Phase 2
Completed N=69
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
Source: ClinicalTrials.gov NCT00924443 ↗Enrolled (actual)
69
Serious AEs
60.6%
Results posted
Apr 2015
Primary outcomePrimary: Overall Response Rate (ORR) — 48 percentage of participants
Summary
The purpose of the study is to determine if treatment of older patients indicated with untreated Acute Myeloid Leukemia (AML) who are not considered to be suitable for intensive chemotherapy, can effectively be treated with Clofarabine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Response Rate (ORR) |
48 | — |
| SECONDARY Rate of Response (Complete, Complete With Incomplete Blood Count Recovery, Partial) |
21; 23; 5 | — |
| SECONDARY Duration of Overall Response |
62 | — |
| SECONDARY Overall Survival |
173 | — |
| SECONDARY Duration of Complete Remission |
63 | — |
Eligibility Criteria
Inclusion Criteria
- Provide signed, written informed consent
- Have untreated AML according to World Health Organization (WHO) classification
- Male or post-menopausal female ≥ 65 years of age
- Unsuitable for intensive chemotherapy
- Be able to comply with study procedures and follow-up examination
- Male patient who are fertile agree to use and effective barrier method of birth control to avoid pregnancies
- Have adequate liver and renal function as indicated by certain laboratory values
Exclusion Criteria
- Received previous treatment with clofarabine
- Are receiving other chemotherapy or corticosteroids (low-dose corticosteroid for pre-medication purposes are allowed)
- Have received prior treatment for leukemia. Growth factor, cytokine support, leukopheresis or hydroxyurea will be allowed but must be discontinued at least 24 hours prior to start of treatment with clofarabine
- Have a psychiatric disorder that would interfere with consent, study participation, or follow-up
- Have an active, uncontrolled systemic infection
- Are currently participating in other investigational drug studies or having received other investigational drugs within the previous 30 days
- Have symptomatic central nervous system (CNS) involvement
- Blast transformation of chronic myeloid leukemia or acute promyelocytic leukemia
Data sourced from ClinicalTrials.gov (NCT00924443). 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.