Safety and Efficacy Study of Idarubicin Dose Intensification to Treat Acute Myeloid Leukemia

NCT01518556 | Completed Phase 1 DMC

• 1 other identifier: AML-2011-01
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether idarubicin dose intensification is safe and effective as a remission induction therapy for acute myeloid leukemia.

Conditions

Leukemia, Myeloid, Acute

Keywords

Idarubicin; Remission Induction; Maximum Tolerated Dose; Survival

Outcome Measures

Primary Outcomes (2)

• Maximum tolerated dose of idarubicin in the phase I study.

  The study design is adopted from traditional 3+3 design for phase I cancer clinical trials. The first three patients are treated at a starting dose (level 1). If none of the three patients experiences a DLT(dose-limiting toxicity), another group of three patients will be treated at the next higher dose level. However, if one of the first three patients experiences a DLT, three more patients will be treated at the same dose level. The dose increment continues until at least two patients among a cohort of three to six patients experience DLTs.The maximum tolerated dose is defined as the dose level just below this toxic dose level.

  Within 2 months after induction therapy in the phase I study.

• Complete remission rate in the phase II study.

  A complete remission designation requires that the patient achieve the morphologic leukemia-free state and have an absolute neutrophil count of more than 1000 per microliter and platelets of more than 100000 per microliter. Hemoglobin concentration or hematocrit has no bearing on remission status, although the patient must be independent of transfusions.

  Within 2 months after induction therapy therappy in the phase II study.

Secondary Outcomes (2)

• Dose-limiting toxicity in the phase I study.

  Within 2 months after induction therapy in the phase I study.

• Event-free survival and overall survival in the phase II study.

  Within 5 years after induction therapy in the phase II study.

Study Arms (1)

Idarubicin

EXPERIMENTAL

Idarubicin dose intensification for remission induction in acute myeloid leukemia

Drug: Idarubicin

Interventions

Idarubicin DRUG

In the phase I study, idarubicin dose is increased step by step as follows: 12 mg/m2/day for 3 days IV in the 1st step; 15 mg/m2/day for 3 days IV in the 2nd step; 18 mg/m2/day for 3 days IV in the 3rd step. In the phase II study, idarubicin dose is the maximum tolerated dose that is determined from the phase I study or 18 mg/m2/day for 3 days .

Also known as: IDARU INJ

Idarubicin

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient has been fully informed, has complete understanding fo this study, and has given voluntary written informed consent to comply with the protocol requirements.
• previously untreated de novo or secondary acute myeloid leukemia, including biphenotypic leukemia
• age between 20 and 65 years
• adequate organ functions, unless these abnormalities are attributable to leukemia
• left ventricular ejection fraction \> 45%
• serum creatinine \< 1.5 x upper limit of normal
• total bilirubin \< 1.5 x upper limit of normal
• alanine transferase and aspartate transferase \< 2.5 x upper limit of normal if liver function abnormality is attributable to underlying leukemia, ALT and AST \< 5 x upper limit of normal
• Eastern Cooperative Oncology Group performance status score of 0 to 2

You may not qualify if:

• hypersensitivity to the study drug
• any other malignancies within 3 years, except for cured non-melanoma skin cancer and curatively treated in situ carcinoma of the cervix
• New York Heart Association class III or IV heart failure, severe uncontrolled cardiac disease or myocardial infarction within the previous 6 months prior to the date of consent
• incapable of giving voluntary written informed consent to comply with the protocol requirements, which results from drug or alcohol intoxication, or neurological or psychiatric disorders
• pregnant or breastfeeding
• recent chemotherapy within 4 weeks prior to this study treatment
• acute promyelocytic leukemia
• current or recent treatment with any other investigational medicinal product within 28 days prior to this study enrollment
• unsuitable for this study, in the investigator's opinion

Sponsors & Collaborators

• Konkuk University Medical Center: lead
• Chung-Ang University Hosptial, Chung-Ang University College of Medicine: collaborator
• Seoul National University Hospital: collaborator
• Ewha Womans University: collaborator
• Samsung Medical Center: collaborator
• Chonbuk National University Hospital: collaborator
• Pusan National University Hospital: collaborator
• Hanyang University Seoul Hospital: collaborator
• Soon Chun Hyang University: collaborator

Study Sites (1)

Division of Hematology-Oncology, Konkuk University Medical Center

Seoul, 143-729, South Korea

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Idarubicin

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Mark H Lee, M.D., Ph.D.

  Konkuk University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 21, 2012
• First Posted: January 26, 2012
• Study Start: July 1, 2011
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

KR (1)