TriangleNCT03480360 · OUTCOME
Immune Checkpoint Regulators - Prevalence
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
- Days 30, 60, and 90 post-transplant
What was measured
To characterize the prevalence of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell transplant.
Analysis population: Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.
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 | 0 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Johns Hopkins' Conditioning Regimen | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- To characterize the prevalence of immune checkpoint regulators (VISTA, CTLA-4, PD-1) during early immune recovery following an allogeneic stem cell 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
- population Description
- Blood samples were collected, however laboratory analysis was not performed due to lack of funding. There are no plans to potentially analyze the samples in the future, therefore these samples were not, and will not be, analyzed.
- reporting Status
- POSTED
- time Frame
- Days 30, 60, and 90 post-transplant
- title
- Immune Checkpoint Regulators - Prevalence
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice