Phase 2
N=175
Standard Idarubicin and Cytarabine for the Treatment of Acute Myeloid Leukemia (AML)
Leukemia · Acute Myeloid Leukemia · AML
Bottom Line
View on ClinicalTrials.gov: NCT00422591 ↗Enrolled (actual)
175
Serious AEs
45.6%
Results posted
Jun 2018
Primary outcome: Primary: Complete Response (CR) Rate — 98; 4; 9; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cytarabine (Drug); Idarubicin (Drug)
- Age
- Pediatric, Adult, Older Adult · 15+ yrs
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jan 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Complete Response (CR) Rate |
98; 4; 9; 7; 51 | — |
| SECONDARY Event-Free Survival (EFS) |
4.7 | — |
| SECONDARY Overall Survival (OS) |
11.3 | — |
Summary
The goal of this clinical research study is to find out if standard chemotherapy given with idarubicin and Cytarabine (ara-C) can help to control AML.
Objectives:
To determine the complete response (CR) rate, event-free survival (EFS) and overall survival (OS) of patients with newly diagnosed acute myeloid leukemia (AML) receiving standard combination chemotherapy with Idarubicin and cytarabine.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of 1) AML (WHO classification definition of >/= 20% blasts). Patients with M6 AML with less than 20% blasts are eligible.
- Patients aged 15 to 75 years are eligible. Patients must be chemo-naïve, i.e. not have received any prior chemotherapy (except hydrea) for AML. They could have received transfusions, hematopoietic growth factors or vitamins. Temporary measures such as pheresis or hydrea (0.5 to 5g daily or more for up to 3 days) are allowed .
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0, 1, 2, or 3 at screening.
- Serum biochemical values with the following limits: - creatinine </= 2.0 mg/dl - total bilirubin </= 2.0 mg/dL, unless increase is due to hemolysis - transaminases (SG PT) </= 3x upper limit of normal (ULN)
- Ability to understand and provide signed informed consent.
Exclusion Criteria
- Subjects with Acute Promyelocytic Leukemia (APL).
- Presence of active systemic infection.
- Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results.
- Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of the study.
Data sourced from ClinicalTrials.gov (NCT00422591). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.