitidine regimens compared to CRs with 7+3 induction chemotherapy and the effect on overall survival

M Othus;M Sekeres;S Nand;G Garcia-Manero;F Appelbaum;H Erba;E Estey Blood 128:1613; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), poster

Comparable outcomes of patients eligible versus ineligible for SWOG leukemia studies

A Statler;M Othus;H Erba;T Chauncey;J Radich;S Coutre;A Advani;S Nand;F Ravandi;S Mukherjee;M Sekeres Blood 128:4002; American Society of Hematology Annual Meeting (December 3-6, 2016, San Diego, CA), poster

2015

Association between early promoter-specific DNA methylation changes and outcome in older acute myeloid leukemia patients treated on SWOG S0703 (NCT00658814)

S Nand;N Achille;M Othus;K Phelan;S Zhang;K Cooper;J Godwin;F Appelbaum;J Radich;H Erba;N Zeleznik-Le Journal of Clinical Oncology J Clin Oncol 33:5s (suppl; abstr 7060); American Society of Clinical Oncology Annual Meeting (May 29-June 2, 2015, Chicago, IL), poster;

2013

A phase 2 trial of azacitidine and gemtuzumab ozogamicin therapy in older patients with acute myeloid leukemia

S Nand;M Othus;JE Godwin;CL Willman;TH Norwood;DS Howard;SE Coutre;HP Erba;FR Appelbaum Blood 122(20):3432-3439;

PMid: PMID24092933 | PMC number: PMC3829116

Alteration of cytogenetic risk stratification in new diagnosis of leukemia by FISH testing - the SWOG experience

M Fang;S McDonough;M Othus;L Zhuo;D Roulston;H Erba;F Appelbaum Blood 122:1383; American Society of Hematology annual meeting (Dec 7-10, 2013, New Orleans, LA), poster;

2012

A Phase II Trial of Azacitidine (NSC-102816) and Gemtuzumab Ozogamicin (NSC-720568) as Induction and Post-Remission Therapy in Patients of Age 60 and Older with Previously Untreated Non-M3 Acute Myeloid Leukemia (SWOG S0703): Report on the Good Risk Patients

S Nand;H Gundacker;JE Godwin;C Willman;T Norwood;H Erba;D Howard;S Coutre;M Othus;F Appelbaum J Clin Oncol 30 (suppl; abstr 6502); American Society of Clinical Oncology 2012 Annual Meeting (June 1-5, 2012, Chicago, IL), oral presentation;