TriangleNCT02988466 · OUTCOME
Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- NUMBER
- Unit
- Percentage of participants
- Interval / dispersion
- 95% Confidence Interval
- Time frame
- day 100
What was measured
Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).
Groups in this outcome
Arm A: Haplo-HCT <55 Years Old
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
CLOSED Arm B: Haplo-HCT ≥55 Years Old
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
| Group | Source count |
|---|---|
| Arm A: Haplo-HCT <55 Years Old | 14 |
| CLOSED Arm B: Haplo-HCT ≥55 Years Old | 21 |
| Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo | 8 |
| Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | 35 |
Reported measurements
grade II-IV acute graft versus-host-disease (GVHD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Haplo-HCT <55 Years Old | 21 | Not reported | 1 | 42 | Not reported |
| CLOSED Arm B: Haplo-HCT ≥55 Years Old | 33 | Not reported | 13 | 54 | Not reported |
| Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo | 13 | Not reported | 0 | 34 | Not reported |
| Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | 31 | Not reported | 16 | 47 | Not reported |
grade III-IV acute graft versus-host-disease (GVHD)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A: Haplo-HCT <55 Years Old | 0 | Not reported | 0 | 100 | Not reported |
| CLOSED Arm B: Haplo-HCT ≥55 Years Old | 19 | Not reported | 3 | 36 | Not reported |
| Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo | 0 | Not reported | 0 | 100 | Not reported |
| Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3 | 11 | Not reported | 1 | 22 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 1
- upper Limit
- 42
- value
- 21
- group Id
- OG001
- lower Limit
- 13
- upper Limit
- 54
- value
- 33
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 34
- value
- 13
- group Id
- OG003
- lower Limit
- 16
- upper Limit
- 47
- value
- 31
- title
- grade II-IV acute graft versus-host-disease (GVHD)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 0
- upper Limit
- 100
- value
- 0
- group Id
- OG001
- lower Limit
- 3
- upper Limit
- 36
- value
- 19
- group Id
- OG002
- lower Limit
- 0
- upper Limit
- 100
- value
- 0
- group Id
- OG003
- lower Limit
- 1
- upper Limit
- 22
- value
- 11
- title
- grade III-IV acute graft versus-host-disease (GVHD)
- denoms
- counts
- group Id
- OG000
- value
- 14
- group Id
- OG001
- value
- 21
- group Id
- OG002
- value
- 8
- group Id
- OG003
- value
- 35
- units
- Participants
- description
- Percentage of participants with incidence of grade II-IV and grade III-IV acute graft versus-host-disease (GVHD).
- dispersion Type
- 95% Confidence Interval
- groups
- description
- Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients \<55 years old with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 Haplo HCT \<55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion Day 0 GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
- id
- OG000
- title
- Arm A: Haplo-HCT <55 Years Old
- description
- Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients ≥55 years old or younger with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. Haplo HCT ≥55 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel): Dose reduction by 30% * Total body irradiation (TBI) * Non-T-cell depleted donor bone marrow stem cell infusion GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF)
- id
- OG001
- title
- CLOSED Arm B: Haplo-HCT ≥55 Years Old
- description
- Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≤2 aged ≥55 and \< 65 years old. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥55 and \< 65 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Melphalan (Mel) * Total body irradiation (TBI) * non-T-cell depleted donor bone marrow stem cells
- id
- OG002
- title
- Arm C: Haplo-HCT HCT-CI ≤2 Aged ≥55 and < 65yo
- description
- Reduced-intensity conditioning and transplantation of human leukocyte antigen (HLA) -haploidentical related donor stem cells for patients patients ≥65 and ≤75 years old OR any age group with hematopoietic cell transplantation Comorbidity Index (HCT-CI) ≥3. GVHD Prophylaxis: - Cyclophosphamide (Cy) * Tacrolimus (Tac) * Mycophenolate mofetil (MMF) Haplo HCT ≥65 and ≤75 years old: - Fludarabine (Flu) * Cyclophosphamide (Cy) * Total body irradiation (TBI)
- id
- OG003
- title
- Arm D: Haplo-HCT Aged ≥65 and ≤75yo OR Any Age HCT-CI ≥3
- param Type
- NUMBER
- reporting Status
- POSTED
- time Frame
- day 100
- title
- Incidence of Grade II-IV and Grade III-IV Acute Graft Versus-host-disease (GVHD)
- type
- SECONDARY
- unit Of Measure
- Percentage of participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice