Autologous Hematopoietic Cell Transplantation for Core-binding Factor (CBF) Acute Myeloid Leukemia (AML) in the First Complete Remission (CR1) (CBF(+)AML)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2010 by Cooperative Study Group A for Hematology
Sponsor:
Information provided by:
Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier:
NCT01146977
First received: May 19, 2010
Last updated: June 17, 2010
Last verified: June 2010
  Purpose

Evaluation of efficacy of autologous hematopoietic cell transplantation (HCT) with core-binding factor (CBF) positive acute myeloid leukemia (AML) in the first CR (CR1).


Condition Intervention Phase
Acute Myeloid Leukemia
Other: HDAC chemotherapy
Other: Autologous HCT
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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 Cooperative Study Group A for Hematology:

Primary Outcome Measures:
  • CIR, DFS [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
    • Relapse incidence (cumulative incidence of relapse, CIR)
    • Disease-free survival (DFS)


Secondary Outcome Measures:
  • TRM, EFS, OS [ Time Frame: 6 years ] [ Designated as safety issue: Yes ]
    • Engraftment rate / time to engraftment
    • Transplantation-related mortality (TRM)
    • Event-free survival (EFS)
    • Overall survival (OS)


Estimated Enrollment: 43
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous HCT

5.1.3. 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.

5.1.3.1. If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue.

Other: Autologous HCT

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.

If he/she decides to participate, request of health insurance support on the autologous HCT will be submitted and further processes related to autologous HCT will continue.

Active Comparator: HDAC chemotherapy
If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment.
Other: HDAC chemotherapy
If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment.
Other Name: Cytarabine 3g/m2

  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: NCT01146977

Contacts
Contact: Dae-Young Kim, professor 82-2-3010-5930 dani@amc.seoul.kr

Locations
Korea, Republic of
Asan Medical Center Recruiting
Seoul, Asanbyeongwon-gil, songpa-gu, Korea, Republic of, 138-736
Contact: Yae Eun Jang, nurse    82-2-3010-6378    redpin75@paran.com   
Sponsors and Collaborators
Cooperative Study Group A for Hematology
Investigators
Principal Investigator: Dae-Young Kim, professor Asan Medical Center
  More Information

Additional Information:
No publications provided

Responsible Party: COSAH, Cooperative Study Group A for Hematology
ClinicalTrials.gov Identifier: NCT01146977     History of Changes
Other Study ID Numbers: C-020
Study First Received: May 19, 2010
Last Updated: June 17, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by Cooperative Study Group A for Hematology:
CBF(+)

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

ClinicalTrials.gov processed this record on July 29, 2014