SWOG clinical trial number
S1117

A Randomized Phase II Study of Azacitidine in Combination with Lenalidomide (NSC-703813) vs. Azacitidine Alone vs. Azacitidine in Combination with Vorinostat (NSC-701852) for Higher-Risk Myelodysplastic Syndromes (MDS) and Chronic Myelomonocytic Leukemia (CMML)

Closed
Phase
Accrual
100%
Published
Abbreviated Title
Rando PII Aza vs. Aza/Len vs. Aza/Vorin for High Risk MDS and CMML
Activated
03/01/2012
Closed
11/14/2014
Participants
NCORP, Members, Medical Oncologists, CTSU, Affiliates

Research committees

Leukemia

Treatment

Azacitidine CC-5013 (Lenalidomide) Suberoylanilide Hydroxamic Acid (SAHA; Vorinostat)

Eligibility Criteria Expand/Collapse

-Pts must have morphologically confirmed MDS or CMML by FAB, WHO or IPSS score; AML pts are not eligible. (Procedures for establishing baseline disease must be done within 30 days prior to reg.)
-Pts must not have received lenalidomide, azacitidine, vorinostat or decitabine as treatment previously. Hem growth factors must be stopped >/= 14 days prior to reg. Pts may have received low dose cytarabine for MDS treatment previously, but must have stopped its use for >/= 28 days prior to reg.
-Patients must not have received radiation therapy, chemotherapy, or cytotoxic therapy to treat conditions other than MDS within 12 months prior to registration.
-Pts must not have undergone prior allo stem cell or bone marrow transplantation at any time.
-Pts must not have received > physiologic doses of a corticosteroid agent within 28 days prior to reg.
-Pts must be >/= 18 years of age.
-Pts must have Zubrod Performance Status of 0-2.
-Pretreatment cytogenetics must be performed on all patients. Collection of pretreatment specimens must be completed within 30 days prior to reg.
-Pts must be offered participation in specimen banking
-Pts must not have any pre-existing neurotoxicity/neuropathy of �� Grade 2 by CTCAE 4.0, or prior �� Grade 3 allergic reaction/hypersensitivity or rash to thalidomide, that has not resolved to < Grade 2.
-Pts must not have any serious medical condition, laboratory abnormality, or psychiatric illness that, in the view of the treating physician, would place the participant at an unacceptable risk if he or she were to participate in the study or would prevent that person from giving informed consent.
-Pts must not have history of thromboembolic event or other condition requiring current use of anticoagulation with coumadin (warfarin) or low molecular-weight heparin.
-Pts must not have known or suspected hypersensitivity to mannitol.
-Pts must not have used or be using HDAC inhibitor agents for anticancer treatment.
-Pts may not have received agents such as valproic acid for epilepsy within 30 days prior to reg.
-Patients must receive a 12-lead EKG, chest x-ray, serum creatinine, complete metabolic panel including SGOT or SGPT, electrolytes, and bilirubin testing within 28 days prior to reg.
-Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test (sensitivity >/= 25 mIU/mL) within 10 �C 14 days prior to reg and must agree to have a second pregnancy test within 24 hours prior to starting Cycle 1 if randomized to receive lenalidomide. Further, patients commit to the outlined contraception and education/counseling for lenalidomide.
-No prior malignancy is allowed except for adequately treated basal (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for three years.
-All pts must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.

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

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

2017

A randomized phase II study of azacitidine alone or in combination with lenalidomide or with vorinostat vs. azacitidine monotherapy in higher-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML): North American Intergroup Study SWOG S1117

M Sekeres;M Othus;AF List;O Odenike;RM Stone;S Gore;M Litzow;R Buckstein;M Fang;D Roulston;C Bloomfield;A Moseley;Y Zhang;MR Velasco;R Gaur;E Attallah;E Attar;MJ Rauh;F Appelbaum;H Erba Journal of Clinical Oncology Aug 20;35(24):2745-2753; 2017 May 9 [Epub ahead of print]

PMid: PMID28486043; PMC5562170

2016

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

Additional analyses of a randomized phase II study of azacitidine combined with lenalidomide or with vorinostat vs. azacitidine monotherapy in higher-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML): North American Intergroup Study SWOG S1117

M Sekeres;M Othus;A List;O Odenike;R Stone;S Gore;M Litzlow;R Buckstein;M Fang;D Roulston;C Bloomfield;Y Zhang;M Velasco;R Gaur;E Atallah;A Attar;F Appelbaum;H Erba Blood 126(23):908; American Society of Hematology Annual Meeting (Dec 5-8, 2015, Orlando, FL), oral;

2014

NCI pilot intervention program to assist accrual for challenging late phase clinical trials

A Denicoff;H Massett;E Souhan;JJ Welch;N Seibel;RF Little;BS Mann;K DiPiazza;M Rossmann;S Hartson Stine;R Lambersky;F Desanto;F Fonzi;D Schrag;RA Abrams;DJ Adelstein;PD Brown;M Mooney;J Abrams Journal of Clinical Oncology 32:5s (suppl; abstr 6617); ASCO Annual Meeting (May 30-June 3, 2014, Chicago, IL), general poster session;

A randomized phase II study of azacitidine combined with lenalidomide or with vorinostat vs. azacitidine monotherapy in higher-risk myelodysplastic syndromes (MDS) and chronic myelomonocytic leukemia (CMML): North American Intergroup study SWOG S1117

M Sekeres;M Othus;AF List;O Odenike;RM Stone;S Gore;M Litzow;R Buckstein;M Velasco;R Gaur;E Attallah;EC Attar;FR Appelbaum;HP Erba Blood 124(21):LBA-5; American Society for Hematology (December 6-9, 2014, San Francisco, CA), LBA, oral;

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