TriangleNCT04552743 · OUTCOME
Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L]
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
- 100 days
What was measured
Maintenance of successful engraftment after initial engraftment is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants with successful neutrophil engraftment \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\], the outcome is reported as the number of participants that had maintained successful graft status \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\] at 30 days and 100 days after the infusion. The outcome is a number without dispersion.
Analysis population: This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure, and with successful neutrophil engraftment.
Groups in this outcome
MGTA-145 and Plerixafor HSC Mobilization
Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
| Group | Source count |
|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 19 |
Reported measurements
ANC ≥ 0.5 x 10e9/L at 30 days
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 19 | Not reported | Not reported | Not reported | Not reported |
ANC ≥ 0.5 x 10e9/L at 100 days
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| MGTA-145 and Plerixafor HSC Mobilization | 19 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 19
- title
- ANC ≥ 0.5 x 10e9/L at 30 days
- categories
- measurements
- group Id
- OG000
- value
- 19
- title
- ANC ≥ 0.5 x 10e9/L at 100 days
- denoms
- counts
- group Id
- OG000
- value
- 19
- units
- Participants
- description
- Maintenance of successful engraftment after initial engraftment is an important assessment of the value of the mobilization and hematopoietic stem cells (HSC) infusion procedure. For participants with successful neutrophil engraftment \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\], the outcome is reported as the number of participants that had maintained successful graft status \[absolute neutrophil count (ANC) ≥ 0.5 x 10e9/L\] at 30 days and 100 days after the infusion. The outcome is a number without dispersion.
- groups
- description
- Patients after screening will undergo baseline evaluation during the premobilization phase up to 30 days before mobilization. Patients will undergo sequential administration of plerixafor 0.24 mg/kg subcutaneously followed 2 hours later by MGTA-145 at 0.03 mg/kg intravenously (3 to10 minute infusion). This will be followed by apheresis. A second day of mobilization and apheresis will be pursued in patients who have not collected 6.0 x 106 CD34+ cells/kg in one session. MGTA-145: A chemokine receptor type 2 (CXCR2) agonist protein, administered via intravenous (IV) infusion over 3 to 10 minutes. Plerixafor: An azamacrocycle CXCR4 chemokine receptor antagonist, administered at 0.24 mg/kg subcutaneously, reduced to 0.16 mg/kg in patients with renal dysfunction (per package insert).
- id
- OG000
- title
- MGTA-145 and Plerixafor HSC Mobilization
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- This outcome is limited to participants that proceeded to the hematopoietic stem cell (HSC) infusion procedure, and with successful neutrophil engraftment.
- reporting Status
- POSTED
- time Frame
- 100 days
- title
- Maintenance of Neutrophil Engraftment [Absolute Neutrophil Count (ANC) ≥ 0.5 x 10e9/L]
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice