TriangleNCT00299156 · OUTCOME
Participants With a Complete Remission (CR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- After 3 courses of treatment, up to 24 weeks.
What was measured
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.
Groups in this outcome
Oral Clofarabine
Original dose of 40 mg oral reduced to 30mg and than lower dose of either 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.
Randomized, Oral Clofarabine 10mg
Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
Randomized, Oral Clofarabine 20mg
Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
| Group | Source count |
|---|---|
| Oral Clofarabine | 32 |
| Randomized, Oral Clofarabine 10mg | 16 |
| Randomized, Oral Clofarabine 20mg | 16 |
Reported measurements
Complete Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Clofarabine | 8 | Not reported | Not reported | Not reported | Not reported |
| Randomized, Oral Clofarabine 10mg | 3 | Not reported | Not reported | Not reported | Not reported |
| Randomized, Oral Clofarabine 20mg | 0 | Not reported | Not reported | Not reported | Not reported |
Partial Remission
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Clofarabine | 0 | Not reported | Not reported | Not reported | Not reported |
| Randomized, Oral Clofarabine 10mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Randomized, Oral Clofarabine 20mg | 0 | Not reported | Not reported | Not reported | Not reported |
Hematologic Improvement
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Clofarabine | 3 | Not reported | Not reported | Not reported | Not reported |
| Randomized, Oral Clofarabine 10mg | 1 | Not reported | Not reported | Not reported | Not reported |
| Randomized, Oral Clofarabine 20mg | 3 | Not reported | Not reported | Not reported | Not reported |
Clinical Benefit
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Oral Clofarabine | 3 | Not reported | Not reported | Not reported | Not reported |
| Randomized, Oral Clofarabine 10mg | 0 | Not reported | Not reported | Not reported | Not reported |
| Randomized, Oral Clofarabine 20mg | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 3
- group Id
- OG002
- value
- 0
- title
- Complete Remission
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Partial Remission
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 3
- title
- Hematologic Improvement
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- title
- Clinical Benefit
- denoms
- counts
- group Id
- OG000
- value
- 32
- group Id
- OG001
- value
- 16
- group Id
- OG002
- value
- 16
- units
- Participants
- 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.
- groups
- description
- Original dose of 40 mg oral reduced to 30mg and than lower dose of either 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.
- id
- OG000
- title
- Oral Clofarabine
- description
- Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
- id
- OG001
- title
- Randomized, Oral Clofarabine 10mg
- description
- Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
- id
- OG002
- title
- Randomized, Oral Clofarabine 20mg
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- After 3 courses of treatment, up to 24 weeks.
- title
- Participants With a Complete Remission (CR)
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice