Clinical trial · Interventional
The Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia
A Phase I Feasibility Study Assessing the Role of Maintenance Oral Clofarabine in Older Adults With Acute Myeloid Leukemia
NCT01065545CI-TRIAL-00017453withdrawnPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Due to funding issues.
Summary
Brief summary (as posted)
The purpose of this study is to determine the side effects of the study drug, clofarabine, when given by mouth to patients with acute myeloid leukemia (AML), in remission.
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
- interventionNames
- Drug: Clofarabine
Primary outcomes (1)
- measure
- Determine the maximum tolerated dose of oral clofarabine.
- timeFrame
- at study completion (estimated at 2 years)
Secondary outcomes (1)
- measure
- Measure the relapse-free survival.
- timeFrame
- labs drawn weekly (first cycle) and every other week thereafter until progression
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosis of acute myeloid leukemia, in first or second remission. * Age 55 or older * Patients must have given signed, informed consent prior to registration on study. * Participants must have attained a complete remission (CR) to induction chemotherapy and are not good candidates for further intensive chemotherapy or a transplant. * Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment. * Male and female patients must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment. Exclusion Criteria: * Patients with a diagnosis of acute promyelocytic leukemia are not eligible. * Participants cannot be currently receiving chemotherapy, radiation therapy, or immunotherapy. * Patients must not be receiving any other investigational agents. * Participants cannot have Hepatitis B or C or HIV. * Patients must not have an uncontrolled infection
References
Publications (0)
Data not yet available
No reference posted for this study.