TriangleNCT01010061 · OUTCOME
Percentage of Participants With End of Treatment Response (EOTR)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
What was measured
EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \>1.5 x 10\^9/L, Platelets \>100 x 10\^9/L, Hemoglobin \>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \>1.5 x 10\^9/ or ≥50% increase, Platelets \>100 x 10\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
Analysis population: Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.
Groups in this outcome
Obinutuzumab + Chlorambucil (GClb)
Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
Chlorambucil (Clb)
Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
| Group | Source count |
|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 238 |
| Chlorambucil (Clb) | 118 |
Reported measurements
Complete Response (CR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 17.2 | Not reported | 12.7 | 22.6 | Not reported |
| Chlorambucil (Clb) | 0.0 | Not reported | 0.0 | 3.1 | Not reported |
Complete Response incomplete (CRi)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 4.2 | Not reported | 2 | 7.6 | Not reported |
| Chlorambucil (Clb) | 0.0 | Not reported | 0.0 | 3.1 | Not reported |
Partial Response (PR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 48.3 | Not reported | 41.8 | 54.9 | Not reported |
| Chlorambucil (Clb) | 28.8 | Not reported | 20.8 | 37.9 | Not reported |
Nodular Partial Response (nPR)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 7.6 | Not reported | 4.5 | 11.7 | Not reported |
| Chlorambucil (Clb) | 2.5 | Not reported | 0.5 | 7.3 | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 5 | Not reported | 2.6 | 8.6 | Not reported |
| Chlorambucil (Clb) | 22.9 | Not reported | 15.7 | 31.5 | Not reported |
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 4.2 | Not reported | 2.0 | 7.6 | Not reported |
| Chlorambucil (Clb) | 28.8 | Not reported | 20.8 | 37.9 | Not reported |
No Response Assessment
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Obinutuzumab + Chlorambucil (GClb) | 13.4 | Not reported | NA | NA | 95% CI not estimated. |
| Chlorambucil (Clb) | 16.9 | Not reported | NA | NA | 95% CI not estimated. |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 12.7
- upper Limit
- 22.6
- value
- 17.2
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 3.1
- value
- 0.0
- title
- Complete Response (CR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 7.6
- value
- 4.2
- group Id
- OG001
- lower Limit
- 0.0
- upper Limit
- 3.1
- value
- 0.0
- title
- Complete Response incomplete (CRi)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 41.8
- upper Limit
- 54.9
- value
- 48.3
- group Id
- OG001
- lower Limit
- 20.8
- upper Limit
- 37.9
- value
- 28.8
- title
- Partial Response (PR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 4.5
- upper Limit
- 11.7
- value
- 7.6
- group Id
- OG001
- lower Limit
- 0.5
- upper Limit
- 7.3
- value
- 2.5
- title
- Nodular Partial Response (nPR)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.6
- upper Limit
- 8.6
- value
- 5
- group Id
- OG001
- lower Limit
- 15.7
- upper Limit
- 31.5
- value
- 22.9
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.0
- upper Limit
- 7.6
- value
- 4.2
- group Id
- OG001
- lower Limit
- 20.8
- upper Limit
- 37.9
- value
- 28.8
- title
- Progressive Disease
- categories
- measurements
- comment
- 95% CI not estimated.
- group Id
- OG000
- lower Limit
- NA
- upper Limit
- NA
- value
- 13.4
- comment
- 95% CI not estimated.
- group Id
- OG001
- lower Limit
- NA
- upper Limit
- NA
- value
- 16.9
- title
- No Response Assessment
- denoms
- counts
- group Id
- OG000
- value
- 238
- group Id
- OG001
- value
- 118
- units
- Participants
- description
- EOTR was the first response assessment 56 days from the last dose according to the International Workshop on Chronic Lymphocytic Leukaemia (IWCLL) guidelines. CR required: Peripheral blood lymphocytes below 4 x 10\^9/L, Absence of significant lymphadenopathy, No hepatomegaly, No splenomegaly, Absence of disease, Blood counts above the following values (Neutrophils \>1.5 x 10\^9/L, Platelets \>100 x 10\^9/L, Hemoglobin \>11g/dL) and Bone marrow at least normocellular for age. CRi was CR with incomplete bone marrow recovery. PR required the following for at least 2 months from end of treatment: ≥50% decrease in peripheral blood lymphocyte count from the pre-treatment value AND Either a ≥ 50% reduction in lymphadenopathy OR ≥50% reduction of liver enlargement OR ≥50% reduction of spleen enlargement PLUS at least one of the following: Neutrophils \>1.5 x 10\^9/ or ≥50% increase, Platelets \>100 x 10\^9/L or ≥50% increase, Hemoglobin 11 g/dL or ≥50% increase.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received 1000 mg obinutuzumab intravenous (IV) infusion, on Days 1 \[first infusion split 100 mg on Day 1 and 900 mg on Day 2 as per protocol amendment\], 8 and 15 in Cycle 1 and Day 1 in Cycles 2-6 (28-day cycles) plus chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles).
- id
- OG000
- title
- Obinutuzumab + Chlorambucil (GClb)
- description
- Participants received chlorambucil 0.5 mg/kg orally on Day 1 and 15 of each 28-day cycle (6 Cycles). Participants with Progressive Disease or within 6 months of follow-up were allowed to cross over to receive obinutuzumab + chlorambucil.
- id
- OG001
- title
- Chlorambucil (Clb)
- param Type
- NUMBER
- population Description
- Participants from the Intent-to-treat population (all randomized participants) with data available for analysis. Participants who did not reach the 3 month Follow-up visit at the time of the clinical cutoff are excluded.
- reporting Status
- POSTED
- time Frame
- Randomization to clinical cutoff date of 10 Oct 2017 (median observation 62.5 months from randomization)
- title
- Percentage of Participants With End of Treatment Response (EOTR)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0
Preserved source evidence · Not medical advice