Decitabine for Chemotherapy Unfit Korean AML Patients in Real Practice

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

136 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2022-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Decitabine Combined With Unrelated Cord Blood Transplantation for Elderly Patients With AML

NCT03913312

Acute Myeloid Leukemia

UNKNOWN PHASE1/PHASE2

Decitabine in Combination With Low-dose Cytarabine in Elderly Patients With Acute Myeloid Leukemia

NCT02985372

Acute Myeloid Leukemia, Adult

UNKNOWN PHASE3

Decitabine as Maintenance Therapy After Standard Therapy in Treating Patients With Previously Untreated Acute Myeloid Leukemia

NCT00416598

Acute Myeloid Leukemia Acute Myeloid Leukemia With Myelodysplasia-Related Changes Adult Acute Myeloid Leukemia With Inv(16)(p13.1q22); CBFB-MYH11 +4 more

COMPLETED PHASE2

Dose Finding Study of Post-BMT Decitabine Maintenance Treatment in Higher-risk MDS and MDS/AML

NCT01277484

Myelodysplastic Syndrome Acute Myeloid Leukemia

UNKNOWN PHASE1

Study of Low-Dose Intravenous Decitabine in Patients Aged > 60 Years With Acute Myeloid Leukemia

NCT00866073

Acute Myeloid Leukemia

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Acute Myeloid Leukemia Elderly Intensive Chemotherapy Unfit

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Decitabine

Intervention Type DRUG

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Decitabine

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No