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

Ulsan University Hospital

Status: Unknown

Conditions: Intensive Chemotherapy Unfit; Elderly; Acute Myeloid Leukemia

Treatments: Drug: Decitabine

Study type: Observational

Funder types: Other

Identifiers

NCT02698124

AMLMDSWP-201601

Details and patient eligibility

About

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)

Enrollment: 136 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: No Healthy Volunteers

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

Trial design

136 participants in 1 patient group

Decitabine

Description:

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.

Treatment:

Drug: Decitabine