TriangleNCT02220985 · OUTCOME
Acute 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
- Through day 100 post-transplant
What was measured
Presence of acute graft-versus-host disease (GVHD) grades II-IV, defined operationally as the occurrence of compatible symptoms or signs in the skin, gastrointestinal tract, or liver, in patients who received Naive t cell depleted PBSCT. Staging and grading are found on page 8 of the JCO supplement (Bleakley et al., 2022, original references Glucksberg et all, 1974, Przepiorka et all, 1995 ) with higher grade indicating worse outcomes.
Analysis population: Participants who received Naive T Cell Depleted PBSC and were alive at day 100 post-transplant
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 acute GVHD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (MRD / High Intensity Conditioning) | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm B (MRD / Low Intensity Conditioning) | 5 | Not reported | Not reported | Not reported | Not reported |
| Arm C (MUD / High Intensity Conditioning) | 4 | Not reported | Not reported | Not reported | Not reported |
| Arm D (MUD / Low Intensity Conditioning) | 3 | Not reported | Not reported | Not reported | Not reported |
Grade II acute GVHD
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| Arm A (MRD / High Intensity Conditioning) | 15 | Not reported | Not reported | Not reported | Not reported |
| Arm B (MRD / Low Intensity Conditioning) | 14 | Not reported | Not reported | Not reported | Not reported |
| Arm C (MUD / High Intensity Conditioning) | 13 | Not reported | Not reported | Not reported | Not reported |
| Arm D (MUD / Low Intensity Conditioning) | 15 | Not reported | Not reported | Not reported | Not reported |
Grade III acute GVHD
| 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) | 1 | 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 |
Grade IV acute GVHD
| 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
- 5
- group Id
- OG001
- value
- 5
- group Id
- OG002
- value
- 4
- group Id
- OG003
- value
- 3
- title
- No acute GVHD
- categories
- measurements
- group Id
- OG000
- value
- 15
- group Id
- OG001
- value
- 14
- group Id
- OG002
- value
- 13
- group Id
- OG003
- value
- 15
- title
- Grade II acute GVHD
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 1
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Grade III acute GVHD
- categories
- measurements
- group Id
- OG000
- value
- 0
- group Id
- OG001
- value
- 0
- group Id
- OG002
- value
- 0
- group Id
- OG003
- value
- 0
- title
- Grade IV acute GVHD
- 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
- Presence of acute graft-versus-host disease (GVHD) grades II-IV, defined operationally as the occurrence of compatible symptoms or signs in the skin, gastrointestinal tract, or liver, in patients who received Naive t cell depleted PBSCT. Staging and grading are found on page 8 of the JCO supplement (Bleakley et al., 2022, original references Glucksberg et all, 1974, Przepiorka et all, 1995 ) with higher grade indicating worse outcomes.
- 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 PBSC and were alive at day 100 post-transplant
- reporting Status
- POSTED
- time Frame
- Through day 100 post-transplant
- title
- Acute GVHD
- type
- PRIMARY
- unit Of Measure
- Participants
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Preserved source evidence · Not medical advice