Trial Outcomes & Findings for Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML (NCT NCT00702403)
NCT ID: NCT00702403
Last Updated: 2017-08-10
Results Overview
Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
Up to 365 days post-transplant
Results posted on
2017-08-10
Participant Flow
Participant milestones
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
From Consent to Engraftment
STARTED
|
57
|
|
From Consent to Engraftment
Ineligible for Study Drug
|
17
|
|
From Consent to Engraftment
COMPLETED
|
40
|
|
From Consent to Engraftment
NOT COMPLETED
|
17
|
|
From Engraftment to Study Completion
STARTED
|
40
|
|
From Engraftment to Study Completion
Patient Drop-outs
|
27
|
|
From Engraftment to Study Completion
COMPLETED
|
13
|
|
From Engraftment to Study Completion
NOT COMPLETED
|
27
|
Reasons for withdrawal
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
From Consent to Engraftment
Progressive leukemia
|
6
|
|
From Consent to Engraftment
Critically ill
|
2
|
|
From Consent to Engraftment
Corrected QT interval (QTc) >450 msec
|
2
|
|
From Consent to Engraftment
Myocardial infarction
|
1
|
|
From Consent to Engraftment
ANC<1500, plts<20K or hyperbilirubinemia
|
4
|
|
From Consent to Engraftment
Miscellaneous (unanticipated) other
|
2
|
|
From Engraftment to Study Completion
Failed pre-1st dose criteria
|
11
|
|
From Engraftment to Study Completion
Relapse (1 Central Nervous System, 3 BM)
|
4
|
|
From Engraftment to Study Completion
Non-compliance
|
2
|
|
From Engraftment to Study Completion
Adenocarcinoma
|
1
|
|
From Engraftment to Study Completion
Liver GVHD
|
1
|
|
From Engraftment to Study Completion
Suicide
|
1
|
|
From Engraftment to Study Completion
Acute respiratory distress syndrome
|
1
|
|
From Engraftment to Study Completion
Dyspnea (unrelated to nilotinib)
|
1
|
|
From Engraftment to Study Completion
Toxicity attributed to Nilotinib
|
5
|
Baseline Characteristics
Nilotinib and Imatinib Mesylate After Donor Stem Cell Transplant in Treating Patients With ALL or CML
Baseline characteristics by cohort
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
n=40 Participants
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Age, Continuous
|
42.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 365 days post-transplantPopulation: Critical to note are two "intention-to-treat" populations: the 1st (N=57) at time of consent, evolved into the second ITT population (N=40), because 17 subjects lost eligibility to begin relapse prophylaxis at engraftment. A 2nd wave of discontinuations occurred at or after Day 81 when all patients were to be switched from imatinib to nilotinib.
Safety and tolerability of nilotinib therapy in patients with imatinib-sensitive leukemia graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events version 4.0. Treatment safety failure is defined for a patient with imatinib sensitive Ph+ leukemia as the inability to be able to deliver at least 400 milligrams per day of nilotinib in adults, and 230 milligrams/m2 per day in children, for at least 85% of the time interval between 81 and 365 days after transplant. The overall study will be considered successful if nilotinib is deliverable to more than 75% of the study participants at this minimum specified dose intensity.
Outcome measures
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
n=40 Participants
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Number of Participants With Treatment Safety Failure
|
13 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: The analysis population was considered in two ways: first the number of treatment success in the entire cohort (by "intention to treat"), and second the number of treatment successes among only those patients who did not die before 1 year from non-relapse mortality.
To be considered a treatment efficacy success at 1 year posttransplant, the patient's bone marrow must demonstrate complete hematological remission, absence of Philadelphia chromosomes, and not satisfy any of the criteria for treatment failure (\>/= 1% aberrantly expressing marrow blasts by multiparameter flow cytometry, \>5% BCR/ABL in marrow by fluorescent in situ hybridization, or \>1 log rise in peripheral blood BCR/ABL by quantitative polymerase chain reaction (PCR) since day 80).
Outcome measures
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
n=40 Participants
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
The Proportion of Patients at 1 Year With Treatment Efficacy Success
By intention to treat
|
29 Participants
|
|
The Proportion of Patients at 1 Year With Treatment Efficacy Success
Excluding early non-relapse deaths
|
29 Participants
|
SECONDARY outcome
Timeframe: Up to 3 yearsPopulation: Overall Survival (complete follow-up is available out to three years for all patients)
The proportion of study participants alive at 1, 2 and 3 years
Outcome measures
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
n=40 Participants
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Survival
Overall Survival at 1 year
|
31 Participants
|
|
Survival
Overal Survival at 2 years
|
28 Participants
|
|
Survival
Overall Survival at 3 years
|
28 Participants
|
SECONDARY outcome
Timeframe: Up to 1 yearPopulation: Proportion alive without relapse among the total number of patients with minimal residual disease follow-up data
The proportion of study participants alive and without hematologic, cytogenetic or molecular evidence of BCR/ABL-positive leukemia at 1 year
Outcome measures
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
n=40 Participants
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Patients Alive With Out Relapse
|
29 Participants
|
SECONDARY outcome
Timeframe: 1 and 3 yearsPopulation: Proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia among those who did not die from non-relapse causes during the first year, and first 3-years after transplant.
The proportion of patients with hematologic, cytogenetic or molecular relapse of BCR/ABL-positive leukemia
Outcome measures
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
n=40 Participants
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Relapse
Proportion with relapse at 1 year
|
5 Participants
|
|
Relapse
Proportion with relapse at 3 years
|
6 Participants
|
Adverse Events
Single Arm Nilotinib Relapse Prophylaxis
Serious events: 20 serious events
Other events: 31 other events
Deaths: 9 deaths
Serious adverse events
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
n=40 participants at risk
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Hepatobiliary disorders
Acute acalculous cholecystitis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Hepatobiliary disorders
Hepatic Failure
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Hepatobiliary disorders
Transaminitis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Pseudomonas bacteremia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Gram negative rod bacteremia with possible urosepsis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Cytomegalovirus reactivation
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Fever/URI
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Staph Aureus Bacteremia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Alpha-hemolytic Streptococcus
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Staph haemolyticus
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Gram-negative Bacteremia and Septic emboli
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Nodular pneumonia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Bacterial pneumonia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Acute lobular pneumonia with sepsis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Haemophilus Influenza-Rhinovirus
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Pharyngitis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Cardiac disorders
Myocardial Infarction
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Cardiac disorders
Malignant hypertension
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Nausea
|
7.5%
3/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Ascites
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Yeast esophagitis-Odynophagia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Anorexia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Abdominal Cramping
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Headache
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Dehydration
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Transaminitis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Respiratory, thoracic and mediastinal disorders
Apnea
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Respiratory, thoracic and mediastinal disorders
Non-specific interstitial pneumonia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Nervous system disorders
Depressed level of consciousness
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Nervous system disorders
Seizure
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Psychiatric disorders
Confusion
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Psychiatric disorders
Altered mental status
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Psychiatric disorders
Acute encephalopathy
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
General disorders
Death, NOS
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
General disorders
Generalized weakness/fatiuge
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
General disorders
Multiorgan failure
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Renal and urinary disorders
Hemorrhagic cystitis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Renal and urinary disorders
Renal colic
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysesthesia syndrome
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
Other adverse events
| Measure |
Single Arm Nilotinib Relapse Prophylaxis
n=40 participants at risk
Beginning after engraftment and blood count recovery (21 to 28 days after allogeneic stem cell transplant), patients with imatinib-sensitive leukemia receive imatinib mesylate PO QD until day 80 and then nilotinib PO BID on days 81-445. Patients with imatinib-resistant leukemia receive nilotinib PO BID beginning after engraftment and blood count recovery until day 445. Treatment continues in the absence of disease progression or unacceptable toxicity.
|
|---|---|
|
Infections and infestations
Klebsiella pneumonia pyelonephritis and positive urine culture
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Vancomycin resistant enterococcus and positive urine culture
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Bacteremia enterococcus faecalis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Oral candidiasis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
CMV Reactivation
|
17.5%
7/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Coagulase-negative staph
|
7.5%
3/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
CMV Enteritis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Candidal esophagitis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
BK Virus
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Klebsiella and E.Coli and Positive Urine Culture
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
S. epidermidis bacteremia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Pseudomonas maltophilia Bacteremia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
GPC Bacteremia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Infections and infestations
Multiorganism sepsis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
47.5%
19/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Blood and lymphatic system disorders
Anemia
|
17.5%
7/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Blood and lymphatic system disorders
Neutropenia
|
17.5%
7/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Blood and lymphatic system disorders
Lymphocytopenia
|
27.5%
11/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.0%
6/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Blood and lymphatic system disorders
INR Increased
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Blood and lymphatic system disorders
Cytopenia
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Elevated Serum AST/ALT
|
25.0%
10/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Dehydration
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Anorexia/Nausea
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Increased Bilirubin
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Increased Alkaline Phosphate
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Increased creatinine-renal insufficiency
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Metabolism and nutrition disorders
Increased Lipase
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
General disorders
Pain
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
General disorders
Localized Edema
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Musculoskeletal and connective tissue disorders
Generalized Muscle Weakness
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Renal and urinary disorders
Renal Disease
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Renal and urinary disorders
Hematuria
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Psychiatric disorders
Delerium
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Psychiatric disorders
Depression
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Mucositis
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
|
Gastrointestinal disorders
Anorexia
|
2.5%
1/40 • Adverse Events: Conditioning through Day 100; Severe Adverse Events Conditioning >Day 100
|
Additional Information
Dr. Paul A. Carpenter
Fred Hutchinson Cancer Research Center
Phone: (206) 667-5191
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place