TriangleNCT00578942 · OUTCOME
Overall Survival (OS)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEAN
- Unit
- months alive post-infusion
- Interval / dispersion
- Full Range
- Time frame
- Up to 12 years; participants were followed for the duration of the study, an average of 8 years
What was measured
Estimate overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.
Analysis population: Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death. One participant who was lost to follow-up after 14 months was not included. Participants were followed for the duration of the study, an average of 8 years.
Groups in this outcome
Campath Purged Non-myeloablative ASCT
Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.
| Group | Source count |
|---|---|
| Campath Purged Non-myeloablative ASCT | 47 |
Reported measurements
Source class 1
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Campath Purged Non-myeloablative ASCT | 32 | Not reported | 2 | 123 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 2
- upper Limit
- 123
- value
- 32
- denoms
- counts
- group Id
- OG000
- value
- 47
- units
- Participants
- description
- Estimate overall survival rates in subjects treated with a non-myeloablative preparative regimen followed by matched related allogeneic stem cells for allogeneic transplantation.
- dispersion Type
- Full Range
- groups
- description
- Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized. Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours. Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45.
- id
- OG000
- title
- Campath Purged Non-myeloablative ASCT
- param Type
- MEAN
- population Description
- Subjects who completed CAMPATH regimen + 45 days, until disease progression, or death. One participant who was lost to follow-up after 14 months was not included. Participants were followed for the duration of the study, an average of 8 years.
- reporting Status
- POSTED
- time Frame
- Up to 12 years; participants were followed for the duration of the study, an average of 8 years
- title
- Overall Survival (OS)
- type
- PRIMARY
- unit Of Measure
- months alive post-infusion
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice