Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice (PURPLE-D)

March 4, 2016 updated by: Hawk Kim, Ulsan University Hospital

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)

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

136

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Ulsan, Korea, Republic of, 682714
        • Ulsan University Hospital
        • Contact:
        • Principal Investigator:
          • Hawk Kim, M.D., Ph.D.
        • Sub-Investigator:
          • Jae-Cheol Cho, M.D., Ph.D.
        • Sub-Investigator:
          • Yunsuk Choi, M.D., Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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/RARα 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of complete remission
Time Frame: after 4 cycles of decitabine treatment (about 4 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
The rate of composite CR
Time Frame: after 4 cycles of decitabine treatment (about 4 months)
CR+CRp+ CR with incomplete blood count recovery (CRi)
after 4 cycles of decitabine treatment (about 4 months)
Clinical benefit rate
Time Frame: after 4 cycles of decitabine treatment (about 4 months)
cCR(CR+CRp+CRi)+ partial remission (PR)+ stable disease (SD)
after 4 cycles of decitabine treatment (about 4 months)
Change of quality of life scale using EQ-5D-3L
Time Frame: after 4 cycles of decitabine treatment (about 4 months)
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)
Change of quality of life scale using EORTC QLQ-C30
Time Frame: after 4 cycles of decitabine treatment (about 4 months)
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)
Number of participants with treatment-related adverse events as assessed by CTCAE v4.03
Time Frame: until 4 cycles of decitabine treatment (about 4 months)
CTCAE version 4.03
until 4 cycles of decitabine treatment (about 4 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ulsan University Hospital

Collaborators

The Korean Society of Hematology, AML/MDS Working Party

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Anticipated)

August 1, 2019

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

February 19, 2016

First Submitted That Met QC Criteria

February 28, 2016

First Posted (Estimate)

March 3, 2016

Study Record Updates

Last Update Posted (Estimate)

March 7, 2016

Last Update Submitted That Met QC Criteria

March 4, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AMLMDSWP-201601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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