Status:
UNKNOWN
Autologous Hematopoietic Cell Transplantation for Core-binding Factor (CBF) Acute Myeloid Leukemia (AML) in the First Complete Remission (CR1)
Lead Sponsor:
Cooperative Study Group A for Hematology
Conditions:
Acute Myeloid Leukemia
Eligibility:
All Genders
15-65 years
Phase:
PHASE2
Brief Summary
Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).
Detailed Description
5.2 AUTOLOGOUS PBSCS HARVESTING 5.2.1. PBSCs will be collected during recovery phase after the second cycle of HDAC consolidation chemotherapy. 5.2.2. For mobilization, recombinant human granulocyte...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2015
Estimated Enrollment :
43 Patients enrolled
Trial Details
Trial ID
NCT01146977
Start Date
January 1 2010
End Date
December 1 2015
Last Update
June 22 2010
Active Locations (1)
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1
Asan Medical Center
Seoul, Asanbyeongwon-gil, Songpa-gu, South Korea, 138-736