TriangleNCT01829711 · OUTCOME
Percentage of Participants With MRD Positive or MRD Negative CR by Investigator's Assessment
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
- Prior to each treatment cycle, end of treatment, and at follow-up visits every 3 months for the next 24 months and every 6 months thereafter (Approximately 6 years)
What was measured
The MRD status by investigator refers to results of investigator assessment of bone marrow biopsy or bone marrow aspirate by immunohistochemistry and/or flow cytometry. The CR with Positive or Negative MRD requires all of the following to be present: * No evidence of leukemic cells in the peripheral blood and/or by routine H/E staining of bone marrow. Minimal Residual Disease: CR with HCL evident in blood or marrow by flow cytometry. * Resolution of any hepatomegaly, splenomegaly, and abnormal (\>= 2 cm minimum length) lymphadenopathy by CT or MRI. Although a normal spleen size is not defined, the maximum diameter of the spleen should be either \< 17 cm or have decreased by \>25% from its baseline. * Normal CBC as exhibited by: Neutrophils \>= 1.5 x 10\^9/L, Platelets \>= 100 x 10\^9/L, and hemoglobin \>= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.
Analysis population: The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.
Groups in this outcome
Moxetumomab Pasudotox 40 µg/kg
Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
| Group | Source count |
|---|---|
| Moxetumomab Pasudotox 40 µg/kg | 80 |
Reported measurements
MRD negative CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Moxetumomab Pasudotox 40 µg/kg | 32.5 | Not reported | 22.4 | 43.9 | Not reported |
MRD positive CR
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Moxetumomab Pasudotox 40 µg/kg | 7.5 | Not reported | 2.8 | 15.6 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 22.4
- upper Limit
- 43.9
- value
- 32.5
- title
- MRD negative CR
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2.8
- upper Limit
- 15.6
- value
- 7.5
- title
- MRD positive CR
- denoms
- counts
- group Id
- OG000
- value
- 80
- units
- Participants
- description
- The MRD status by investigator refers to results of investigator assessment of bone marrow biopsy or bone marrow aspirate by immunohistochemistry and/or flow cytometry. The CR with Positive or Negative MRD requires all of the following to be present: * No evidence of leukemic cells in the peripheral blood and/or by routine H/E staining of bone marrow. Minimal Residual Disease: CR with HCL evident in blood or marrow by flow cytometry. * Resolution of any hepatomegaly, splenomegaly, and abnormal (\>= 2 cm minimum length) lymphadenopathy by CT or MRI. Although a normal spleen size is not defined, the maximum diameter of the spleen should be either \< 17 cm or have decreased by \>25% from its baseline. * Normal CBC as exhibited by: Neutrophils \>= 1.5 x 10\^9/L, Platelets \>= 100 x 10\^9/L, and hemoglobin \>= 11.0 g/dL without transfusions or growth factors for at least 4 weeks.
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Participants received intravenous infusion of moxetumomab pasudotox 40 µg/kg on Days 1, 3, and 5 of each 28-day cycle for up to 6 cycles, until documentation of complete response, progressive disease, initiation of alternate therapy, or unacceptable toxicity.
- id
- OG000
- title
- Moxetumomab Pasudotox 40 µg/kg
- param Type
- NUMBER
- population Description
- The ITT population included participants who entered into the study and treated with moxetumomab pasudotox.
- reporting Status
- POSTED
- time Frame
- Prior to each treatment cycle, end of treatment, and at follow-up visits every 3 months for the next 24 months and every 6 months thereafter (Approximately 6 years)
- title
- Percentage of Participants With MRD Positive or MRD Negative CR by Investigator's Assessment
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice