Trial Outcomes & Findings for Sirolimus, Mycophenolate Mofetil and Bortezomib as Graft-Versus-Host Disease (GVHD) Prophylaxis After Reduced Intensity Conditioning (RIC) Hematopoietic Stem Cell Transplantation (NCT NCT00548717)
NCT ID: NCT00548717
Last Updated: 2014-10-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
15 participants
Primary outcome timeframe
150 days
Results posted on
2014-10-21
Participant Flow
Participants were recruited at Dana Farber Cancer Institute. The first participant was enrolled in November 2007. Enrollment was halted May 2008 due to an unacceptable rate of acute GVHD. The study reopened in November 2012 with addition of bortezomib. The last participant enrolled May 2013. The study was permanently closed to accural August 2013.
Participant milestones
| Measure |
Siro/MMF
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis
Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF)
|
Siro/MMF/Bort
Sirolimus, Mycophenolate Mofetil, and Bortezomib for GVHD prophylaxis
Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF) Bortezomib (Velcade)
\*Bortezomib added when study reopened in November 2012
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
2
|
|
Overall Study
COMPLETED
|
4
|
0
|
|
Overall Study
NOT COMPLETED
|
9
|
2
|
Reasons for withdrawal
| Measure |
Siro/MMF
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis
Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF)
|
Siro/MMF/Bort
Sirolimus, Mycophenolate Mofetil, and Bortezomib for GVHD prophylaxis
Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF) Bortezomib (Velcade)
\*Bortezomib added when study reopened in November 2012
|
|---|---|---|
|
Overall Study
Death
|
5
|
2
|
|
Overall Study
Relapse
|
3
|
0
|
|
Overall Study
Alternative treatment for GVHD
|
1
|
0
|
Baseline Characteristics
Sirolimus, Mycophenolate Mofetil and Bortezomib as Graft-Versus-Host Disease (GVHD) Prophylaxis After Reduced Intensity Conditioning (RIC) Hematopoietic Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Siro/MMF
n=13 Participants
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
|
Siro/MMF/Bort
n=2 Participants
Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) \*added with study reopening in 2012
|
Total
n=15 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
2 participants
n=7 Participants
|
15 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 150 daysOutcome measures
| Measure |
Siro/MMF
n=13 Participants
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
|
Siro/MMF/Bort
n=2 Participants
Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|---|
|
To Determine the Rate of Grade II-IV Acute GVHD When Sirolimus and Mycophenolate Mofetil or Sirolimus, Mycophenolate Mofetil and Bortezomib is Used for GVHD Prophylaxis After Allogeneic Stem Cell Transplantation in Patients With Hematologic Malignancies
|
77 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 30 daysEngraftment of donor cells by week 4 after transplantation. Assessment of donor stem cell engraftment will include donor-host hematopoietic chimerism analyses at 4 weeks and every 3 months after transplantation. Chimerism measured from peripheral blood or from bone marrow.
Outcome measures
| Measure |
Siro/MMF
n=13 Participants
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
|
Siro/MMF/Bort
n=2 Participants
Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|---|
|
Donor Stem Cell Engraftment, Including Donor-host Hematopoietic Chimerism Studies Post Transplant
|
9 participants
|
2 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: One patient experienced grade 5 renal toxicity
Renal function will be measured weekly after transplant for 4 weeks, at 8 weeks and then at 3 month intervals from transplantation. Sentinel renal events such as the occurrence of thrombotic microangiopathy will be noted. The rationale for the substitution of mycophenolate mofetil for tacrolimus is to continue to prevent acute GVHD, but minimize renal toxicity after transplantation. We will thus monitor renal toxicity closely in this study. In our previous experience, the rate of grade III-V renal toxicity by day 100 after transplantation was about 10%. Here, grade III is defined as a creatinine level between 3.1 to 6 times the normal level, grade IV is defined as a creatinine level 6 times or more the normal level, and grade V is defined as a fatality due to renal toxicity.
Outcome measures
| Measure |
Siro/MMF
n=13 Participants
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
|
Siro/MMF/Bort
n=2 Participants
Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|---|
|
The Rate of Renal Insufficiency
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: In the Siro/MMF group, the overall number of participants analyzed was 13, however, the number of participants with the MMF level data available varies at each time point. For the Siro/MMF/Bort group, no data were analyzed due to no data available for this Outcome Measure.
This outcome measure was presented as a comparison between incidence of Grade 0-I aGVHD and Grade II-IV aGVHD across 5 time points (Weeks 1,2,3,8, and 12).
