TriangleNCT00520130 · OUTCOME
Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
- Measure
- MEDIAN
- Unit
- Divergence index
- Interval / dispersion
- Full Range
- Time frame
- Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant
What was measured
Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.
Analysis population: The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.
Groups in this outcome
A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm
Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
B - Cyclosporine (AC) Arm
Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
| Group | Source count |
|---|---|
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 8 |
| B - Cyclosporine (AC) Arm | 9 |
Reported measurements
1 month
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 48 | Not reported | 26 | 69 | Not reported |
| B - Cyclosporine (AC) Arm | 90 | Not reported | 63 | 111 | Not reported |
3 months
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 31 | Not reported | 23 | 60 | Not reported |
| B - Cyclosporine (AC) Arm | 66 | Not reported | 47 | 93 | Not reported |
6 mo (TMS=7; AC= 9)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 35 | Not reported | 21 | 57 | Not reported |
| B - Cyclosporine (AC) Arm | 75 | Not reported | 32 | 93 | Not reported |
12 mo (TMS=7; AC=9)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 30 | Not reported | 23 | 81 | Not reported |
| B - Cyclosporine (AC) Arm | 67 | Not reported | 25 | 92 | Not reported |
Donor CD4 cells (TMS=8; AC=8)
| Group | Value | Spread | Lower | Upper | Comment |
|---|---|---|---|---|---|
| A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm | 23 | Not reported | 17 | 29 | Not reported |
| B - Cyclosporine (AC) Arm | 22 | Not reported | 18 | 35 | Not reported |
Complete source fields
- classes
- categories
- measurements
- group Id
- OG000
- lower Limit
- 26
- upper Limit
- 69
- value
- 48
- group Id
- OG001
- lower Limit
- 63
- upper Limit
- 111
- value
- 90
- title
- 1 month
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23
- upper Limit
- 60
- value
- 31
- group Id
- OG001
- lower Limit
- 47
- upper Limit
- 93
- value
- 66
- title
- 3 months
- categories
- measurements
- group Id
- OG000
- lower Limit
- 21
- upper Limit
- 57
- value
- 35
- group Id
- OG001
- lower Limit
- 32
- upper Limit
- 93
- value
- 75
- title
- 6 mo (TMS=7; AC= 9)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 23
- upper Limit
- 81
- value
- 30
- group Id
- OG001
- lower Limit
- 25
- upper Limit
- 92
- value
- 67
- title
- 12 mo (TMS=7; AC=9)
- categories
- measurements
- group Id
- OG000
- lower Limit
- 17
- upper Limit
- 29
- value
- 23
- group Id
- OG001
- lower Limit
- 18
- upper Limit
- 35
- value
- 22
- title
- Donor CD4 cells (TMS=8; AC=8)
- denoms
- counts
- group Id
- OG000
- value
- 8
- group Id
- OG001
- value
- 9
- units
- Participants
- description
- Ribonucleic acid (RNA) was extracted from sorted CD4 and cluster of differentiation 8 (CD8) T cells and analyzed for Vbeta repertoire by nested polymerase chain reaction (PCR) analysis using Vbeta family specific primers and a labeled constant region primer (spectratyping). The receptor repertoire diversity was calculated from spectratyping data by creating a normal standard for repertoire diversity from healthy normal controls and assessing the divergence of individual patient's T cell receptor repertoire from these standard normal donor values. In this Vbeta repertoire divergence index, lower numbers are consistent with a more normal highly diverse repertoire, and high numbers represent a highly skewed, oligoclonal repertoire. The assay is described in Memon SA et al, J Immunol Methods, 2012, 375: 84-92. The repertoire diversity of the CD4 and CD8 T cells of the donor infusion is shown for comparison.
- dispersion Type
- Full Range
- groups
- description
- Rituximab: 375 mg/m2 intravenous (IV), day 1 for patients (pts) with cluster of differentiation 20-positive disease. Allogenic stem cell transplant (txplt). Fludarabine:30 mg/m2 per day IV over 30 min. daily. On days -6, -5, -4, and -3. Cyclophosphamide:1200 mg/m2 per day IV over 2 hrs on Days 6, -5, -4, -3. Mesna:1200 mg/m2 per day IV, Daily on days 6, -5,-4, and -3.Tacrolimus: day -3 before txplt, 0.02 mg/kg/day CIV, then switch to an equivalent oral dose (when pts taking po) titrated for a goal level of 5-10 ng/ml; Sirolimus: loading dose of 12 mg p.o. on day -3 pre-txplt, 4 mg day -2 pre-txplt and titrated for levels 3-12 ng/ml; Methotrexate 5 mg/m2 IV on days +1, +3, +6, and +11 post txplt). Tacrolimus and sirolimus will be tapered at day +63, day +119 and day +180 post-txplt as tolerated. Fludarabine:25 mg/m2 per day IV over 30 minutes, Daily on days 1-5.Cytarabine: 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim: 5 mcg/kg per day SC beginning 24 hrs before chemo.
- id
- OG000
- title
- A - Tacrolimus, Methotrexate, Sirolimus (TMS) Arm
- description
- Rituximab375 mg/m2 IV, day 1 for pts with CD20-positive disease. Cyclosporine IV over 2 hrs or orally every 12 hrs on days -1-100, followed by a taper if GVHD does not develop. Allogenic stem cell transplant. Conditioning Chemotherapy Fludarabine:30 mg/m2 per day IV infusion over 30 min., daily on days -6, -5, -4, and -3. Cyclophosphamide1200 mg/m2 per day IV infusion over 2 hrs on Days 6, -5, -4, -3. Mesna1200 mg/m2 per day IV infusion, Daily on days 6, -5,-4, and -3. FLAG: Fludarabine25 mg/m2 per day IV over 30 min., Daily on days 1-5. Cytarabine 2,000 mg/m2 IV over 4 hrs, on Days 1, 2, 3, 4, 5. Filgrastim 5 mcg/kg per day SC beginning 24 hrs PRIOR to start of chemotherapy. EPOCH-F: Fludarabine25 mg/m2 per day IV infusion over 30 min., daily on days 1-4. Etoposide 50 mg/m2 per day continuous IV infusion over 24 hrs on days 1-4. Doxorubicin10 mg/m2/d. Grp 2 Alemtuzumab for 4 days starting 8 days before SCT + cyclosporine starting 1 day before SCT and continuing for 6 months.
- id
- OG001
- title
- B - Cyclosporine (AC) Arm
- param Type
- MEDIAN
- population Description
- The original intention was to perform these assays on the first 10 pts within each arm. One pt died within the first mo., others died within the 1st yr. Not all donors gave consent for research analyses to be done on their cells, hence cells from those donors were not available.
- reporting Status
- POSTED
- time Frame
- Donor at time of collection and recipient at 1, 3, 6 and 12 months post transplant
- title
- Changes in Cluster of Differentiation 4 (CD4) T Cell Receptor Vbeta Repertoire
- type
- PRIMARY
- unit Of Measure
- Divergence index
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Preserved source evidence · Not medical advice