Autologous Hematopoietic Cell Transplantation for Core-binding Factor Acute Myeloid Leukemia
South Korea20 participantsStarted 2010-01-11
Plain-language summary
Primary study objective is the evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1) in terms of relapse incidence (cumulative incidence of relapse, CIR) and disease-free survival (DFS).
Secondary study objectives are the engraftment rate / time to engraftment, transplantation-related mortality (TRM) rate, event-free survival (EFS) rate, and Overall survival (OS).
Who can participate
Age range15 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patients with CBF positive AML in CR1. CBF AML includes t(8;21)(q22;q22) \[AML1(RUNX1)/ETO(CBFα2T1)\], inv(16)(q13q22) (CBFβ/MYH11), t(16;16)(p13;q22) (CBFβ/MYH11) Using RT-PCR, FISH, or standard karyotype analysis technique.
* Patients who plan to receive the second cycle of HDAC consolidation chemotherapy.
* 15 years old or older and 65 years or younger
* Adequate performance status (Karnofsky score of 70 or more).
* Adequate hepatic and renal function (AST, ALT, and bilirubin \< 3.0 x upper normal limit, and creatinine \< 2.0 mg/dL).
* Adequate cardiac function (left ventricular ejection fraction over 40% on heart scan or echocardiography)
* Signed and dated informed consent must be obtained from patient.
Exclusion Criteria:
* Presence of significant active infection
* Presence of uncontrolled bleeding
* Any coexisting major illness or organ failure
* Patients with psychiatric disorder or mental deficiency severe as to make compliance with the treatment unlike, and making informed consent impossible
* 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)