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

U

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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