Autologous Hematopoietic Cell Transplantation for Core-binding Factor Acute Myeloid Leukemia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Asan Medical Center
Sponsor:
Information provided by (Responsible Party):
Je-Hwan Lee, Asan Medical Center
ClinicalTrials.gov Identifier:
NCT01050036
First received: January 14, 2010
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Leukemia, Myeloid
Procedure: autologous hematopoietic cell transplantation
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase 2 Study of Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission

Resource links provided by NLM:


Further study details as provided by Asan Medical Center:

Primary Outcome Measures:
  • cumulative incidence of relapse [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • engraftment rate [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • transplantation-related mortality [ Time Frame: 100 days ] [ Designated as safety issue: Yes ]
  • Event-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 39
Study Start Date: January 2010
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HCT recipients
  1. Patient with CBF AML will be eligible in his/her 1st complete remission (CR1) status. Patients who have relapsed or have achieved 2nd complete remission should not be included in this study.
  2. 1st postremission therapy after CR1 will be performed with high-dose cytarabine (HDAC) chemotherapy, consisting of intravenous cytarabine 3 g/m2 infusion during 3 hours twice a day on days 1, 3, and 5.
  3. After achieving CR1, patient will be invited to this protocol and will be able to decide whether to join or not after listening to the information.
Procedure: autologous hematopoietic cell transplantation
  1. Autologous peripheral blood stem cell (PBSCs) harvesting

    • After the second cycle of high-dose ara-C(HDAC) consolidation chemotherapy
    • Mobilization: recombinant human G-CSF(Filgrastim) 5mcg/kg s.c. daily starting on 10 days after start of the second cycle of HDAC chemotherapy
    • Harvest procedure: peripheral blood mononuclear cells will be collected. Target CD34+ cell dose is over 5x10E6/kg.
  2. Conditioning regimen for autologous HCT

    • Busulfan 3.2 mg/kg/day i.v. daily on days -7 to -5 (for 3 days)
    • Etoposide 400mg/m2/day i.v. daily on days -3 to -2 (for 2 days)
  3. Autologous cell infusion and waiting for engraftment
Other Names:
  • Busulfex
  • Etoposid
  • Grasin

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   15 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01050036

Contacts
Contact: Mijin Jeon, RN, CNS 82-2-3010-6689 mjjeon1982@gmail.com
Contact: Joo Youn Kim, RN 82-2-3010-6378 joobary2@naver.com

Locations
Korea, Republic of
Wonkwang University Hospital Recruiting
Iksan, Chollabuk-do, Korea, Republic of, 570749
Contact: Yeonghui Park, RN    82-63-859-2640    bej02@naver.com   
Principal Investigator: Hyeok Shim, M.D. & PhD.         
Gyeongsang National University Hospital Recruiting
Jinju, Gyeongsangnam-do, Korea, Republic of, 660702
Contact: Hyeok Choi, RN    82-55-750-9454    hyeau79@yahoo.co.kr   
Principal Investigator: Gyeong Won Lee, M.D. & PhD.         
Hallym University Sacred Heart Hospital Recruiting
Anyang, Kyeongki-do, Korea, Republic of, 431796
Contact: Hyo Jung Kim, M.D. & PhD.    82-31-380-3704    hemonc@hallym.or.kr   
Principal Investigator: Dae Young Zang, M.D. & PhD.         
Sub-Investigator: Hyo Jung Kim, M.D. & PhD.         
Kosin University, Gospel Hospital Recruiting
Busan, Korea, Republic of, 602702
Contact: Aeran Lee, RN    82-51-990-5820    chewon88@paran.com   
Principal Investigator: Yang Soo Kim, M.D. & PhD.         
Sub-Investigator: Seong-Hoon Shin, M.D. & PhD.         
Sub-Investigator: Ho-Sup Lee, M.D. & PhD.         
Busan Paik Hospital, Inje University College of Medicine Recruiting
Busan, Korea, Republic of, 614735
Contact: Hyejung Eum, RN    82-51-890-6987    cake78@nate.com   
Principal Investigator: Young-Don Joo, M.D. & PhD.         
Sub-Investigator: Won-Sik Lee, M.D. & PhD.         
Daegu Fatima Hospital Recruiting
Daegu, Korea, Republic of, 701600
Contact: Jung-eun Lee, RN    82-53-940-7687    chachaje@fatima.or.kr   
Principal Investigator: Jung-lim Lee, M.D. & PhD.         
Sub-Investigator: Sun-ah Lee, M.D. & PhD.         
Daegu Catholic University Medical Center Recruiting
Daegu, Korea, Republic of, 705718
Contact: Hun Mo Ryoo, M.D. & PhD    82-53-650-4034    rhmrhm@cu.ac.kr   
Contact: Sung Hwa Bae, M.D. & PhD    82-53-650-4388    sunghwa@cu.ac.kr   
Principal Investigator: Hun Mo Ryoo, M.D. & PhD         
Sub-Investigator: Sung Hwa Bae, M.D. & PhD         
Yeongnam University Hospital Recruiting
Daegu, Korea, Republic of, 705717
Contact: Young Mi Chun, RN    82-53-620-3069    jerry1032@hanmail.net   
Principal Investigator: Myung Soo Hyun, M.D. & PhD.         
Sub-Investigator: Min Kyoung Kim, M.D. & PhD.         
Gachon University Gil Hospital Recruiting
Inchon, Korea, Republic of, 405-760
Contact: Jin Hee Park, M.D. & PhD.         
Principal Investigator: Jin Hee Park, M.D. & PhD.         
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 138-736
Contact: Joo Youn Kim, RN    82-2-3010-6378    joobary2@naver.com   
Contact: Mijin Jeon, RN    82-2-3010-6689    mjjeon1982@gmail.com   
Sub-Investigator: Kyoo-Hyung Lee, M.D. & PhD         
Sub-Investigator: Je-Hwan Lee, M.D. & PhD         
Sub-Investigator: Jung-Hee Lee, M.D. & PhD.         
Principal Investigator: Dae-Young Kim, M.D.         
Ulsan University Hospital, University of Ulsan College of Medicine Recruiting
Ulsan, Korea, Republic of, 682714
Contact: Mi-young Kim, RN    82-52-250-8537    miyoung3798@yahoo.co.kr   
Contact: Eun-hee Lee, RN, CNS    82-52-250-8516    gival2@uuh.ulsan.kr   
Principal Investigator: Jae-Hoo Park, M.D. & PhD.         
Sub-Investigator: Young Joo Min, M.D. & PhD.         
Sub-Investigator: Hawk Kim, M.D. & PhD.         
Sponsors and Collaborators
Asan Medical Center
Investigators
Principal Investigator: Je-Hwan Lee, MD, PhD Asan Medical Center
  More Information

Publications:

Responsible Party: Je-Hwan Lee, Professor, Asan Medical Center
ClinicalTrials.gov Identifier: NCT01050036     History of Changes
Other Study ID Numbers: AMC-H-54
Study First Received: January 14, 2010
Last Updated: January 2, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by Asan Medical Center:
Leukemia, Myeloid
Primary complete remission
Favorable karyotype
Autologous hematopoietic cell transplantation
Hematopoietic cell transplantation

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on August 18, 2014