TriangleNCT00708721 · OUTCOME
The Overall Response Rate in Response to Low Dose Daily Oral Clofarabine in Patients With High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (Dysplastic Type).
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- participants who experienced a response
- Interval / dispersion
- Not reported
- Time frame
- 4 weeks
What was measured
Response rate was measured as complete, partial and hematologic improvement by modified IWG criteria. For complete remission the following must be present for four weeks in a bone marrow aspirate and biopsy: \<5% myeloblasts, normal maturation of all cell lines, persisted dysplasia. Peripheral blood counts need to be hemoglobin \>11 g/dL, neutrophils \>1000/mm3, platelets\>100000/mm3, blasts 0%. Partial remission requires all criteria for complete remission except blasts decreased by \>50% over pretreatment. Stable disease is defined as failure to achieve at least partial remission, but no evidence of progression for \> 8 weeks. Failure is defined as death during tre3atment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment.
Analysis population: Two patients were not eligible for analysis.
Groups in this outcome
All Evaluable Patients
All participants enrolled. Clofarabine: Clofarabine is a rationally designed, second generation purine nucleoside analogue. Clofarabine was designed as a hybrid molecule to overcome the limitations and incorporate the best qualities of both fludarabine (F-ara-A) and cladribine (2-CdA, CdA) both of which are currently approved by various regulatory authorities for treatment of hematologic malignancies.
| Group | Source count |
|---|---|
| All Evaluable Patients | 9 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| All Evaluable Patients | 3 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 3
- denoms
- counts
- group Id
- OG000
- value
- 9
- units
- Participants
- description
- Response rate was measured as complete, partial and hematologic improvement by modified IWG criteria. For complete remission the following must be present for four weeks in a bone marrow aspirate and biopsy: \<5% myeloblasts, normal maturation of all cell lines, persisted dysplasia. Peripheral blood counts need to be hemoglobin \>11 g/dL, neutrophils \>1000/mm3, platelets\>100000/mm3, blasts 0%. Partial remission requires all criteria for complete remission except blasts decreased by \>50% over pretreatment. Stable disease is defined as failure to achieve at least partial remission, but no evidence of progression for \> 8 weeks. Failure is defined as death during tre3atment or disease progression characterized by worsening of cytopenias, increase in percentage of bone marrow blasts, or progression to a more advanced MDS FAB subtype than pretreatment.
- groups
- description
- All participants enrolled. Clofarabine: Clofarabine is a rationally designed, second generation purine nucleoside analogue. Clofarabine was designed as a hybrid molecule to overcome the limitations and incorporate the best qualities of both fludarabine (F-ara-A) and cladribine (2-CdA, CdA) both of which are currently approved by various regulatory authorities for treatment of hematologic malignancies.
- id
- OG000
- title
- All Evaluable Patients
- param Type
- NUMBER
- population Description
- Two patients were not eligible for analysis.
- reporting Status
- POSTED
- time Frame
- 4 weeks
- title
- The Overall Response Rate in Response to Low Dose Daily Oral Clofarabine in Patients With High Risk Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia (Dysplastic Type).
- type
- PRIMARY
- unit Of Measure
- participants who experienced a response
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice