TriangleNCT00648739 · OUTCOME
Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- COUNT_OF_PARTICIPANTS
- Unit
- Participants
- Interval / dispersion
- Not reported
- Time frame
- From first dose through 10 weeks after the last dose
What was measured
Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=\>50% increase for \>2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented.
Analysis population: All participants with B-CLL who received at least 1 dose of samalizumab.
Groups in this outcome
Samalizumab 50 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 100 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 200 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 300 mg/m^2
Participants assigned to this dose cohort received a single IV 300 mg/m\^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 400 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
Samalizumab 500 mg/m^2
Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
| Group | Source count |
|---|---|
| Samalizumab 50 mg/m^2 | 4 |
| Samalizumab 100 mg/m^2 | 5 |
| Samalizumab 200 mg/m^2 | 3 |
| Samalizumab 300 mg/m^2 | 3 |
| Samalizumab 400 mg/m^2 | 3 |
| Samalizumab 500 mg/m^2 | 5 |
Reported measurements
Progressive Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
Partial Response
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Stable Disease
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 4 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 2 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 3 | Not reported | Not reported | Not reported | Not reported |
Not Evaluable
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
ORR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Samalizumab 50 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 100 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 200 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 300 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 400 mg/m^2 | 1 | Not reported | Not reported | Not reported | Not reported |
| Samalizumab 500 mg/m^2 | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 2
- title
- Progressive Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- Partial Response
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 4
- group Id
- OG002
- value
- 2
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 3
- title
- Stable Disease
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 1
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 0
- group Id
- OG005
- value
- 0
- title
- Not Evaluable
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- group Id
- OG004
- value
- 1
- group Id
- OG005
- value
- 0
- title
- ORR
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 3
- group Id
- OG004
- value
- 3
- group Id
- OG005
- value
- 5
- units
- Participants
- description
- Clinical responses assessed using the Modified NCI Working Group Response Criteria. Overall Response Rate (ORR)=percentage of participants who maintained best response for ≥1 month after achieving that best response and having complete response (CR), partial response (PR), nodular partial response (nPR), or stable disease (SD). CR=absence of lymphadenopathy, hepatomegaly, or splenomegaly and normal complete blood count (CBC). PR=≥50% decrease in peripheral lymphocyte count or ≥50% reduction in lymphadenopathy, hepatomegaly, or splenomegaly and normal or 50% improvement over baseline CBC. nPR=CR participants with lymphoid aggregates. Progressive disease (PD)=\>50% increase for \>2 lymph nodes, spleen and/or liver size, or absolute number of circulating lymphocytes; or new lymph nodes. SD=have not achieved CR, PR, or nPR or have not shown PD. Features must be exhibited for ≥1month for CR/PR. Number of participants with individual best response and ORR for each cohort is presented.
- groups
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 50 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG000
- title
- Samalizumab 50 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 100 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG001
- title
- Samalizumab 100 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 200 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG002
- title
- Samalizumab 200 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV 300 mg/m\^2 dose of samalizumab. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG003
- title
- Samalizumab 300 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 400 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG004
- title
- Samalizumab 400 mg/m^2
- description
- Participants assigned to this dose cohort received a single IV dose of samalizumab 500 mg/m\^2. Participants who tolerated the drug and demonstrated at least stable disease received up to 3 additional cycles of samalizumab at the same dose originally received at a minimum of 28-day intervals and beginning no sooner than 6 weeks after the initial dose.
- id
- OG005
- title
- Samalizumab 500 mg/m^2
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- All participants with B-CLL who received at least 1 dose of samalizumab.
- reporting Status
- POSTED
- time Frame
- From first dose through 10 weeks after the last dose
- title
- Clinical Response Of Participants With B-CLL Following Samalizumab Dosing Using Modified NCI Working Group Response Criteria For ORR Rate
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice