Clinical trial · Interventional
Oral Clofarabine Study in Patients With Myelodysplastic Syndrome
Phase II Study of Oral Clofarabine in Myelodysplastic Syndrome (MDS)
NCT00299156CI-TRIAL-00019687completedPhase 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 learn if clofarabine given by mouth on a weekly schedule can help to control MDS. The safety of clofarabine given by mouth will also be studied.
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 |
|---|---|---|---|
| Chronic Myelomonocytic Leukemia | Chronic Myelomonocytic Leukemia | ONTOLOGY_EXACT | 0.98 |
| Myelodysplastic Syndrome | Myelodysplastic Syndrome | 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
- Oral Clofarabine
- description
- 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
- interventionNames
- Drug: Clofarabine
Primary outcomes (1)
- measure
- Participants With a Complete Remission (CR)
- timeFrame
- After 3 courses of treatment, up to 24 weeks.
- description
- Complete Remission (CR): Normalization of the peripheral blood and bone marrow with \<5% bone marrow blasts, a peripheral blood granulocyte count \> (1.0 x 109/ L, and a platelet count \> 100 x 109/L). Partial Remission: as above except for the presence of 6-15% marrow blasts, or 50% reduction if \<15% at start of treatment. Hematologic Improvement: meets all criteria for CR except for platelet recovery to \>100 x 109/L. Clinical Benefit: Platelets increase by 50% and to above 30 x 109/L untransfused (if lower than that pretherapy); or granulocytes increase by 100% and to above 109/L (if lower than that pretherapy); or hemoglobin increase by 2 g/dl; or transfusion independent; or splenomegaly reduction by \> 50%; or monocytosis reduction by \> 50% if pretreatment \> 5 x 109/L.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with MDS and \>/= 5% blasts or IPSS risk intermediate or high; patients with Chronic myelomonocytic leukemia (CMML). 2. No prior intensive chemotherapy or high-dose ara-C (\>/= 1g/m2). 3. Prior biologic therapies, targeted therapies, or single agent chemotherapy allowed. 4. Patients must have been off chemotherapy for 2 weeks prior to entering this study and recovered from the toxic effects of that therapy, unless there is evidence of rapidly progressive disease. 5. Hydroxyurea is permitted for control of counts prior to treatment. 6. Procrit, GCSF are allowed before therapy. 7. Performance 0-2 (ECOG). Adequate organ function including the following:Adequate liver function (bilirubin of \< 2mg/dl), and renal function (creatinine \< 2mg/dl), and SGPT (ALT) \< 3 X ULN. Adequate cardiac functions (NYHA cardiac III-IV excluded). 8. Signed informed consent. Exclusion Criteria: 1. Nursing and pregnant females. Patients of childbearing potential should practice effective methods of contraception. Child bearing potential defined as not post-menopausal for 12 months or no previous surgical sterilization. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. 2. Active and uncontrolled infections. 3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or psychiatric illness/social situations that would limit compliance with study requirements. 4. Prior clofarabine treatment.
References
Publications (0)
Data not yet available
No reference posted for this study.