Trial Outcomes & Findings for Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia (NCT NCT00860574)
NCT ID: NCT00860574
Last Updated: 2021-06-22
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
96 participants
Primary outcome timeframe
At 6 months
Results posted on
2021-06-22
Participant Flow
Participant milestones
| Measure |
Treatment (Allogeneic Transplantation)
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Overall Study
STARTED
|
96
|
|
Overall Study
COMPLETED
|
93
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Allogeneic Transplantation)
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Relapse
|
1
|
Baseline Characteristics
Treosulfan, Fludarabine Phosphate, and Total-Body Irradiation Before Donor Stem Cell Transplant in Treating Patients With High-Risk Acute Myeloid Leukemia, Myelodysplastic Syndrome, Acute Lymphoblastic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Allogeneic Transplantation)
n=96 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
93 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
87 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
96 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsOutcome measures
| Measure |
Treatment (Allogeneic Transplantation)
n=96 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Relapse Incidence
|
18 Participants
|
PRIMARY outcome
Timeframe: At 6 monthsCumulative incidence of NRM at 6 months. NRM includes all deaths without relapse or disease progression.
Outcome measures
| Measure |
Treatment (Allogeneic Transplantation)
n=96 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Non Relapse Mortality (NRM) Incidence
|
6 Participants
|
SECONDARY outcome
Timeframe: 1 year after HCTOutcome measures
| Measure |
Treatment (Allogeneic Transplantation)
n=96 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Non Relapse Mortality Incidence
|
6 Participants
|
SECONDARY outcome
Timeframe: at 2 yearsOutcome measures
| Measure |
Treatment (Allogeneic Transplantation)
n=96 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Overall Survival (OS)
|
71 Participants
|
SECONDARY outcome
Timeframe: at 2 yearsOutcome measures
| Measure |
Treatment (Allogeneic Transplantation)
n=96 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Relapse-free Survival
|
62 Participants
|
SECONDARY outcome
Timeframe: at 6 monthsOutcome measures
| Measure |
Treatment (Allogeneic Transplantation)
n=96 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Incidence of Grades II-IV Acute GVHD
|
57 Participants
|
SECONDARY outcome
Timeframe: at 6 monthsOutcome measures
| Measure |
Treatment (Allogeneic Transplantation)
n=96 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Incidence of Chronic GVHD
|
20 Participants
|
SECONDARY outcome
Timeframe: Day 28 after HCTDonor chimerism was evaluated in peripheral blood T cells
Outcome measures
| Measure |
Treatment (Allogeneic Transplantation)
n=87 Participants
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Median Donor CD3 + T Lymphocyte Chimerism in Peripheral Blood
|
100 percentage of T cells
Interval 88.0 to 100.0
|
Adverse Events
Treatment (Allogeneic Transplantation)
Serious events: 17 serious events
Other events: 68 other events
Deaths: 21 deaths
Serious adverse events
| Measure |
Treatment (Allogeneic Transplantation)
n=96 participants at risk
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Gastrointestinal disorders
Mucositis
|
4.2%
4/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Infections and infestations
Bacterial/sepsis
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Cardiac disorders
Heart failure
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Gut GVHD
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Infections and infestations
Sepsis
|
4.2%
4/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Infections and infestations
VRE bacteremia/sepsis
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Infections and infestations
Disseminated toxoplasmosis
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Infections and infestations
Enterococcal bacteremia/VRE
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Infections and infestations
CMV pneumonia
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Infections and infestations
Aspirgillus
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Cardiac disorders
Hypotension
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome (ARDS)
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia/resp failure
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Intubated secondary to DAH
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure/intubated
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Cardiac arrythmia
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pul.Edema
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Hepatobiliary disorders
Bilirubin
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Hepatobiliary disorders
Liver failure
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Hepatobiliary disorders
AST 2680
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Metabolism and nutrition disorders
Hypoglycemia w/seizures
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Metabolism and nutrition disorders
Hyponatremia
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Diffuse alveolar hemorrhage
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Renal and urinary disorders
Kidney rejection - pre-existing hx kidney transplant
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Renal and urinary disorders
Renal failure/dialysis
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Renal and urinary disorders
Renal failure
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Psychiatric disorders
Apnea
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
Other adverse events
| Measure |
Treatment (Allogeneic Transplantation)
n=96 participants at risk
CONDITIONING REGIMEN: Patients receive fludarabine phosphate IV over 30 minutes on days -6 to day -2 and treosulfan IV over 2 hours on days -6 to day -4. Patients also undergo total-body irradiation on day 0. TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell transplantation or bone marrow transplantation on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV continuously or PO BID on days -1 to 56, followed by a taper until day 180 in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6 and 11.
treosulfan: Given IV
fludarabine phosphate: Given IV
total-body irradiation: Low dose starting at 2Gy
peripheral blood stem cell transplantation: Given IV per institutional standard practice
tacrolimus: Given IV or PO
allogeneic bone marrow transplantation: Given IV per institutional standard practice
allogeneic hematopoietic stem cell transplantation: Given IV per institutional standard practice
methotrexate: Given IV
|
|---|---|
|
Gastrointestinal disorders
Mucositis
|
24.0%
23/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Mucosi
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Infections and infestations
Infections
|
58.3%
56/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Blood and lymphatic system disorders
Deep vein thrombosis
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
General disorders
Fatigue
|
6.2%
6/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
General disorders
Adrenal insufficiency
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.2%
6/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Eye disorders
Retinal central vein occlusion
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
General disorders
Dehydration
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
General disorders
Proximal myopathy
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
General disorders
Steroid induced DM
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
General disorders
LE weakness/deconditioning
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
General disorders
Fall
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Nausea
|
5.2%
5/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Vomiting
|
4.2%
4/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Diarrhea
|
11.5%
11/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Diverticulitis
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Anorexia
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Other
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Musculoskeletal and connective tissue disorders
Pain
|
6.2%
6/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Nervous system disorders
Neuropathic leg pain
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Cardiac disorders
Atrial Fibrillation
|
3.1%
3/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Cardiac disorders
Edema
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Cardiac disorders
Hypotension
|
4.2%
4/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Cardiac disorders
LVEF 35%
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Cardiac disorders
Sinus tachycardia
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
8.3%
8/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.5%
11/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Hepatobiliary disorders
ALT/AST
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Hepatobiliary disorders
ALT
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Hepatobiliary disorders
AST
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Hepatobiliary disorders
t.bili 4.2
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Hepatobiliary disorders
Bilirubin
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Musculoskeletal and connective tissue disorders
Steroid myopathy
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Metabolism and nutrition disorders
Elevated ferritin
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Gastrointestinal disorders
GI bleed
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Psychiatric disorders
Confusion
|
4.2%
4/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Psychiatric disorders
Altered Mental Status
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Renal and urinary disorders
Dysuria
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Renal and urinary disorders
Acute renal failure/creatinine
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Renal and urinary disorders
Creatinine
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Renal and urinary disorders
Renal failure/acidosis
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Nervous system disorders
Syncope
|
2.1%
2/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Nervous system disorders
Peripheral neuropathy
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Psychiatric disorders
Hallucinations
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome (PRES)
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
General disorders
Malnutrition
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
|
Blood and lymphatic system disorders
Thrombotic thrombocytopenic purpura (TTP) coagulation
|
1.0%
1/96 • Toxicities Before Day 100
Toxicities documented per Common Terminology Criteria for Adverse Events (CTCAE) v3.0
|
Additional Information
Joachim Deeg
Fred Hutch/University of Washington Cancer Consortium
Phone: 206.667.5985
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place