NCT00719849 · OUTCOME
Chimerism
Donor Umbilical Cord Blood Transplant in Treating Patients With Advanced Hematological Cancer or Other Disease · Source last updated 2017-06-14
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
- 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant
What was measured
Count of participants who experienced dominance of one cord blood unit (defined by \>or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.
Groups in this outcome
Cyclophosphamide/Fludarabine/TBI
Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
Cyclophosphamide/Fludarabine/TBI/ATG
Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
| Group | Source count |
|---|
| Cyclophosphamide/Fludarabine/TBI | 4 |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 8 |
|---|
Reported measurements
Day 7
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 14
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 0 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 21
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 28
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 56
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 5 | Not reported | Not reported | Not reported | Not reported |
|---|
Day 80
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 1 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 6 | Not reported | Not reported | Not reported | Not reported |
|---|
6 months
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
1 year
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
2 years
Values in Participants · Interval/dispersion: Not reported| Group | Value | Spread | Lower | Upper | Comment |
|---|
| Cyclophosphamide/Fludarabine/TBI | 2 | Not reported | Not reported | Not reported | Not reported |
|---|
| Cyclophosphamide/Fludarabine/TBI/ATG | 7 | Not reported | Not reported | Not reported | Not reported |
|---|
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Day 7
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- title
- Day 14
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 1
- title
- Day 21
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- title
- Day 28
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 5
- title
- Day 56
- categories
- measurements
- group Id
- OG000
- value
- 1
- group Id
- OG001
- value
- 6
- title
- Day 80
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- title
- 6 months
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- title
- 1 year
- categories
- measurements
- group Id
- OG000
- value
- 2
- group Id
- OG001
- value
- 7
- title
- 2 years
- denoms
- counts
- group Id
- OG000
- value
- 4
- group Id
- OG001
- value
- 8
- units
- Participants
- description
- Count of participants who experienced dominance of one cord blood unit (defined by \>or= 95% contribution of one cord blood unit to BM and all PB fractions -- CD3+, CD33+, CD56+, and CD19+) at 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant.
- groups
- description
- Subjects with hematological malignancies with prior autologous transplant, \>2 cycles of multiagent chemotherapy, or severely immune suppressive therapy in last 3 months, OR subjects with refractory leukemia and lymphoma in aplasia after induction chemotherapy or radioimmunoconjugated monoclonal antibody therapy.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
- id
- OG000
- title
- Cyclophosphamide/Fludarabine/TBI
- description
- Subjects with hematological malignancies with prior autologous transplant \>12 mos or \<1 cycle of multiagent chemotherapy or NO immune suppressive chemotherapy in last 3 months.
* Cyclophosphamide 50 mg/Kg Day -6
* Fludarabine 40mg/m2 Days -6 to -2
* TBI 200 cGy Day -1
* Equine ATG 30mg/Kg Days -6 to -4
Immune suppression: begin Day -3 cyclosporine and mycophenolate mofetil
- id
- OG001
- title
- Cyclophosphamide/Fludarabine/TBI/ATG
- param Type
- COUNT_OF_PARTICIPANTS
- reporting Status
- POSTED
- time Frame
- 7 days, 14 days, 21 days, 28 days, 56 days, and 80 days, 6 months, 1 and 2 years post transplant
- title
- Chimerism
- type
- SECONDARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice
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