Trial Outcomes & Findings for Randomized Trial for Mixed Acute Rejection (NCT NCT00771875)
NCT ID: NCT00771875
Last Updated: 2016-01-27
Results Overview
Rejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment. Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
1 year
Results posted on
2016-01-27
Participant Flow
Participant milestones
| Measure |
Rabbit Antithymocyte Globulin (RATG)
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on cluster of differentiation 3 (CD3) count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via intravenous push (IVP) over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Overall Study
STARTED
|
10
|
10
|
10
|
|
Overall Study
COMPLETED
|
10
|
9
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial for Mixed Acute Rejection
Baseline characteristics by cohort
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 Participants
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 Participants
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 Participants
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
34.2 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
38.5 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
35.8 years
STANDARD_DEVIATION 10.8 • n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=5 Participants
|
9 participants
n=7 Participants
|
10 participants
n=5 Participants
|
29 participants
n=4 Participants
|
|
Type of Transplant
Deceased Donor Kidney Transplant
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
6 participants
n=4 Participants
|
|
Type of Transplant
Deceased Donor Simultaneous Pancreas/Kidney
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
4 participants
n=4 Participants
|
|
Type of Transplant
Living Donor
|
7 participants
n=5 Participants
|
7 participants
n=7 Participants
|
5 participants
n=5 Participants
|
19 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 1 yearRejection Reversal is a return of serum creatinine to within 115% of the baseline value, or histologic reversal occurring within 14 days of initiation of treatment. Recurrent Rejection is histologic evidence of rejection noted on a biopsy specimen obtained up to 3 months after documented rejection reversal.
Outcome measures
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 Participants
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 Participants
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 Participants
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection
Rejection Recurrence
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Patients in Each Group With Any of the Following: Rejection Reversal or Recurrent Rejection
Rejection Reversal
|
2 participants
|
1 participants
|
1 participants
|
SECONDARY outcome
Timeframe: Day 1Outcome measures
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 Participants
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 Participants
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 Participants
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Number of Patients With Allografts With C4d Focal Positive Pretreatment Biopsy
|
2 participants
|
2 participants
|
4 participants
|
SECONDARY outcome
Timeframe: 1 year after rejection treatmentOutcome measures
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 Participants
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 Participants
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 Participants
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Renal Allograft Survival
|
7 participants
|
7 participants
|
10 participants
|
SECONDARY outcome
Timeframe: 7, 14, 28, 60, 90 days and 1 year post therapy initiationRenal allograft function as determined by change (∆) in Calculated creatinine clearance by Cockcroft-Gault at 7, 14, 28, 60, and 90 days and 1 year post therapy initiation
Outcome measures
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 Participants
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 Participants
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 Participants
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Mean Serum Creatinine
28 days
|
2.9 mg/dL
Standard Deviation 1.23
|
2.35 mg/dL
Standard Deviation 0.90
|
2.18 mg/dL
Standard Deviation 0.47
|
|
Mean Serum Creatinine
60 days
|
2.62 mg/dL
Standard Deviation 1.23
|
2.32 mg/dL
Standard Deviation 0.87
|
2.38 mg/dL
Standard Deviation 0.62
|
|
Mean Serum Creatinine
7 days
|
3.04 mg/dL
Standard Deviation 1.67
|
2.32 mg/dL
Standard Deviation 0.89
|
2.31 mg/dL
Standard Deviation 0.78
|
|
Mean Serum Creatinine
14 days
|
3.25 mg/dL
Standard Deviation 1.76
|
2.35 mg/dL
Standard Deviation 0.95
|
2.20 mg/dL
Standard Deviation 0.69
|
|
Mean Serum Creatinine
90 days
|
2.48 mg/dL
Standard Deviation 1.18
|
2.12 mg/dL
Standard Deviation 1.01
|
2.13 mg/dL
Standard Deviation 0.54
|
|
Mean Serum Creatinine
1 year
|
2.19 mg/dL
Standard Deviation 0.84
|
2.07 mg/dL
Standard Deviation 1.10
|
2.87 mg/dL
Standard Deviation 1.37
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 Participants
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 Participants
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 Participants
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Incidence of Death
|
0 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 90 daysOutcome measures
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 Participants
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 Participants
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 Participants
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Number of Patients With Allografts With C4d Diffuse Positive Pretreatment Biopsy
|
3 participants
|
3 participants
|
5 participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 Participants
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 Participants
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 Participants
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Incidence of Post Transplant Lymphoproliferative Disorder (PTLD)
