TriangleNCT02048813 · OUTCOME
Progression-free Survival (PFS) Rate at 3 Years
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Proportion of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Assessed every 3 months until progression up to 4 years and 8 months
What was measured
PFS was defined as the time from randomization to CLL progression or death, whichever occurred first. Progression is characterized by any of the following: * ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart * ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen * ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\^9/L to qualify as disease progression. * Transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with \> 55% prolymphocytes). For patients who achieve a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \> 5x10\^9/L and/or recurrence of palpable lymphadenopathy \> 1.5 cm by physical exam.
Analysis population: All randomized patients were included in this analysis.
Groups in this outcome
Arm A (Ibrutinib, Rituximab)
Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
| Group | Source count |
|---|---|
| Arm A (Ibrutinib, Rituximab) | 354 |
| Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 175 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (Ibrutinib, Rituximab) | 0.894 | Not reported | 0.86 | 0.93 | Not reported |
| Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide) | 0.729 | Not reported | 0.653 | 0.813 | Not reported |
Source statistical analyses
- ci Lower Limit
- 0.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.56
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.35
- statistical Method
- Log Rank
Complete source fields
- analyses
- ci Lower Limit
- 0.22
- ci Num Sides
- TWO_SIDED
- ci Pct Value
- 95
- ci Upper Limit
- 0.56
- group Ids
- OG000
- OG001
- non Inferiority Type
- SUPERIORITY
- p Value
- <.001
- param Type
- Hazard Ratio (HR)
- param Value
- 0.35
- statistical Method
- Log Rank
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0.86
- upper Limit
- 0.93
- value
- 0.894
- group Id
- OG001
- lower Limit
- 0.653
- upper Limit
- 0.813
- value
- 0.729
- denoms
- counts
- group Id
- OG000
- value
- 354
- group Id
- OG001
- value
- 175
- units
- Participants
- description
- PFS was defined as the time from randomization to CLL progression or death, whichever occurred first. Progression is characterized by any of the following: * ≥ 50% increase from nadir since start of treatment (tx) in the sum of the products of at least 2 lymph nodes on 2 consecutive examinations 2 weeks apart * ≥ 50% increase from nadir since start of tx in the size of liver and/or spleen * ≥ 50% increase in the absolute number of circulating lymphocytes not due to tumor flare reaction. The absolute lymphocyte count must be ≥ 5x10\^9/L to qualify as disease progression. * Transformation to a more aggressive histology (e.g. Richter's syndrome or prolymphocytic leukemia with \> 55% prolymphocytes). For patients who achieve a complete response or nodular partial response, progression is defined as recurrence of circulating leukemia cell clone in the peripheral blood and an absolute lymphocyte count \> 5x10\^9/L and/or recurrence of palpable lymphadenopathy \> 1.5 cm by physical exam.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Patients receive ibrutinib 420 mg orally (PO) once daily (QD) on days 1-28. Beginning cycle 2, patients also receive rituximab 50 mg/m2 intravenously (IV) over 4 hours on days 1 and 2 of cycle 2, and rituximab 500 mg/m2day 1 of cycles 3-7. Treatment repeats every 28 days for 7 cycles in the absence of unacceptable toxicity. In the absence of disease progression, patients may continue ibrutinib PO QD.
- id
- OG000
- title
- Arm A (Ibrutinib, Rituximab)
- description
- Patients receive rituximab IV over 4 hours on days 1 (50 mg/m2) and 2 (325 mg/m2) of cycle 1, and day 1 (500 mg/m2) of cycles 2-6. Patients also receive fludarabine phosphate at 25 mg/m2 IV over 30 minutes and cyclophosphamide at 250 mg/m2 IV over 30 minutes on days 1-3. Treatment repeats every 28 days for 6 cycles in the absence of unacceptable toxicity.
- id
- OG001
- title
- Arm B (Rituximab, Fludarabine Phosphate, Cyclophosphamide)
- param Type
- NUMBER
- population Description
- All randomized patients were included in this analysis.
- reporting Status
- POSTED
- time Frame
- Assessed every 3 months until progression up to 4 years and 8 months
- title
- Progression-free Survival (PFS) Rate at 3 Years
- type
- PRIMARY
- unit Of Measure
- Proportion of participants
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Preserved source evidence · Not medical advice