TriangleNCT01899326 · OUTCOME
Median Time to Neutrophil Engraftment
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- number of days
- Interval / dispersion
- Inter-Quartile Range
- Time frame
- Up to 1 week following completion of study treatment, up to 15 days
What was measured
Median time (number of days) to neutrophil engraftment was determined as first of three consecutive days with absolute neutrophil count (ANC) \> 500/ul or first day with ANC \> 1000/ul in the absence of growth factor support.
Analysis population: 6 participants underwent stem cell transplantation and completed the full study protocol.
Groups in this outcome
Treatment (Desipramine, Filgrastim)
Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\^6 cells/kg was reached. If the collected CD34+ cell dose was \<0.5x10\^6 on two consecutive days, aperheris was stopped and the patient was taken off study. Despiramine hydrochloride: PO Filgrastim: PO
| Group | Source count |
|---|---|
| Treatment (Desipramine, Filgrastim) | 6 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Treatment (Desipramine, Filgrastim) | 12 | Not reported | 11.8 | 12 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 11.8
- upper Limit
- 12
- value
- 12
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Median time (number of days) to neutrophil engraftment was determined as first of three consecutive days with absolute neutrophil count (ANC) \> 500/ul or first day with ANC \> 1000/ul in the absence of growth factor support.
- dispersion Type
- Inter-Quartile Range
- groups
- description
- Patients received 100mg desipramine hydrochloride PO daily from Day -3 to Day +4 (8 days total) and filgrastim PO BID from Day +1 to Day +4. Complete blood count (CBC) and peripheral blood CD34+ counts were determined on Day +4 and Day +5. Leukapheresis was started when peripheral blood CD34+ count exceeded 10/uL. If CD34+ counts were \<10/uL on Day +5, plerixafor was added as a salvage therapy. Daily leukapheresis was performed with four times the estimated blood volume during each collection until a target cell dose of at least 5x10\^6 cells/kg was reached. If the collected CD34+ cell dose was \<0.5x10\^6 on two consecutive days, aperheris was stopped and the patient was taken off study. Despiramine hydrochloride: PO Filgrastim: PO
- id
- OG000
- title
- Treatment (Desipramine, Filgrastim)
- param Type
- MEDIAN
- population Description
- 6 participants underwent stem cell transplantation and completed the full study protocol.
- reporting Status
- POSTED
- time Frame
- Up to 1 week following completion of study treatment, up to 15 days
- title
- Median Time to Neutrophil Engraftment
- type
- SECONDARY
- unit Of Measure
- number of days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice