TriangleNCT03805932 · OUTCOME
Number of Participants Who Are Minimal Residual Disease (MRD)-Free
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
- 28-42 days after day 1 of the last treatment.
What was measured
MRD-free is defined as participants with no hairy cell leukemia (HCL) in the blood and bone marrow aspirate flow determined by immunohistochemistry (IHC) and flow cytometry of blood and bone marrow aspirate.
Groups in this outcome
Moxetumomab - Dose Escalation 30 mcg/kg
Participants with Relapsed/Refractory Hairy Cell Leukemia (HCL) or Hairy Cell Leukemia (HCLv) Arm 1 Moxetumomab Pasudotox-tdfk + Rituximab Dose escalation treatment with moxetumomab -pasudotox-tdfk and rituximab Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Rituximab will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1.
Moxetumomab - Dose Expansion 40 mcg/kg
Dose expansion; treatment with moxetumomab -pasudotox-tdfk and Ruxience Arm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Ruxience will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Ruxience is given on day -2, on subsequent cycles, Ruxience is given on day 1 (Delta)
| Group | Source count |
|---|---|
| Moxetumomab - Dose Escalation 30 mcg/kg | 3 |
| Moxetumomab - Dose Expansion 40 mcg/kg | 15 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Moxetumomab - Dose Escalation 30 mcg/kg | 2 | Not reported | Not reported | Not reported | Not reported |
| Moxetumomab - Dose Expansion 40 mcg/kg | 11 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 11
- denoms
- counts
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 15
- units
- Participants
- description
- MRD-free is defined as participants with no hairy cell leukemia (HCL) in the blood and bone marrow aspirate flow determined by immunohistochemistry (IHC) and flow cytometry of blood and bone marrow aspirate.
- groups
- description
- Participants with Relapsed/Refractory Hairy Cell Leukemia (HCL) or Hairy Cell Leukemia (HCLv) Arm 1 Moxetumomab Pasudotox-tdfk + Rituximab Dose escalation treatment with moxetumomab -pasudotox-tdfk and rituximab Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Rituximab will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Rituximab is given on day -2, on subsequent cycles, Rituximab is given on day 1.
- id
- OG000
- title
- Moxetumomab - Dose Escalation 30 mcg/kg
- description
- Dose expansion; treatment with moxetumomab -pasudotox-tdfk and Ruxience Arm 1 and Arm 2 Moxetumomab Pasudotox-tdfk + Ruxience Moxetumomab pasudotox-tdfk is administered at 30-40 ug/Kg intravenous (iv) over 30 min given on days 1, 3, 5 of each cycle. Ruxience will be administered at 375mg/m\^2 iv, 50-400 mg/hour (hr). On cycle 1, Ruxience is given on day -2, on subsequent cycles, Ruxience is given on day 1 (Delta)
- id
- OG001
- title
- Moxetumomab - Dose Expansion 40 mcg/kg
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 28-42 days after day 1 of the last treatment.
- title
- Number of Participants Who Are Minimal Residual Disease (MRD)-Free
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice