Clinical trial · Interventional
Clofarabine vs Clofarabine in Plus With Low-Dose Ara-C in Previously Untreated Patients With Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndromes (MDS).
Randomized Phase II Study of Clofarabine Alone Versus Clofarabine in Combination With Low-Dose Cytarabine in Previously Untreated Patients >= 60 Years With AML and High-Risk MDS
NCT00088218CI-TRIAL-00007765completedPhase 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 study how effective treatments with clofarabine alone and clofarabine given in combination with ara-C are in the treatment of leukemia and high-risk myelodysplastic syndrome (MDS) in patients who are 60 years or older. The safety of these treatments will also be compared.
Conditions
Conditions (2)
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 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ara-C | Drug | Cytarabine | ALIAS |
| Clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Clofarabine
- description
- Clofarabine intravenous (IV) 30 mg/m\^2 daily times 5 days
- interventionNames
- Drug: Clofarabine
- type
- ACTIVE_COMPARATOR
- label
- Clofarabine Plus Ara-C
- description
- Clofarabine IV 30 mg/m\^2 daily times 5 days + Ara-C 20 mg/m\^2 subcutaneously daily times 14 days.
- interventionNames
- Drug: Clofarabine
- Drug: Ara-C
Primary outcomes (1)
- measure
- Number of Participants With Response
- timeFrame
- Every 2 to 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Previously untreated AML and high-risk MDS ( \> 10% blasts, or International Prognostic Scoring System (IPSS) intermediate-2). Prior therapy with hydroxyurea, single agent chemotherapy (e.g. decitabine), hematopoietic growth factors, biological or "targeted" therapies are allowed. * Age \> 60 years. * Eastern Cooperative Oncology Group (ECOG) performance status \</= 2. * Sign a written informed consent form. * Adequate liver function (total bilirubin \< 2mg/dL,serum glutamic pyruvic transaminase (SGPT) or Serum glutamic oxaloacetic transaminase (SGOT) \< x 4 upper limit of normal (ULN)) and renal function (serum creatinine \< 2mg/dL). Exclusion Criteria: * Patients with \>= New York Heart Association (NYHA) grade 3 heart disease as assessed by history and/or physical examination.
References
Publications (1)
- DERIVEDFaderl S, Ravandi F, Huang X, Garcia-Manero G, Ferrajoli A, Estrov Z, Borthakur G, Verstovsek S, Thomas DA, Kwari M, Kantarjian HM. A randomized study of clofarabine versus clofarabine plus low-dose cytarabine as front-line therapy for patients aged 60 years and older with acute myeloid leukemia and high-risk myelodysplastic syndrome. Blood. 2008 Sep 1;112(5):1638-45. doi: 10.1182/blood-2007-11-124602. Epub 2008 Jun 18. PMID 18565853