Clinical trial · Interventional
Autologous Hematopoietic Cell Transplantation for Core-binding Factor Acute Myeloid Leukemia
Phase 2 Study of Autologous Hematopoietic Cell Transplantation for Core-binding Factor Positive Acute Myeloid Leukemia in the First Complete Remission
NCT01050036CI-TRIAL-00087314completedN/AClinicalTrials.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)
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
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 |
|---|---|---|---|
| Leukemia, Myeloid | Myeloid Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| autologous hematopoietic cell transplantation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- HCT recipients
- description
- 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.
- interventionNames
- Procedure: autologous hematopoietic cell transplantation
Primary outcomes (1)
- measure
- cumulative incidence of relapse
- timeFrame
- 3 years
- description
- cumulative incidence of relapse
Secondary outcomes (5)
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 (33)
- BACKGROUNDByrd JC, Mrozek K, Dodge RK, Carroll AJ, Edwards CG, Arthur DC, Pettenati MJ, Patil SR, Rao KW, Watson MS, Koduru PR, Moore JO, Stone RM, Mayer RJ, Feldman EJ, Davey FR, Schiffer CA, Larson RA, Bloomfield CD; Cancer and Leukemia Group B (CALGB 8461). Pretreatment cytogenetic abnormalities are predictive of induction success, cumulative incidence of relapse, and overall survival in adult patients with de novo acute myeloid leukemia: results from Cancer and Leukemia Group B (CALGB 8461). Blood. 2002 Dec 15;100(13):4325-36. doi: 10.1182/blood-2002-03-0772. Epub 2002 Aug 1. PMID 12393746
- BACKGROUNDBurgess JK, Lopez JA, Berndt MC, Dawes I, Chesterman CN, Chong BH. Quinine-dependent antibodies bind a restricted set of epitopes on the glycoprotein Ib-IX complex: characterization of the epitopes. Blood. 1998 Oct 1;92(7):2366-73. PMID 9746776
- BACKGROUNDSlovak ML, Kopecky KJ, Wolman SR, Henslee-Downey JP, Appelbaum FR, Forman SJ, Blume KG. Cytogenetic correlation with disease status and treatment outcome in advanced stage leukemia post bone marrow transplantation: a Southwest Oncology Group study (SWOG-8612). Leuk Res. 1995 Jun;19(6):381-8. doi: 10.1016/0145-2126(94)00162-4. PMID 7596150
- BACKGROUNDPaschka P. Core binding factor acute myeloid leukemia. Semin Oncol. 2008 Aug;35(4):410-7. doi: 10.1053/j.seminoncol.2008.04.011. PMID 18692691
- BACKGROUNDSpeck NA, Gilliland DG. Core-binding factors in haematopoiesis and leukaemia. Nat Rev Cancer. 2002 Jul;2(7):502-13. doi: 10.1038/nrc840. No abstract available. PMID 12094236
- BACKGROUNDMarcucci G, Mrozek K, Ruppert AS, Maharry K, Kolitz JE, Moore JO, Mayer RJ, Pettenati MJ, Powell BL, Edwards CG, Sterling LJ, Vardiman JW, Schiffer CA, Carroll AJ, Larson RA, Bloomfield CD. Prognostic factors and outcome of core binding factor acute myeloid leukemia patients with t(8;21) differ from those of patients with inv(16): a Cancer and Leukemia Group B study. J Clin Oncol. 2005 Aug 20;23(24):5705-17. doi: 10.1200/JCO.2005.15.610.