NCT03480360 · OUTCOME
Number of Participants Who Experienced Treatment-Related Mortality Within the First 100 Days
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 post-peripheral blood transplant
What was measured
Define subjects who experienced treatment-related mortality within the first 100 days post-peripheral blood transplant
Groups in this outcome
Johns Hopkins' Conditioning Regimen
Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant Cyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4) Fludarabine: 30 mg/m2 daily for 5 days Total Body Irradiation: 200 centigray (cGy) for one day (day -1) Tacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180. cellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation. g-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days. Peripheral Blood Transplant: cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight
| Group | Source count |
|---|---|
| Johns Hopkins' Conditioning Regimen | 20 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Johns Hopkins' Conditioning Regimen | 2 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 2
- denoms
- counts
- group Id
- OG000
- value
- 20
- units
- Participants
- description
- Define subjects who experienced treatment-related mortality within the first 100 days post-peripheral blood transplant
- groups
- description
- Cyclophosphamide, fludarabine, total body irradiation, immune suppression including tacrolimus and cellcept, Granulocyte colony-stimulating factor (G-CSF), and peripheral blood transplant Cyclophosphamide: 14.5 mg/kg for 2 days (days -6, -5) and then 50 mg/kg for two days (days 3, 4) Fludarabine: 30 mg/m2 daily for 5 days Total Body Irradiation: 200 centigray (cGy) for one day (day -1) Tacrolimus: 1 mg IV daily, (or the oral equivalent) adjusted to achieve a level between 5 and 15 ng/ml. If there is no evidence of GVHD, discontinue Tacrolimus by Day 180. cellcept: dose at 15 mg/kg po three times per day (maximum dose of 3 grams/day). Stop Cellcept at Day 35 following transplantation. g-csf: 5 mcg/kg/d starting day 5 and continue until Absolute Neutrophil Count (ANC) \> 1000/mcL for 3 days. Peripheral Blood Transplant: cell dose goal: \< 5 x 106 Hematopoietic progenitor cell antigen CD34+ cells/kg recipient weight
- id
- OG000
- title
- Johns Hopkins' Conditioning Regimen
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 100 days post-peripheral blood transplant
- title
- Number of Participants Who Experienced Treatment-Related Mortality Within the First 100 Days
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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