TriangleNCT02003625 · OUTCOME
Time to Neutrophil Engraftment After AHSCT
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 6 months after transplantation ( up to 66-72 days after the start of treatment)
What was measured
The median to neutrophil engraftment (absolute neutrophil counts above 0.5/mcl for 3 consecutive days) .
Analysis population: Time to engraftment was only assessed among patients that received transplantation
Groups in this outcome
A. GCSF + Placebo
GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo
B. GCSF + Meloxicam
B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam
| Group | Source count |
|---|---|
| A. GCSF + Placebo | 14 |
| B. GCSF + Meloxicam | 12 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A. GCSF + Placebo | 10 | Not reported | 10 | 12 | Not reported |
| B. GCSF + Meloxicam | 10 | Not reported | 9 | 11 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 10
- upper Limit
- 12
- value
- 10
- group Id
- OG001
- lower Limit
- 9
- upper Limit
- 11
- value
- 10
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 12
- units
- Participants
- description
- The median to neutrophil engraftment (absolute neutrophil counts above 0.5/mcl for 3 consecutive days) .
- dispersion Type
- Full Range
- groups
- description
- GCSF + Placebo Patients in this group will receive GCSF 10 ug/kg s.c. daily, beginning 4 days prior to the 1st apheresis \[days -4, -3, -2, -1\] and continued on daily GCSF for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. They will also receive oral placebo for 5 days on days -6 through -2. Patients will undergo apheresis for 300 minutes to achieve approximately 3 to 4 whole blood volumes processed. This is a standard institutional protocol for autologous HSPC collection at the MGH. GCSF Placebo
- id
- OG000
- title
- A. GCSF + Placebo
- description
- B. GCSF + meloxicam: Patients in this group will be treated with meloxicam and GCSF in an approximate two-day staggered dose schedule as described in our preclinical studies. Meloxicam will be given orally at a dose of 15 mg/day for 5 days (days -6 through -2). GCSF at 10 ug/kg/day subcutaneously will be started on day -4 and continued daily for a total of 4 apheresis or until ≥ 5 x 10\^6 CD34+ cells/kg are collected. GCSF meloxicam
- id
- OG001
- title
- B. GCSF + Meloxicam
- param Type
- MEDIAN
- population Description
- Time to engraftment was only assessed among patients that received transplantation
- reporting Status
- POSTED
- time Frame
- Up to 6 months after transplantation ( up to 66-72 days after the start of treatment)
- title
- Time to Neutrophil Engraftment After AHSCT
- type
- PRIMARY
- unit Of Measure
- Days
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice