Trial Outcomes & Findings for Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation (NCT NCT00698685)
NCT ID: NCT00698685
Last Updated: 2017-03-31
Results Overview
The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
14 participants
Primary outcome timeframe
Day 100 after transplant.
Results posted on
2017-03-31
Participant Flow
Following University of Arizona IRB review and approval, the study opened to accrual on November 2005 at the Arizona Cancer Center clinic and University Medical Center sites \[Tucson, Arizona\].
Following consent process, subjects who consented to participate were screened per the selection criteria in the study.
Participant milestones
| Measure |
Preparative Regimen of Pentostatin and Alemtuzumab
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
|
|---|---|
|
Overall Study
STARTED
|
14
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Preparative Regimen of Pentostatin and Alemtuzumab
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
|
|---|---|
|
Overall Study
Sister withdrew as donor
|
1
|
|
Overall Study
Off study pre transplant by clinic MD
|
1
|
Baseline Characteristics
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic Peripheral Blood Stem Cell Transplantation
Baseline characteristics by cohort
| Measure |
Preparative Regimen of Pentostatin and Alemtuzumab
n=14 Participants
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
3 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
|
Region of Enrollment
United States
|
14 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Day 100 after transplant.Population: All participants who completed treatment and underwent allogeneic transplant.
The number of participants with donor hematopoietic engraftment at day 100 is reported in the data table, and the actuarial probability is calculated using the Kaplan-Meier product-limit estimate statistic, as reported in the statistical analysis section below.
Outcome measures
| Measure |
Preparative Regimen of Pentostatin and Alemtuzumab
n=12 Participants
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
|
|---|---|
|
Actuarial Probability of Donor Hematopoietic Engraftment (Defined as at Least 50% Donor DNA in Bone Marrow at Day 100).
|
4 participants
|
PRIMARY outcome
Timeframe: Day 100 after transplantPopulation: All participants who received at least 1 day of treatment.
The primary safety outcome is indicated by the number of participants who died at or before Day 100 after transplant for any reason other than relapse of disease (Leukemia, Lymphoma, Hodgkin's disease, Hematologic Neoplasms, Multiple Myeloma, Renal Cell Carcinoma).
Outcome measures
| Measure |
Preparative Regimen of Pentostatin and Alemtuzumab
n=13 Participants
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
|
|---|---|
|
Non-relapse Mortality at or Before Day 100
|
3 Participants
|
Adverse Events
Preparative Regimen of Pentostatin and Alemtuzumab
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Preparative Regimen of Pentostatin and Alemtuzumab
n=13 participants at risk
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
|
|---|---|
|
Blood and lymphatic system disorders
metabolic/laboratory: elevated AST and ALT
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Renal and urinary disorders
hemorrhagic cystitis associated with BK virus
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia and dyspnea which was a result of pulmonary hemorrhage
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Infections and infestations
altered mental status and progressive obtundation [disseminated toxoplasmosis]
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
hyperbilirubinemia
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Infections and infestations
disseminated toxoplasmosis
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Renal and urinary disorders
thrombotic microangiopathy
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Death on study, post BMT
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
Other adverse events
| Measure |
Preparative Regimen of Pentostatin and Alemtuzumab
n=13 participants at risk
Pentostatin and Alemtuzumab as a Preparative Regimen for Allogeneic \[related or unrelated\] Hematopoietic SCT.
Pentostatin: 4 mg/m2/24 hour IV continuously over 72 hours on days -8 to -6. Alemtuzumab: 20 mg per dose IV over 8 hours on days -5 to -1. Patients then received infusion of related or unrelated donor peripheral blood progenitor cells on day 0. Patients also receive cyclosporine IV continuously beginning on day -2, continuing (IV or orally) until day 100, followed by a taper.
|
|---|---|
|
Surgical and medical procedures
Hemorrhage/Bleeding
|
15.4%
2/13 • Number of events 3 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Vascular disorders
Thrombosis/embolism (vascular access-related)
|
7.7%
1/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Vascular disorders
Vascular
|
30.8%
4/13 • Number of events 5 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Blood/Bone Marrow
|
38.5%
5/13 • Number of events 63 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
DIC (disseminated intravascular coagulation)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Cardiac General
|
46.2%
6/13 • Number of events 10 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Cardiac Arrhythmia
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Edema: limb
|
30.8%
4/13 • Number of events 9 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Edema: viscera
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Fibrinogen
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Hemoglobin
|
61.5%
8/13 • Number of events 36 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Leukocytes (total WBC)
|
30.8%
4/13 • Number of events 8 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Lymphatics
|
61.5%
8/13 • Number of events 17 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Neutrophils/granulocytes (ANC/AGC)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
Platelets
|
53.8%
7/13 • Number of events 35 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Blood and lymphatic system disorders
PTT (Partial Thromboplastin Time)
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Cardiac troponin T (cTnT)
|
7.7%
1/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Hypertension
|
38.5%
5/13 • Number of events 7 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Hypotension
|
30.8%
4/13 • Number of events 5 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Pericardial effusion (non-malignant)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Supraventricular and nodal arrhythmia
|
15.4%
2/13 • Number of events 4 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Cardiac disorders
Ventricular arrhythmia
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Eye disorders
Death not associated with CTCAE term
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Eye disorders
Ocular/Visual
|
23.1%
3/13 • Number of events 4 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Eye disorders
Vision-photophobia
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Anorexia
|
23.1%
3/13 • Number of events 7 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • Number of events 9 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Dehydration
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Diarrhea
|
15.4%
2/13 • Number of events 3 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Flatulence
|
7.7%
