TriangleNCT02220985 · OUTCOME
Chronic GVHD
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
- Up to 5 years post-transplant
What was measured
Occurrence of chronic graft-versus-host disease (GHVD), defined operationally as the occurrence of compatible symptoms meeting National Institutes of Health criteria and requiring systemic pharmacological immunosuppression.
Analysis population: Participants who received Naive T cell depleted PBSCT and were alive at Day 100 post-transplant were analyzed.
Groups in this outcome
Arm A (MRD / High Intensity Conditioning)
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Arm B (MRD / Low Intensity Conditioning)
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
Arm C (MUD / High Intensity Conditioning)
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Arm D (MUD / Low Intensity Conditioning)
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
| Group | Source count |
|---|---|
| Arm A (MRD / High Intensity Conditioning) | 20 |
| Arm B (MRD / Low Intensity Conditioning) | 20 |
| Arm C (MUD / High Intensity Conditioning) | 17 |
| Arm D (MUD / Low Intensity Conditioning) | 18 |
Reported measurements
No chronic GVHD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (MRD / High Intensity Conditioning) | 17 | Not reported | Not reported | Not reported | Not reported |
| Arm B (MRD / Low Intensity Conditioning) | 20 | Not reported | Not reported | Not reported | Not reported |
| Arm C (MUD / High Intensity Conditioning) | 14 | Not reported | Not reported | Not reported | Not reported |
| Arm D (MUD / Low Intensity Conditioning) | 17 | Not reported | Not reported | Not reported | Not reported |
Mild Chronic GVHD not requiring systemic corticosteroids
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (MRD / High Intensity Conditioning) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm B (MRD / Low Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm C (MUD / High Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm D (MUD / Low Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
Mild Chronic GVHD requiring systemic corticosteroids
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (MRD / High Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (MRD / Low Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm C (MUD / High Intensity Conditioning) | 3 | Not reported | Not reported | Not reported | Not reported |
| Arm D (MUD / Low Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
Moderate Chronic GVHD (requiring systemic corticosteroids)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (MRD / High Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (MRD / Low Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm C (MUD / High Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm D (MUD / Low Intensity Conditioning) | 1 | Not reported | Not reported | Not reported | Not reported |
Severe Chronic GVHD (requiring systemic corticosteroids)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (MRD / High Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm B (MRD / Low Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm C (MUD / High Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
| Arm D (MUD / Low Intensity Conditioning) | 0 | Not reported | Not reported | Not reported | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- value
- 17
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 14
- group Id
- OG003
- value
- 17
- title
- No chronic GVHD
- categories
- measurements
- group Id
- OG000
- value
- 3
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Mild Chronic GVHD not requiring systemic corticosteroids
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 3
- group Id
- OG003
- value
- 0
- title
- Mild Chronic GVHD requiring systemic corticosteroids
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 1
- title
- Moderate Chronic GVHD (requiring systemic corticosteroids)
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Severe Chronic GVHD (requiring systemic corticosteroids)
- denoms
- counts
- group Id
- OG000
- value
- 20
- group Id
- OG001
- value
- 20
- group Id
- OG002
- value
- 17
- group Id
- OG003
- value
- 18
- units
- Participants
- description
- Occurrence of chronic graft-versus-host disease (GHVD), defined operationally as the occurrence of compatible symptoms meeting National Institutes of Health criteria and requiring systemic pharmacological immunosuppression.
- groups
- description
- HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- id
- OG000
- title
- Arm A (MRD / High Intensity Conditioning)
- description
- LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
- id
- OG001
- title
- Arm B (MRD / Low Intensity Conditioning)
- description
- HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
- id
- OG002
- title
- Arm C (MUD / High Intensity Conditioning)
- description
- LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
- id
- OG003
- title
- Arm D (MUD / Low Intensity Conditioning)
- param Type
- COUNT_OF_PARTICIPANTS
- population Description
- Participants who received Naive T cell depleted PBSCT and were alive at Day 100 post-transplant were analyzed.
- reporting Status
- POSTED
- time Frame
- Up to 5 years post-transplant
- title
- Chronic GVHD
- type
- PRIMARY
- unit Of Measure
- Participants
Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f
Preserved source evidence · Not medical advice