Acute Myeloid Leukemia, Elderly, Intensive Chemotherapy Unfit
Conditions
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)
Interventions
DRUGDecitabine
Sponsors
The Korean Society of Hematology, AML/MDS Working Party
Ulsan University Hospital
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The rate of complete remission | 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
| Measure | Time frame | Description |
|---|---|---|
| The rate of composite CR | after 4 cycles of decitabine treatment (about 4 months) | CR+CRp+ CR with incomplete blood count recovery (CRi) |
| Clinical benefit rate | 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 | 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 | 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 | until 4 cycles of decitabine treatment (about 4 months) | CTCAE version 4.03 |
Countries
South Korea
Outcome results
None listed