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

NCT01050036 | Completed

• 1 other identifier: AMC-H-54
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 11

Brief 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).

Conditions

Leukemia, Myeloid

Keywords

Leukemia, Myeloid; Primary complete remission; Favorable karyotype; Autologous hematopoietic cell transplantation; Hematopoietic cell transplantation

Outcome Measures

Primary Outcomes (1)

• cumulative incidence of relapse

  cumulative incidence of relapse

  3 years

Secondary Outcomes (5)

• Disease-free survival

  3 years

• engraftment rate

  100 days

• transplantation-related mortality

  100 days

• Event-free survival

  3 years

• Overall survival

  3 years

Study Arms (1)

HCT recipients

EXPERIMENTAL

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

Interventions

autologous hematopoietic cell transplantation PROCEDURE

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

Also known as: Busulfex, Etoposid, Grasin

HCT recipients

Eligibility Criteria

• Age: 15 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Asan Medical Center: lead

Study Sites (11)

Wonkwang University Hospital

Iksan, Chollabuk-do, 570749, South Korea

Location

Gyeongsang National University Hospital

Jinju, Gyeongsangnam-do, 660702, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, Kyeongki-do, 431796, South Korea

Location

Kosin University, Gospel Hospital

Busan, 602702, South Korea

Location

Busan Paik Hospital, Inje University College of Medicine

Busan, 614735, South Korea

Location

Daegu Fatima Hospital

Daegu, 701600, South Korea

Location

Yeongnam University Hospital

Daegu, 705717, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 705718, South Korea

Location

Gachon University Gil Hospital

Inchon, 405-760, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Ulsan University Hospital, University of Ulsan College of Medicine

Ulsan, 682714, South Korea

Location

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MeSH Terms

Conditions

Leukemia, Myeloid

Interventions

Busulfan

Condition Hierarchy (Ancestors)

Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Butylene Glycols; Glycols; Alcohols; Organic Chemicals; Mesylates; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Je-Hwan Lee, MD, PhD

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 14, 2010
• First Posted: January 15, 2010
• Study Start: January 11, 2010
• Primary Completion: October 30, 2018
• Study Completion: October 30, 2018
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (11)