Trial Outcomes & Findings for Phase II Trial of Pentostatin and Targeted Busulfan (NCT NCT00496340)
NCT ID: NCT00496340
Last Updated: 2014-06-05
Results Overview
The primary endpoint was achievement of \>/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
42 participants
Primary outcome timeframe
28 days post-transplant
Results posted on
2014-06-05
Participant Flow
Participants were enrolled at H. Lee Moffitt Cancer Center between February 2008 and March 2011.
Participant milestones
| Measure |
Conditioning Followed by HCT
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total area under curve (AUC) of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Overall Study
STARTED
|
42
|
|
Overall Study
COMPLETED
|
42
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Trial of Pentostatin and Targeted Busulfan
Baseline characteristics by cohort
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Age, Continuous
|
53 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
38 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
31 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days post-transplantPopulation: All participants
The primary endpoint was achievement of \>/= 50% donor chimerism in CD3+ peripheral blood lymphocytes by day +28 (± 7) after allogeneic hematopoietic cell transplantation (allo-HCT).
Outcome measures
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Incidence of Greater Than or Equal to 50% Donor Chimerism
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 28 days post-transplantPopulation: All participants
Hematologic engraftment: defined as time to achieve an absolute neutrophil count (ANC) \>/= 500/µl for 3 consecutive days or a platelet count of \>/= 20,000//µl without the need for platelet support.
Outcome measures
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Cumulative Incidence of Hematopoietic Cell Engraftment
|
97.6 percentage of participants
Interval 90.6 to 100.0
|
SECONDARY outcome
Timeframe: 28 days post-transplantPopulation: Participants with bone marrow chimerism data available at time of analysis.
Median Percentage of Donor Cells in Study Population (Chimerism).
Outcome measures
| Measure |
Conditioning Followed by HCT
n=38 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28
CD3+
|
87 percentage of cells
Interval 61.0 to 100.0
|
|
Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +28
CD33+
|
100 percentage of cells
Interval 95.0 to 100.0
|
SECONDARY outcome
Timeframe: 100 days post-transplantPopulation: Participants with bone marrow chimerism data available at time of analysis.
Median Percentage of Donor Cells in Study Population (Chimerism).
Outcome measures
| Measure |
Conditioning Followed by HCT
n=36 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100
CD3+
|
96 percentage of cells
Interval 64.0 to 100.0
|
|
Rate of T-cell (CD3+) and Myeloid (CD33+) Chimerism by Day +100
CD33+
|
100 percentage of cells
Interval 100.0 to 100.0
|
SECONDARY outcome
Timeframe: Up to 2 years post-transplantPopulation: All participants
The cumulative incidence of NRM after allo-HCT.
Outcome measures
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Non-relapse Mortality Rate (NRM)
Day +100
|
2 percentage of participants
Interval 0.0 to 9.0
|
|
Non-relapse Mortality Rate (NRM)
2 Years
|
17 percentage of participants
Interval 7.0 to 30.0
|
SECONDARY outcome
Timeframe: Up to 2 years post-transplantPopulation: All participants
Infections: Incidence of infections (opportunistic and non-opportunistic) following conditioning.
Outcome measures
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Incidence of Infections
Cytomegalovirus (CMV) Reactivation
|
17 participants
|
|
Incidence of Infections
Epstein-Barr virus (EBV) Reactivation
|
3 participants
|
|
Incidence of Infections
Post-transplantation Lymphoproliferative Disorder
|
1 participants
|
|
Incidence of Infections
Viral Infections
|
5 participants
|
|
Incidence of Infections
Lung Infections
|
2 participants
|
SECONDARY outcome
Timeframe: Up to 2 years post-transplantPopulation: All participants
The median time from allo-HCT to the initiation of tacrolimus (TAC) taper. The median time to onset of acute GVHD (aGVHD). Clinical manifestations of acute GVHD include a classic maculopapular rash; persistent nausea and/or emesis; abdominal cramps with diarrhea; and a rising serum bilirubin concentration.
Outcome measures
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Time to Incidence of Graft Versus Host Disease (GVHD)
Initiation of TAC Taper
|
62 days
Interval 38.0 to 377.0
|
|
Time to Incidence of Graft Versus Host Disease (GVHD)
Onset of aGVHD
|
33 days
Interval 14.0 to 85.0
|
SECONDARY outcome
Timeframe: Up to 2 years post-transplantPopulation: All participants
By day +100, the cumulative incidence of GVHD, acute of grades 2-4, and 3-4. At 2 years, the cumulative incidence of chronic GVHD of any severity according to National Institutes of Health (NIH) consensus criteria. Diagnosis of chronic GVHD requires the presence of at least one diagnostic clinical sign of chronic GVHD or the presence of at least one distinctive manifestation confirmed by pertinent biopsy or other relevant tests in the same or another organ. Furthermore, other possible diagnoses for clinical symptoms must be excluded. No time limit is set for the diagnosis of chronic GVHD. At 2 years, the cumulative incidence of moderate/severe chronic GVHD.
Outcome measures
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Incidence of Graft Versus Host Disease (GVHD)
Day +100 aGVHD Grade 2-4
|
59 percentage of participants
Interval 43.0 to 75.0
|
|
Incidence of Graft Versus Host Disease (GVHD)
Day +100 aGVHD Grade 3-4
|
19 percentage of participants
Interval 7.0 to 35.0
|
|
Incidence of Graft Versus Host Disease (GVHD)
2 Years, Chronic GVHD of Any Severity
|
69 percentage of participants
Interval 53.0 to 83.0
|
|
Incidence of Graft Versus Host Disease (GVHD)
2 Years, Moderate/Severe Chronic GVHD
|
58 percentage of participants
Interval 39.0 to 75.0
|
SECONDARY outcome
Timeframe: 2 years post-transplantPopulation: All participants
PFS at 2 years post-transplant. PFS, defined as time from day of hematopoietic cell infusion to disease relapse. Relapsed disease: Disease was in complete remission post-transplant but returned (e.g., \>5% blast in bone marrow or any peripheral blasts).
Outcome measures
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Percentage of Participants With Progression Free Survival (PFS)
|
55 percentage of participants
Interval 39.0 to 69.0
|
SECONDARY outcome
Timeframe: 2 years post-transplantPopulation: All participants
OS at 2 years post-transplant. OS, defined as time from day of hematopoietic cell infusion to death from any cause.
Outcome measures
| Measure |
Conditioning Followed by HCT
n=42 Participants
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Percentage of Participants With Overall Survival (OS)
|
68 percentage of participants
Interval 53.0 to 81.0
|
Adverse Events
Conditioning Followed by HCT
Serious events: 25 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Conditioning Followed by HCT
n=42 participants at risk
Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)
Pre-conditioning therapy:
All participants receive pentostatin 4 mg/m\^2 on day -28, may receive additional doses on days -21 \& -14 depending on cell counts.
Conditioning:
1. Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6
2. Intravenous Busulfan (1st dose) at a dose of 200mg/m\^2 on day -4
3. Pentostatin, 4 mg/m\^2 by intravenous infusion over 1-2 hours on days -4, -3
4. Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600
5. Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan
6. Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m\^2 according to prescribing and institutional guidelines
|
|---|---|
|
Blood and lymphatic system disorders
Blood/Bone Marrow - Other, Complications with GVHD
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Cardiac disorders
Cardiac General - Other, Cardiac arrest
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Blood and lymphatic system disorders
Coagulation - Other, Right jugular vein occlusion
|
4.8%
2/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
4.8%
2/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
General disorders
Fever (in the absence of neutropenia)
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
General disorders
Death not associated with CTCAE term - Death NOS
|
11.9%
5/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin - Other, Shingles reactivation
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Endocrine disorders
Pancreatic endocrine: glucose intolerance
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Gastrointestinal disorders
Diarrhea
|
7.1%
3/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Gastrointestinal disorders
Enteritis (inflammation of the small bowel)
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Gastrointestinal disorders
Typhlitis (cecal inflammation)
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Gastrointestinal disorders
Vomiting
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Vascular disorders
Hematoma
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Bronchopulmonary NOS
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory - Nose
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Hepatobiliary disorders
Liver dysfunction/failure (clinical)
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Blood
|
4.8%
2/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Eye NOS
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Lung
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Skin
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection (documented clinically or microbiologically) with Grade 3 or 4 neutrophils - Upper airway
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung
|
4.8%
2/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils - Stomach
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Metabolism and nutrition disorders
Creatinine - high
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Musculoskeletal and connective tissue disorders
Cervical spine-range of motion
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Musculoskeletal and connective tissue disorders
Joint-effusion
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Psychiatric disorders
Confusion
|
4.8%
2/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Psychiatric disorders
Mental status
|
4.8%
2/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Nervous system disorders
Seizure
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Eye disorders
Vision-photophobia
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Nervous system disorders
Pain - Head/headache
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
General disorders
Pain - Other, chest/epigastric
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory - Other, Respiratory failure
|
4.8%
2/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Renal and urinary disorders
Obstruction, GU - Bladder
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Renal and urinary disorders
Renal failure
|
7.1%
3/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - Basal cell
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy - EBV driven PTLD
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
|
Vascular disorders
Thrombosis/thrombus/embolism
|
2.4%
1/42 • Up to 2 years post-transplant
There were no Adverse Events (AEs) that would not be expected for transplant patients.
|
Other adverse events
Adverse event data not reported
Additional Information
Marcie Riches, MD
H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-6284
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place