TriangleNCT00741455 · OUTCOME
Number of Participants With Successful Bone Marrow Engraftment
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
- Within 30 days of bone marrow transplant
What was measured
Rates of successful engraftment.
Groups in this outcome
Study Treatment
Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml. G-CSF: 10 mcg/k
| Group | Source count |
|---|---|
| Study Treatment | 17 |
Reported measurements
Engrafted </= 15 Days
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Study Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
Engrafted 16-30 Days
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Study Treatment | 15 | Not reported | Not reported | Not reported | Not reported |
Engrafted >30 Days
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Study Treatment | 1 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Engrafted </= 15 Days
- categories
- measurements
- group Id
- OG000
- value
- 15
- title
- Engrafted 16-30 Days
- categories
- measurements
- group Id
- OG000
- value
- 1
- title
- Engrafted >30 Days
- denoms
- counts
- group Id
- OG000
- value
- 17
- units
- Participants
- description
- Rates of successful engraftment.
- groups
- description
- Chemo, stem cell transplantation, HLA-Matched related allogeneic stem cell transplantation, leukapheresis, G-CSF, peripheral blood stem cell transplant, fludarabine, cyclophosphamide, donor lymphocyte infusion, cyclosporine, methotrexate Stem Cell Transplant: Donor: Prior to mobilization, leukapheresis to collect CD3+ cells. The donor will then receive G-CSF (10 mcg/kg/day) with leukapheresis collection of peripheral blood stem cells on days 5, 6 and 7 as needed. Goal of leukapheresis will be \> 5 x 106 CD34+cells/kg of recipient. Patient: Peripheral Blood Stem Cell (PBSC) Transplant. Fludarabine 25mg/m2/d IV over 30 minutes on days -6 to -2, followed by cyclophosphamide 1g/m2/d IV on days -3 and -2. This will be followed by allogeneic stem cell infusion 48 hours later. Donor Lymphocyte Infusion (DLI) and Adjustment of Immunosuppression: Cyclosporine (CSA) and methotrexate (MTX) will be used for GvHD prophylaxis with target CSA levels of 200-400 ng/ml. G-CSF: 10 mcg/k
- id
- OG000
- title
- Study Treatment
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- Within 30 days of bone marrow transplant
- title
- Number of Participants With Successful Bone Marrow Engraftment
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice