Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice

Acute Myeloid Leukemia Clinical Trial

— PURPLE-D  

Official title:

Prospective Observation of the indUction Regimen for Acute Non-Promyelocytic Myeloid Leukemia in Elderly; Decitabine for Chemotherapy Unfit Korean Acute Myeloid Leukemia (AML) Patients in Real Practice

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02698124
• Other study ID #: AMLMDSWP-201601
• Status: Not yet recruiting
• Phase: N/A
• First received: February 19, 2016
• Last updated: March 4, 2016
• Start date: March 2016
• Est. completion date: December 2022

Study information

• Verified date: March 2016
• Source: Ulsan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 136
• Est. completion date: December 2022
• Est. primary completion date: August 2019
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

1. Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts =20%)

2. 65 years of age or older

3. Taking informed consent with signature and date

4. 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

Exclusion Criteria:

1. Candidate for iIC at the time of enrollment

2. Promyelocytic leukemia, or AML with t(15;17) or PML/RARa rearrangement

3. AML with t(9;22) or BCR/ABL rearrangement

4. Leukemia central nervous system involvement

5. Extramedullary myeloid sarcoma without bone marrow involvement

6. Prior treatment with decitabine or azacitidine of any cause

7. Any leukemia-specific therapy, except for hydroxyurea for reducing leukemic cells prior decitabine

8. 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

9. Premenopausal woman

10. Severe active infection

11. Uncontrolled bleeding Hypersensitivity to decitabine

Study Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Elderly
• Intensive Chemotherapy Unfit
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute

Intervention

Drug:
• Decitabine

Locations

Country	Name	City	State
Korea, Republic of	Ulsan University Hospital	Ulsan

Sponsors (2)

Lead Sponsor	Collaborator
Ulsan University Hospital	The Korean Society of Hematology, AML/MDS Working Party

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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 resp — View Citation

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.

Cheson BD, Bennett JM, Kopecky KJ, Büchner T, Willman CL, Estey EH, Schiffer CA, Doehner H, Tallman MS, Lister TA, Lo-Coco F, Willemze R, Biondi A, Hiddemann W, Larson RA, Löwenberg B, Sanz MA, Head DR, Ohno R, Bloomfield CD; International Working Group f — View Citation

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, Lysák D, Minden M, Arthur C. Multicenter, randomized, open-label, phase III trial of decitab — View Citation

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.pon — View Citation

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, Mrózek K, Bloomfield CD, Blum W, Garzon R, Schwind S, Marcu — View Citation

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Secondary	The rate of composite CR	CR+CRp+ CR with incomplete blood count recovery (CRi)	after 4 cycles of decitabine treatment (about 4 months)	No
Secondary	Clinical benefit rate	cCR(CR+CRp+CRi)+ partial remission (PR)+ stable disease (SD)	after 4 cycles of decitabine treatment (about 4 months)	No
Secondary	Change of quality of life scale using EQ-5D-3L	Quality of life measurement by EQ-5D will be compared between pre- and post-decitabine therapy.	after 4 cycles of decitabine treatment (about 4 months)	No
Secondary	Change of quality of life scale using EORTC QLQ-C30	Quality of life measurement by EORTC QLQ-C30 will be compared between pre- and post-decitabine therapy.	after 4 cycles of decitabine treatment (about 4 months)	No
Secondary	Number of participants with treatment-related adverse events as assessed by CTCAE v4.03	CTCAE version 4.03	until 4 cycles of decitabine treatment (about 4 months)	Yes