Acute Myeloid Leukemia Clinical Trial
— CBF(+)AMLOfficial title:
Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).
Status | Recruiting |
Enrollment | 43 |
Est. completion date | December 2015 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Patients with CBF positive AML in CR1. CBF AML includes t(8;21)(q22;q22) [AML1(RUNX1)/ETO(CBFa2T1)], inv(16)(q13q22) (CBFß/MYH11),t(16;16)(p13;q22) (CBFß/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) |
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Asan Medical Center | Seoul | Asanbyeongwon-gil, songpa-gu |
Lead Sponsor | Collaborator |
---|---|
Cooperative Study Group A for Hematology |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CIR, DFS | Relapse incidence (cumulative incidence of relapse, CIR) Disease-free survival (DFS) |
6 years | Yes |
Secondary | TRM, EFS, OS | Engraftment rate / time to engraftment Transplantation-related mortality (TRM) Event-free survival (EFS) Overall survival (OS) |
6 years | Yes |
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