Clinical trial · Interventional
A Study of Clofarabine in Older Patients With Acute Myeloid Leukemia (AML) for Whom Chemotherapy Is Not Suitable
A Phase II Trial of Clofarabine in Older Patients With Acute Myeloid Leukemia for Whom Intensive Chemotherapy is Not Considered Suitable
NCT00924443CI-TRIAL-00017340completedPhase 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 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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| clofarabine | Drug | Clofarabine | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Clofarabine
- description
- Clofarabine 30 mg/m\^2/day intravenously over 1 hour for 5 days every 28 to 42 days (one cycle), then 20mg/m\^2/day intravenously over 1 hour for 5 days every 29 to 43 days for the second and subsequent cycles, up to a maximum of 3 cycles.
- interventionNames
- Drug: clofarabine
Primary outcomes (1)
- measure
- Overall Response Rate (ORR)
- timeFrame
- At month 20
- description
- ORR rate was defined as the sum of the number of participants in the study population with complete remission (CR), complete remission with incomplete blood count recovery (CRi), or partial remission (PR) divided by the total number of participants in the study population. ORR rate was determined by assessment of morphology and blast count from bone marrow aspirates and peripheral blood performed prior to first dose and at the end of clofarabine treatment. The ORR was determined at the end of each cycle of clofarabine, and assessed using the participant's best response to clofarabine treatment.
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 65 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.