A Prospective Randomized Comparison of HDAC Vs AD in the Induction Chemothrapy for AML.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: High dose Cytarabine, Cytarabine, Hign dose Daunorubicin.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: 15 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Prospective Randomized Comparison of High-dose Cytarabine an High-dose Daunorubicin in the Induction Chemothrapy for Acute Myeloid Leukemia
Overview
This trial is a single-center, non-blind, two-arm randomized prospective controlled trial to compare the effectiveness of two induction chemotherapy regimens (high-dose cytarabine plus daunorubicin \[HDAC\] vs. cytarabine plus high-dose daunorubicin \[AD\]) in acute myeloid leukemia (AML). The primary hypothesis of the study is that AD is superior to HDAC in terms of event-free survival (EFS, time from registration to induction failure, relapse, or death).
Detailed description
* Induction chemotherapy
* Arm I \[HDAC\]: cytarabine 3.0 g/m2 q12hr 3-hour iv infusion on days 1, 3, 5 plus daunorubicin 45 mg/m2/day continuous iv infusion for 3 days (D1-3). * Arm II \[AD\]: cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7) plus daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3). * Interim bone marrow examination Interim bone marrow aspiration and biopsy will be done between 14 and 21 days after start of induction chemotherapy. If bone marrow has blasts \< 10%, no additional chemotherapy will be given until the recovery of blood counts (absolute neutrophil counts rise over 1,000/μL and platelet counts over 100,000/μL) or post-induction day 35, when bone marrow examination will be repeated to evaluate CR. After the marrow examination, re-induction course will be given. If interim bone marrow examination shows persistent leukemia (blasts ≥ 10%), re-induction course could be given. Patients who did not attain CR after the re-induction chemotherapy will be eliminated from the study. * Re-induction chemotherapy
* Cytarabine 200 mg/m2/day iv infusion for 5 days (D1-5) plus daunorubicin 45 mg/m2/day iv infusion for 2 days (D1-2) Post-remission consolidation chemotherapy * Adverse risk group: up to 3 courses of intermediate-dose cytarabine (1.0 g/m2/day iv for 5 days \[D1-5\]) plus etoposide (150 mg/m2/day iv for 3 days \[D1-3\]) * Favorable/intermediate risk group: up to 3 courses of high-dose cytarabine (3.0 g/m2/day q12 hr iv for 3 days \[D1, 3, 5\]) * Autologous or allogeneic hematopoietic cell transplantation (HCT) can be performed based on the risk of relapse. * The bone marrow examination will be done after the completion of consolidation chemotherapy or before HCT.
Interventions
- Drug High dose Cytarabine
High dose Cytarabine 3.0 g/m2 q12hr 3-hour iv infusion on days 1, 3, 5 plus daunorubicin 45 mg/m2/day continuous iv infusion for 3 days (D1-3). - Drug Cytarabine
cytarabine 200 mg/m2/day continuous iv infusion for 7 days (D1-7) - Drug Hign dose Daunorubicin
Hign dose Daunorubicin 90 mg/m2/day continuous iv infusion for 3 days (D1-3).
Primary outcome measures
- Cumulative incidence of relapse [Time frame: 3 years]
Secondary outcome measures (2)
- Event-free survival [Time frame: 3years]
- Overall survival [Time frame: 3years]
Eligibility criteria
Inclusion criteria
- Previously-untreated AML (≥ 20% blasts in bone marrow and/or peripheral blood)
- Age of 15 years or older, 60 years or younger
- Adequate performance status (Karnofsky score of 50 or more)
- Adequate hepatic and renal function (AST, ALT, and bilirubin < 2.5 x upper normal limit and creatinine < 2.0 mg/dL \& creatinine clearance ≥ 50 mL/min). Elevation of AST or ALT due to hepatic infiltration of leukemic cells will be permitted.
- Adequate cardiac function (left ventricular ejection fraction ≥45% on heart scan or echocardiogram)
- Signed informed consent
Exclusion criteria
- Patients with history of chemotherapy for leukemia or cytarabine and anthracycline treatment for any malignancy. Hydroxyurea for reduction of leukemic cell burden before induction chemotherapy will be permitted.
- Patients with acute promyelocytic leukemia
- Patients with blast crisis of chronic myeloid leukemia
- Patients with central nervous system (CNS) leukemia or granulocytic sarcoma without bone marrow involvement
- Presence of uncontrolled and/or severe medical condition (infection, bleeding, cardiovascular disease including myocardial infarction within previous 6 months.)
- Nursing women, pregnant women, women of childbearing potential who do not want adequate contraception
- Patients with a diagnosis of prior malignancy unless disease-free for at least 5 years following therapy with curative intent (except curatively treated nonmelanoma skin cancer, in situ carcinoma, or cervical intraepithelial neoplasia)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Asan Medical Center, University of Ulsan College of Medicine — Seoul
Identifiers
NCT: NCT03507842 · AMC_HDAC vs AD in AML