TriangleNCT01384513 · OUTCOME
Lymphoid Reconstitution
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- Not reported
- Unit
- Not reported
- Interval / dispersion
- Not reported
- Time frame
- 100 days post-transplant
What was measured
To evaluate lymphoid reconstitution in patients treated on the Two Step approach
Analysis population: This outcome measure was prespecified in the protocol; however, no data were collected because the required assessments were not implemented during study conduct due to logistical and operational constraints. As these assessments were not performed at any time during the study, no data exist and none will become available in the future. Therefore, this outcome cannot be analyzed or reported.
Groups in this outcome
Treatment (Allogeneic PBSCT)
REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
| Group | Source count |
|---|---|
| Treatment (Allogeneic PBSCT) | 0 |
Reported measurements
No numerical measurement classes were posted for this outcome. Missing is not zero.
Complete source fields
- denoms
- counts
- group Id
- OG000
- value
- 0
- units
- Participants
- description
- To evaluate lymphoid reconstitution in patients treated on the Two Step approach
- groups
- description
- REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 60 minutes on days -11 to -8 and busulfan IV over 3 hours on days -10 to -9. Patients undergo TBI on day -6. Patients also receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo DLI on day -6 and CD-34+ allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV or PO with taper beginning on day 42. Patients also receive mycophenolate mofetil IV BID on days -1 to 28. Fludarabine: Given IV Busulfan: Given IV Total Body Irradiation (TBI): 2 Gy administered as part of the conditioning regimen Donor Lymphocyte Infusion (DLI): Undergo DLI Cyclophosphamide (CY): Given IV Tacrolimus: Given IV or PO Mycophenolate mofetil: Given IV Allogeneic hematopoietic stem cell transplantation: Undergo CD34+ allogeneic PBSCT Peripheral blood stem cell transplantation (PBSCT): Undergo CD34+ allogeneic PBSCT
- id
- OG000
- title
- Treatment (Allogeneic PBSCT)
- population Description
- This outcome measure was prespecified in the protocol; however, no data were collected because the required assessments were not implemented during study conduct due to logistical and operational constraints. As these assessments were not performed at any time during the study, no data exist and none will become available in the future. Therefore, this outcome cannot be analyzed or reported.
- reporting Status
- POSTED
- time Frame
- 100 days post-transplant
- title
- Lymphoid Reconstitution
- type
- SECONDARY
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice