Clinical trial · Interventional
Autologous Hematopoietic Cell Transplantation for Core-binding Factor (CBF) Acute Myeloid Leukemia (AML) in the First Complete Remission (CR1)
Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
NCT01146977CI-TRIAL-00003587CBF(+)AMLunknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Autologous HCT | Other | — | UNRESOLVED |
| HDAC chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Autologous HCT
- description
- 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.
- interventionNames
- Other: Autologous HCT
- type
- ACTIVE_COMPARATOR
- label
- HDAC chemotherapy
- description
- If he/she decides not to participate, he/she will be treated with HDAC consolidation chemotherapy, which is the current standard treatment.
- interventionNames
- Other: HDAC chemotherapy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 15 Years
- Maximum age
- 65 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.