TriangleNCT01899326 · OUTCOME
Median Number of Days of Apheresis
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Days
- Interval / dispersion
- Full Range
- Time frame
- Up to 1 week following completion of study treatment, up to 15 days
What was measured
Median number of days of apheresis required to collect \>=5 x 10\^6 CD34+ cells/kg. Standard descriptive statistics were used to summarize the data.
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) | 1.5 | Not reported | 1 | 2 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 2
- value
- 1.5
- denoms
- counts
- group Id
- OG000
- value
- 6
- units
- Participants
- description
- Median number of days of apheresis required to collect \>=5 x 10\^6 CD34+ cells/kg. Standard descriptive statistics were used to summarize the data.
- dispersion Type
- Full 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 Number of Days of Apheresis
- type
- SECONDARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice