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

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ClinicalTrials.gov Identifier: NCT02698124
Recruitment Status : Not yet recruiting
First Posted : March 3, 2016
Last Update Posted : March 7, 2016
Sponsor:
Collaborator:
The Korean Society of Hematology, AML/MDS Working Party
Information provided by (Responsible Party):
Hawk Kim, Ulsan University Hospital

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)

Condition or disease Intervention/treatment
Acute Myeloid Leukemia Elderly Intensive Chemotherapy Unfit Drug: Decitabine

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Study Type : Observational
Estimated Enrollment : 136 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
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
Study Start Date : March 2016
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : December 2022


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. Clinical benefit rate [ Time Frame: after 4 cycles of decitabine treatment (about 4 months) ]
    cCR(CR+CRp+CRi)+ partial remission (PR)+ stable disease (SD)

  3. 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.

  4. 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.

  5. 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


Biospecimen Retention:   Samples With DNA
miRNA, TET, whole genome sequencing


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698124


Locations
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Korea, Republic of
Ulsan University Hospital
Ulsan, Korea, Republic of, 682714
Contact: Hawk Kim, M.D., Ph.D.    +82-52-250-8892    kimhawkmd@gmail.com   
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.         
Sponsors and Collaborators
Ulsan University Hospital
The Korean Society of Hematology, AML/MDS Working Party
Publications of Results:
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

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Responsible Party: Hawk Kim, Professor, Ulsan University Hospital
ClinicalTrials.gov Identifier: NCT02698124    
Other Study ID Numbers: AMLMDSWP-201601
First Posted: March 3, 2016    Key Record Dates
Last Update Posted: March 7, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms
Decitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Enzyme Inhibitors