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

NCT01146977 | Unknown Phase 2

• 1 other identifier: C-020
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Myeloid Leukemia

Keywords

CBF(+)

Outcome Measures

Primary Outcomes (1)

• CIR, DFS

  * Relapse incidence (cumulative incidence of relapse, CIR) * Disease-free survival (DFS)

  6 years

Secondary Outcomes (1)

• TRM, EFS, OS

  6 years

Study Arms (2)

Autologous HCT

EXPERIMENTAL

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

HDAC chemotherapy

ACTIVE COMPARATOR

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

Interventions

HDAC chemotherapy OTHER

If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment.

Also known as: Cytarabine 3g/m2

HDAC chemotherapy

Autologous HCT OTHER

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.

Autologous HCT

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

• Cooperative Study Group A for Hematology: lead

Study Sites (1)

Asan Medical Center

Seoul, Asanbyeongwon-gil, Songpa-gu, 138-736, South Korea

RECRUITING

Related Links

• Autologous hematopoietic cell transplantation for core-binding factor positive acute myeloid leukemia in the first complete remission

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Cytarabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Dae-Young Kim, professor

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dae-Young Kim, professor

CONTACT

82-2-3010-5930; dani@amc.seoul.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: May 19, 2010
• First Posted: June 22, 2010
• Study Start: January 1, 2010
• Primary Completion: January 1, 2010
• Study Completion: December 1, 2015
• Last Updated: June 22, 2010

Record last verified: 2010-06

Locations

KR (1)