1/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Gastritis (including bile reflux gastritis)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Gastrointestinal
|
46.2%
6/13 • Number of events 33 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Heartburn/dyspepsia
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Nausea
|
46.2%
6/13 • Number of events 22 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Gastrointestinal disorders
Vomiting
|
38.5%
5/13 • Number of events 12 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
General disorders
Constitutional Symptoms
|
53.8%
7/13 • Number of events 33 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
General disorders
Fatigue (asthenia, lethargy, malaise)
|
30.8%
4/13 • Number of events 5 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
General disorders
Fever (in the absence of neutropenia, where neutropenia is defined as ANC >1.0 x="" 10e9=""/L)
|
46.2%
6/13 • Number of events 13 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
General disorders
Insomnia
|
30.8%
4/13 • Number of events 10 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
General disorders
Pain
|
92.3%
12/13 • Number of events 98 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
General disorders
Rigors/chills
|
38.5%
5/13 • Number of events 7 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Immune system disorders
Allergic reaction/hypersensitivity (including drug fever)
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Immune system disorders
Allergic rhinitis (including sneezing, nasal stuffiness, postnasal drip)
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Immune system disorders
Allergy/Immunology
|
23.1%
3/13 • Number of events 6 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Immune system disorders
Autoimmune reaction
|
7.7%
1/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Infections and infestations
Colitis, infectious (e.g., Clostridium difficile)
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Infections and infestations
Infection
|
61.5%
8/13 • Number of events 20 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Infections and infestations
Infection with normal ANC or Grade 1 or 2 neutrophils
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Acidosis (metabolic or respiratory)
|
7.7%
1/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Albumin, serum-low (hypoalbuminemia)
|
23.1%
3/13 • Number of events 12 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Alkaline phosphatase, increased
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
ALT, SGPT (serum glutamic pyruvic transaminase), increased
|
46.2%
6/13 • Number of events 8 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
AST, SGOT(serum glutamic oxaloacetic transaminase), increased
|
46.2%
6/13 • Number of events 7 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Bicarbonate, serum-low
|
15.4%
2/13 • Number of events 10 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Bilirubin (hyperbilirubinemia)
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Calcium, serum-low (hypocalcemia)
|
15.4%
2/13 • Number of events 4 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Creatinine, increased
|
46.2%
6/13 • Number of events 18 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Glucose, serum-high (hyperglycemia)
|
30.8%
4/13 • Number of events 36 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Magnesium, serum-low (hypomagnesemia)
|
53.8%
7/13 • Number of events 40 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Metabolic/Laboratory
|
76.9%
10/13 • Number of events 84 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Phosphate, serum-low (hypophosphatemia)
|
15.4%
2/13 • Number of events 3 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-high (hyperkalemia)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Potassium, serum-low (hypokalemia)
|
53.8%
7/13 • Number of events 19 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-high (hypernatremia)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Sodium, serum-low (hyponatremia)
|
23.1%
3/13 • Number of events 5 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Metabolism and nutrition disorders
Uric acid, serum-high (hyperuricemia)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal/Soft Tissue
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Nervous system disorders
Confusion
|
15.4%
2/13 • Number of events 3 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Nervous system disorders
Dizziness
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Nervous system disorders
Extrapyramidal/involuntary movement/restlessness
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Nervous system disorders
Mood alteration
|
30.8%
4/13 • Number of events 10 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Nervous system disorders
Neurology
|
46.2%
6/13 • Number of events 14 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Nervous system disorders
Neuropathy: sensory
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Nervous system disorders
Speech impairment (e.g., dysphasia or aphasia)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Nervous system disorders
Tremor
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Renal and urinary disorders
Bladder spasms
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Renal and urinary disorders
Cystitis
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Renal and urinary disorders
Renal failure
|
30.8%
4/13 • Number of events 7 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Renal and urinary disorders
Renal/Genitourinary
|
38.5%
5/13 • Number of events 7 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Renal and urinary disorders
Urinary retention (including neurogenic bladder)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea (shortness of breath)
|
15.4%
2/13 • Number of events 7 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage, pulmonary/upper respiratory
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hemorrhage/Bleeding
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.7%
1/13 • Number of events 3 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion (non-malignant)
|
7.7%
1/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary/Upper Respiratory
|
53.8%
7/13 • Number of events 28 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Skin and subcutaneous tissue disorders
Cytokine release syndrome/acute infusion reaction
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Skin and subcutaneous tissue disorders
Dermatology/Skin
|
61.5%
8/13 • Number of events 18 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Skin and subcutaneous tissue disorders
Flushing
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Skin and subcutaneous tissue disorders
Pruritus/itching
|
15.4%
2/13 • Number of events 2 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
|
Skin and subcutaneous tissue disorders
Rash: erythema multiforme (e.g., Stevens-Johnson syndrome, toxic epidermal necrolysis)
|
7.7%
1/13 • Number of events 1 • Adverse event data for this study was collected from January 23, 2006 to April 13, 2009.
Adverse event data was collected and entered into the AZCC database which is password protected. The safety population is defined to be all participants who completed at least 1 day of treatment.
|
Additional Information
Andrew M. Yeager, MD
University of Arizona, Arizona Cancer Center
Phone: 520-626-0662
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place