Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice

NCT02698124 | Unknown

• 1 other identifier: AMLMDSWP-201601
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective multicenter, open-lab el, observational, single arm study of decitabine. Subjects will be elderly patients with newly diagnosed, treatment-naïve AML who are unfit to receive and not candidate for intensive induction chemotherapy (iIC)

Conditions

Acute Myeloid Leukemia; Elderly; Intensive Chemotherapy Unfit

Outcome Measures

Primary Outcomes (1)

• The rate of complete remission

  The rate of complete remission and complete remission with incomplete platelet recovery (CRp) will be measured by 4 cycles of decitabine treatment.

  after 4 cycles of decitabine treatment (about 4 months)

Secondary Outcomes (5)

• The rate of composite CR

  after 4 cycles of decitabine treatment (about 4 months)

• Clinical benefit rate

  after 4 cycles of decitabine treatment (about 4 months)

• Change of quality of life scale using EQ-5D-3L

  after 4 cycles of decitabine treatment (about 4 months)

• Change of quality of life scale using EORTC QLQ-C30

  after 4 cycles of decitabine treatment (about 4 months)

• Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

  until 4 cycles of decitabine treatment (about 4 months)

Study Arms (1)

Decitabine

Decitabine 20mg/m2 will be given IV daily on Days 1-5 in 28-day cycles. Treatment should be given for at least 4 cycles in the absence of unacceptable toxicity or disease progression requiring alternative therapy. Beyond 4 cycles, treatment should continue as long as the subject continues to benefit based on investigator's judgment of no definitive progression.

Drug: Decitabine

Interventions

Decitabine DRUG

Decitabine

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

elderly patients with previously untreated AML who are ufit to receive and not considered candidates for iIC at the time of enrollment

You may qualify if:

• Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts ≥20%)
• years of age or older
• Taking informed consent with signature and date
• Not eligible for iIC based on either:
• i) ≥75 years of age ii) comorbidity iii) secondary AML iv) poor performance (ECOG ≥2) v) Poor-risk by NCCN Guideline version 1.2015 vi) subject's choice (refusal for iIC) investigator's judgement incompatible with iIC

You may not qualify if:

• Candidate for iIC at the time of enrollment
• Promyelocytic leukemia, or AML with t(15;17) or PML/RARα rearrangement
• AML with t(9;22) or BCR/ABL rearrangement
• Leukemia central nervous system involvement
• Extramedullary myeloid sarcoma without bone marrow involvement
• Prior treatment with decitabine or azacitidine of any cause
• Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine
• Second malignancy currently requiring active therapy except breast or prostate cancer stable on or responding to endocrine therapy, or curatively resected non-melanoma skin cancer or intraepithelial cancer
• Premenopausal woman
• Severe active infection
• Uncontrolled bleeding Hypersensitivity to decitabine

Sponsors & Collaborators

• Ulsan University Hospital: lead
• The Korean Society of Hematology, AML/MDS Working Party: collaborator

Study Sites (1)

Ulsan University Hospital

Ulsan, 682714, South Korea

Location

Related Publications (7)

• Kantarjian HM, Thomas XG, Dmoszynska A, Wierzbowska A, Mazur G, Mayer J, Gau JP, Chou WC, Buckstein R, Cermak J, Kuo CY, Oriol A, Ravandi F, Faderl S, Delaunay J, Lysak D, Minden M, Arthur C. Multicenter, randomized, open-label, phase III trial of decitabine versus patient choice, with physician advice, of either supportive care or low-dose cytarabine for the treatment of older patients with newly diagnosed acute myeloid leukemia. J Clin Oncol. 2012 Jul 20;30(21):2670-7. doi: 10.1200/JCO.2011.38.9429. Epub 2012 Jun 11.

  PMID: 22689805 RESULT

• Blum W, Garzon R, Klisovic RB, Schwind S, Walker A, Geyer S, Liu S, Havelange V, Becker H, Schaaf L, Mickle J, Devine H, Kefauver C, Devine SM, Chan KK, Heerema NA, Bloomfield CD, Grever MR, Byrd JC, Villalona-Calero M, Croce CM, Marcucci G. Clinical response and miR-29b predictive significance in older AML patients treated with a 10-day schedule of decitabine. Proc Natl Acad Sci U S A. 2010 Apr 20;107(16):7473-8. doi: 10.1073/pnas.1002650107. Epub 2010 Apr 5.

  PMID: 20368434 RESULT

• Mims A, Walker AR, Huang X, Sun J, Wang H, Santhanam R, Dorrance AM, Walker C, Hoellerbauer P, Tarighat SS, Chan KK, Klisovic RB, Perrotti D, Caligiuri MA, Byrd JC, Chen CS, James Lee L, Jacob S, Mrozek K, Bloomfield CD, Blum W, Garzon R, Schwind S, Marcucci G. Increased anti-leukemic activity of decitabine via AR-42-induced upregulation of miR-29b: a novel epigenetic-targeting approach in acute myeloid leukemia. Leukemia. 2013 Apr;27(4):871-8. doi: 10.1038/leu.2012.342. Epub 2012 Nov 26.

  PMID: 23178755 RESULT

• Suzuki H, Maruyama R, Yamamoto E, Kai M. DNA methylation and microRNA dysregulation in cancer. Mol Oncol. 2012 Dec;6(6):567-78. doi: 10.1016/j.molonc.2012.07.007. Epub 2012 Aug 10.

  PMID: 22902148 RESULT

• Kim Y, Cheong JW, Kim YK, Eom JI, Jeung HK, Kim SJ, Hwang D, Kim JS, Kim HJ, Min YH. Serum microRNA-21 as a potential biomarker for response to hypomethylating agents in myelodysplastic syndromes. PLoS One. 2014 Feb 4;9(2):e86933. doi: 10.1371/journal.pone.0086933. eCollection 2014.

  PMID: 24503739 RESULT

• Castoro RJ, Dekmezian M, Saraf AJ, Watanabe Y, Chung W, Adhab SE, et al. MicroRNA 124 and Its Role in Response to Epigenetic Therapy in Patients with Acute Mylogenous Leukemia and Myelodysplastic Syndrome. American Society of Hematology 2008; Abstract No. 598

  RESULT

• Cheson BD, Bennett JM, Kopecky KJ, Buchner T, Willman CL, Estey EH, Schiffer CA, Doehner H, Tallman MS, Lister TA, Lo-Coco F, Willemze R, Biondi A, Hiddemann W, Larson RA, Lowenberg B, Sanz MA, Head DR, Ohno R, Bloomfield CD; International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. Revised recommendations of the International Working Group for Diagnosis, Standardization of Response Criteria, Treatment Outcomes, and Reporting Standards for Therapeutic Trials in Acute Myeloid Leukemia. J Clin Oncol. 2003 Dec 15;21(24):4642-9. doi: 10.1200/JCO.2003.04.036.

  PMID: 14673054 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

miRNA, TET, whole genome sequencing

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Decitabine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Azacitidine; Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 19, 2016
• First Posted: March 3, 2016
• Study Start: March 1, 2016
• Primary Completion: August 1, 2019
• Study Completion: December 1, 2022
• Last Updated: March 7, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)