Phase 2 Completed N=122 Treatment

Clofarabine Plus Low-Dose Cytarabine Induction and Decitabine Consolidation in Frontline Acute Myeloid Leukemia (AML) and High-Risk Myelodysplastic Syndrome (MDS)

Acute Myeloid Leukemia · Myelodysplastic Syndromes

Source: ClinicalTrials.gov NCT00778375 ↗

Enrolled (actual)

122

Serious AEs

10.1%

Results posted

Feb 2016

Primary outcomePrimary: Disease-free (DFS) or Relapse-free Survival (RFS) Time — 15.9 Months

Summary

The goal of this clinical research study is to learn if clofarabine given in combination with cytarabine and decitabine can help to control the disease in patients with AML or MDS who are 60 years old or older. The safety of this treatment will also be studied.

Outcome Measures

Outcome	Result	p-value
PRIMARY Disease-free (DFS) or Relapse-free Survival (RFS) Time	15.9	—
PRIMARY Complete Remission (CR) Rate for First 60 Participants	58	—
PRIMARY Median Overall Survival (OS)	11.1; 21.1	—
PRIMARY Number of Participants With Complete Remission [Complete Response (CR), Complete Response With Platelet Recover (CRp) or Complete Response With Incomplete Marrow Recovery (CRi)]	60; 12; 9; 4	—
SECONDARY Event Free Survival (EFS)	7.7	—
SECONDARY Overall Response Rate (CR, CRp/CRi and PR)	73	—

Eligibility Criteria

Inclusion Criteria

Previously untreated AML and high-risk MDS (>/= 10% blasts or >/= IPSS intermediate-2). Prior therapy with hydroxyurea, biological or targeted therapy (e.g. flt3 inhibitors, other kinase inhibitors, azacitidine), or hematopoietic growth factors is allowed.
Age >/= 60 years.
Eastern Cooperative Oncology Group (ECOG) performance status </= 2.
Adequate hepatic (serum total bilirubin </= 1.5 x ULN, serum glutamate pyruvate transaminase (SGPT) and/or serum glutamate oxaloacetate transaminase (SGOT) </= 2.5 x ULN) and renal function (creatinine </= 1.5 mg/dL).
Sign written informed consent

Exclusion Criteria

Cardiac ejection fraction < 40%.
Prior therapy with clofarabine or decitabine.
Active and uncontrolled disease/infection as judged by the treating physician.
Pregnancy
Acute promyelocytic leukemia (APL).
Women of childbearing potential and men who do not practice contraception.
Women of childbearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00778375). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.