Clinical trial · Interventional
Clofarabine, Idarubicin, and Cytarabine Combination in Acute Myeloid Leukemia (AML) Induction
Clofarabine, Idarubicin, and Cytarabine Combination as Induction Therapy for Younger Patients With Acute Myeloid Leukemia (AML)
NCT01025154CI-TRIAL-00035188completedPhase 2Results postedClinicalTrials.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)
The goal of this clinical research study is to learn if the combination of clofarabine, cytarabine, and idarubicin can help to control Acute Myeloid Leukemia (AML) in patients who are between the ages of 18 and 60 years old. The safety of this study drug combination will also be studied.
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 (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Clofarabine | Drug | Clofarabine | ALIAS |
| Cytarabine | Drug | Cytarabine | ALIAS |
| Idarubicin | Drug | Idarubicin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine, Cytarabine + Idarubicin
- description
- Induction Cycle: Clofarabine 20 mg/m\^2 intravenous (IV) daily for 5 days; Idarubicin 10 mg/m\^2 IV daily for 3 days; Cytarabine 1 g/m\^2 IV daily for 5 days
- interventionNames
- Drug: Clofarabine
- Drug: Idarubicin
- Drug: Cytarabine
Primary outcomes (2)
- measure
- Overall Response: Number of Participants With Complete Remission or Complete Remission Without Platelet Recovery
- timeFrame
- 8 weeks after Induction therapy (induction cycle 4-6 weeks)
- description
- Overall Response (CR+CRp) defined as Complete remission (CR): Disappearance of all clinical and/or radiologic evidence of disease. Neutrophil count \> 1.0 x 10\^9/L and platelet count \> 100 x 10\^9/L, and normal bone marrow differential (\< 5% blasts); and, Complete Remission without Platelet Recovery (CRp): Peripheral blood and bone marrow results as for CR, but with platelet counts of \< 100 x 10\^9/L. Response evaluated within 8 weeks after induction therapy.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: 1. Diagnosis of AML (World Health Organization (WHO) classification) 2. Patients must be chemotherapy-naïve, i.e. not have received any prior cytotoxic chemotherapy for AML (with the exception of hydroxyurea). They could have received prior therapy with hypomethylating agents, targeted, or biological agents. 3. Age 18 to 60 years. 4. Eastern Cooperative Oncology Group (ECOG) performance status \</= 2. 5. Serum creatinine \</= 1.0 mg/dL; if serum creatinine \> 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be \> 60 mL/min/1.73m\^2 as calculated by the Modification of Diet in Renal Disease equation where Predicted GFR (ml/min/1.73m\^2)=186 \* (serum creatinine)\^-1.154 x (age in years)\^-0.023 \* (0.742 if patient is female) \* (1.212 if patient is black), where SCr is serum creatinine measured in mg/dL. serum bilirubin \</= 1.5 \* upper limit of normal (ULN) (unless increase is due to hemolysis or a congenital disorder); serum transaminases (SGPT and/or SGOT) \</= 2.5 \* ULN. 6. Cardiac ejection fraction \>/= 45% (by either echocardiography or MUGA scan). 7. Ability to understand and provide signed informed consent. Exclusion Criteria: 1. Patients with acute promyelocytic leukemia (APL). 2. Any coexisting medical condition that in the judgment of the treating physician is likely to interfere with study procedures or results. 3. Nursing women, women of childbearing potential with positive urine pregnancy test, or women of childbearing potential who are not willing to maintain adequate contraception (such as birth control pills, intrauterine device (IUD), diaphragm, abstinence, or condoms by their partner) over the entire course of therapy. 4. Active and uncontrolled infection requiring therapy with IV antibiotics or antifungal therapy. Prior or concurrent history of one or more opportunistic infections (e.g., cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB).
References
Publications (1)
- DERIVEDMorita K, Kantarjian HM, Wang F, Yan Y, Bueso-Ramos C, Sasaki K, Issa GC, Wang S, Jorgensen J, Song X, Zhang J, Tippen S, Thornton R, Coyle M, Little L, Gumbs C, Pemmaraju N, Daver N, DiNardo CD, Konopleva M, Andreeff M, Ravandi F, Cortes JE, Kadia T, Jabbour E, Garcia-Manero G, Patel KP, Futreal PA, Takahashi K. Clearance of Somatic Mutations at Remission and the Risk of Relapse in Acute Myeloid Leukemia. J Clin Oncol. 2018 Jun 20;36(18):1788-1797. doi: 10.1200/JCO.2017.77.6757. Epub 2018 Apr 27. PMID 29702001