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Rabbit Antithymocyte Globulin (RATG)
Serious events: 7 serious events
Other events: 10 other events
Deaths: 0 deaths
RATG/Rituximab
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
RATG/Bortezomib
Serious events: 7 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 participants at risk
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 participants at risk
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 participants at risk
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Death due to hypoglycemic attack and respiratory distress
|
0.00%
0/10 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
General disorders
Pain and Tenderness at Pheresis Line
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Infections and infestations
Infection
|
40.0%
4/10 • Number of events 4 • 1 year
|
44.4%
4/9 • Number of events 4 • 1 year
|
50.0%
5/10 • Number of events 5 • 1 year
|
|
Cardiac disorders
Coronary Artery Disease
|
20.0%
2/10 • Number of events 2 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/10 • 1 year
|
|
Surgical and medical procedures
Surgical Complication
|
40.0%
4/10 • Number of events 4 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
Gastrointestinal disorders
Gastrointestinal Disorder
|
30.0%
3/10 • Number of events 3 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Renal Dysfunction
|
70.0%
7/10 • Number of events 19 • 1 year
|
55.6%
5/9 • Number of events 10 • 1 year
|
70.0%
7/10 • Number of events 20 • 1 year
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/10 • 1 year
|
|
Blood and lymphatic system disorders
Serum Sickness
|
10.0%
1/10 • Number of events 1 • 1 year
|
0.00%
0/9 • 1 year
|
0.00%
0/10 • 1 year
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
0.00%
0/10 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/10 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
0.00%
0/10 • 1 year
|
|
Vascular disorders
Thombosis
|
0.00%
0/10 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Dehydration
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Gastrointestinal disorders
Hemorrhage of Lower GI
|
0.00%
0/10 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
Other adverse events
| Measure |
Rabbit Antithymocyte Globulin (RATG)
n=10 participants at risk
RATG
Rabbit Antithymocyte Globulin (RATG): All patients will receive Thymoglobulin dosed based on CD3 count. Patients will be redosed when the CD3 count is ≥ 25. Depending on rejection severity, Thymoglobulin will be given for a maximum of 7-14 days. CD3 levels will be monitored daily.
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
RATG/Rituximab
n=9 participants at risk
Rabbit Antithymocyte Globulin (RATG) + Rituximab
Rituximab: Rituximab dose of 375 mg/ m2 on day 2. Patients will be premedicated with an antihistamine and acetaminophen prior to dosing per institution standard of care.
|
RATG/Bortezomib
n=10 participants at risk
Rabbit Antithymocyte Globulin (RATG) + Bortezomib
Bortezomib: Patient will receive 1.3 mg/m2 via IV push over 3-5 seconds on days 2, 5, 9, and 12. Consolidation course of bortezomib will be dosed at 1.3 mg/m2 IVP X 4 doses administered on days 1, 4, 7 and 10.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Grade 4 Thrombocytopenia
|
0.00%
0/10 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
0.00%
0/10 • 1 year
|
|
Gastrointestinal disorders
Grade 1 Nausea/Vomiting
|
60.0%
6/10 • Number of events 6 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
50.0%
5/10 • Number of events 5 • 1 year
|
|
Gastrointestinal disorders
Grade 2 Nausea/Vomiting
|
10.0%
1/10 • Number of events 1 • 1 year
|
55.6%
5/9 • Number of events 5 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Gastrointestinal disorders
Grade 1 Diarrhea
|
60.0%
6/10 • Number of events 6 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Renal and urinary disorders
Worsened Peripheral Neuropathy
|
10.0%
1/10 • Number of events 1 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Grade 2 Anemia
|
50.0%
5/10 • Number of events 5 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
30.0%
3/10 • Number of events 3 • 1 year
|
|
Blood and lymphatic system disorders
Grade 3 Anemia
|
50.0%
5/10 • Number of events 5 • 1 year
|
44.4%
4/9 • Number of events 5 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Blood and lymphatic system disorders
Grade 4 Anemia
|
10.0%
1/10 • Number of events 1 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
0.00%
0/10 • 1 year
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/10 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
Infections and infestations
Cytomegalovirus (CMV) infection
|
0.00%
0/10 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
Infections and infestations
BK Virus
|
0.00%
0/10 • 1 year
|
11.1%
1/9 • Number of events 1 • 1 year
|
0.00%
0/10 • 1 year
|
|
General disorders
Productive Cough
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Skin and subcutaneous tissue disorders
Tingling
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Level 1 Peripheral Neuropathy
|
50.0%
5/10 • Number of events 5 • 1 year
|
33.3%
3/9 • Number of events 4 • 1 year
|
40.0%
4/10 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Level 2 Peripheral Neuropathy
|
0.00%
0/10 • 1 year
|
33.3%
3/9 • Number of events 3 • 1 year
|
40.0%
4/10 • Number of events 4 • 1 year
|
|
Renal and urinary disorders
Level 3 Peripheral Neuropathy
|
0.00%
0/10 • 1 year
|
22.2%
2/9 • Number of events 2 • 1 year
|
20.0%
2/10 • Number of events 2 • 1 year
|
|
Renal and urinary disorders
Grade 2 Peripheral Neuropathy
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Level 4 Peripheral Neuropathy
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
|
Renal and urinary disorders
Level 5 Peripheral Neuropathy
|
0.00%
0/10 • 1 year
|
0.00%
0/9 • 1 year
|
10.0%
1/10 • Number of events 1 • 1 year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place