Outcome measures
| Measure |
Siro/MMF
n=13 Participants
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
|
Siro/MMF/Bort
Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|---|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 1 MMF level (0-I aGVHD), n=3
|
2.43 ng/mL
Standard Deviation 1.19
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 1 MMF level (II-IV aGVHD), n=8
|
2.70 ng/mL
Standard Deviation 1.25
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 2 MMF level (0-I aGVHD), n=3
|
3.40 ng/mL
Standard Deviation 1.37
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 2 MMF level (II-IV aGVHD), n=6
|
3.07 ng/mL
Standard Deviation 2.25
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 3 MMF level (0-I aGVHD), n=3
|
2.57 ng/mL
Standard Deviation 1.35
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 3 MMF level (II-IV aGVHD), n=6
|
2.85 ng/mL
Standard Deviation 2.09
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 8 MMF level (0-I aGVHD), n=3
|
2.37 ng/mL
Standard Deviation 0.75
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 8 MMF level (II-IV aGVHD), n=4
|
2.13 ng/mL
Standard Deviation 1.18
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 12 MMF level (0-I aGVHD), n=2
|
1.75 ng/mL
Standard Deviation 0.07
|
—
|
|
To Correlate the Serum Concentrations of Mycophenolate Mofetil and Its Metabolites With Acute GVHD Incidence
Week 12 MMF level (II-IV aGVHD), n=4
|
2.20 ng/mL
Standard Deviation 1.19
|
—
|
SECONDARY outcome
Timeframe: 100 daysOutcome measures
| Measure |
Siro/MMF
n=13 Participants
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
|
Siro/MMF/Bort
n=2 Participants
Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|---|
|
Incidence of 100 Day Mortality
|
31 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearChronic GVHD will be graded according to the modified Seattle criteria. Chronic GVHD divided into limited and extensive and evaluated across the following systems: skin, cutaneous structures, liver, mouth, eyes, esophagus, intestines, lung, musculoskeletal, serous, nervous, urologic, vagina, hematopoietic, and immune. Localized skin involvement with or without hepatic dysfunction is classified as limited disease. Generalized skin involvement or limited disease plus eye involvement, oral involvement, hepatic dysfunction with abnormal liver histology, or involvement of any other target organ was classified as extensive disease. Lee SJ, Vogelsang G, Flowers ME. Chronic graft-versus-host disease. Biol Blood Marrow Transplant. 2003;9:215-33.
Outcome measures
| Measure |
Siro/MMF
n=13 Participants
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
|
Siro/MMF/Bort
n=2 Participants
Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|---|
|
Incidence of Chronic GVHD
|
15 percentage of participants
|
50 percentage of participants
|
SECONDARY outcome
Timeframe: 1 yearOutcome measures
| Measure |
Siro/MMF
n=13 Participants
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
|
Siro/MMF/Bort
n=2 Participants
Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|---|
|
Overall Survival
|
39 percentage of participants
|
0 percentage of participants
|
Adverse Events
Siro/MMF (+/- Bortezomib)
Serious events: 8 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Siro/MMF (+/- Bortezomib)
n=15 participants at risk
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis (+/- Bortezomib)
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|
|
General disorders
Fever
|
6.7%
1/15 • Number of events 1 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
General disorders
Multi-organ Failure
|
6.7%
1/15 • Number of events 1 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Immune system disorders
GVHD
|
13.3%
2/15 • Number of events 2 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Infections and infestations
HHV6 encephalitis
|
6.7%
1/15 • Number of events 1 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Eye disorders
Temporary blindness
|
6.7%
1/15 • Number of events 1 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Infections and infestations
Sepsis
|
20.0%
3/15 • Number of events 3 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Infections and infestations
Pneumonia
|
6.7%
1/15 • Number of events 1 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
Other adverse events
| Measure |
Siro/MMF (+/- Bortezomib)
n=15 participants at risk
Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis (+/- Bortezomib)
Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) \*added with study reopening in 2012
|
|---|---|
|
Infections and infestations
Documented infection
|
46.7%
7/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Infections and infestations
Suspected Undocumented infection
|
26.7%
4/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Hepatobiliary disorders
Cholecystitis
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Gastrointestinal disorders
Dehydration
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Gastrointestinal disorders
Diarrhea
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Nervous system disorders
Encephalopathy
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Gastrointestinal disorders
Necrosis-small bowel NOS
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Renal and urinary disorders
Renal Toxicity
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
|
Nervous system disorders
Neurologic Toxicity
|
6.7%
1/15 • Participating investigators will assess the occurrence of AEs and SAEs at all participant evaluation time points during the study. All SAEs and grade 3 or higher treatment and/or transplant related toxicities (AEs) are recorded.
It is not simple to segregate prophylactic regimen related from transplant related toxicities. We thus report transplant and/or regimen related toxicities combined and do not segregate toxicities by regimen. Moreover, since only 2 patients received Siro/MMF/Bort, comparison of toxicites between the two regimens is infeasible.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place