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Acute Myeloid LeukemiaPURPLE-DNCT02698124

Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice

An observational study of Acute Myeloid Leukemia and Elderly, run by Ulsan University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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) Read more about this study

Who is it for?
Ages 65 years and older
What is being tested?
Decitabine
Type of treatment
Injection or infusion
How many people
136 participants
Where
1 siteSouth Korea
Study dates
Mar 2016to Dec 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

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

Who may be able to join

  • Newly diagnosed and therapy-naïve AML (bone marrow or peripheral blood blast counts ≥20%)
  • 65 years of age or older
  • Taking informed consent with signature and date
  • Not eligible for iIC based on either:
  • ≥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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • Ulsan University Hospital

    Ulsan, 682714

    Hawk Kim, M.D., Ph.D., +82-52-250-8892, kimhawkmd@gmail.com

    Hawk Kim, M.D., Ph.D.

Other trials in South Korea

About this study

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

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)

Being tested
Decitabine
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02698124
Study groupRoleWhat they receive
DecitabineDecitabine 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.
Receives: Drug: Decitabine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: after 4 cycles of decitabine treatment (about 4 months)

Secondary outcomes (5)

  1. The rate of composite CR

    CR+CRp+ CR with incomplete blood count recovery (CRi)

    Measured: after 4 cycles of decitabine treatment (about 4 months)

  2. Clinical benefit rate

    cCR(CR+CRp+CRi)+ partial remission (PR)+ stable disease (SD)

    Measured: after 4 cycles of decitabine treatment (about 4 months)

  3. 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.

    Measured: after 4 cycles of decitabine treatment (about 4 months)

  4. 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.

    Measured: after 4 cycles of decitabine treatment (about 4 months)

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

    CTCAE version 4.03

    Measured: until 4 cycles of decitabine treatment (about 4 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2016 (estimated)
  2. Study startMar 2016
  3. Primary completionAug 2019 (estimated)
  4. Study completionDec 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Ecologic or community
Time perspective
Prospective
Enrolment
136 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02698124
Sponsor's protocol ID
AMLMDSWP-201601
Acronym
PURPLE-D
Status last verified
Mar 2016
First submitted
19 Feb 2016
Last updated
7 Mar 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 22689805

  • 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.

    PubMed 20368434

  • 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.

    PubMed 23178755

  • 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.

    PubMed 22902148

  • 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.

    PubMed 24503739

  • 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

  • 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.

    PubMed 14673054

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myeloid Leukemia and Elderly, run by Ulsan University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The rate of complete remission (time frame: after 4 cycles of decitabine treatment (about 4 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02698124, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2016.

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