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
|Condition or disease||Intervention/treatment|
|Acute Myeloid Leukemia Elderly Intensive Chemotherapy Unfit||Drug: Decitabine|
|Study Type :||Observational|
|Estimated Enrollment :||136 participants|
|Observational Model:||Ecologic or Community|
|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|
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.
- 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.
- 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)
- Clinical benefit rate [ Time Frame: after 4 cycles of decitabine treatment (about 4 months) ]cCR(CR+CRp+CRi)+ partial remission (PR)+ stable disease (SD)
- 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.
- 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.
- 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
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
|Korea, Republic of|
|Ulsan University Hospital|
|Ulsan, Korea, Republic of, 682714|
|Contact: Hawk Kim, M.D., Ph.D. +82-52-250-8892 firstname.lastname@example.org|
|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.|