Trial Outcomes & Findings for Clofarabine, Cytarabine, and Thymoglobulin for Allogeneic Transplantation (NCT NCT00593645)
NCT ID: NCT00593645
Last Updated: 2014-09-12
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
7 participants
Primary outcome timeframe
6 months
Results posted on
2014-09-12
Participant Flow
Enrollment to the study opened on 11/21/2007 and enrollment to the study closed on 08/11/2008
Participant milestones
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clofarabine, Cytarabine, and Thymoglobulin for Allogeneic Transplantation
Baseline characteristics by cohort
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=7 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=99 Participants
|
|
Diagnosis
Myelodysplastic syndrome
|
3 participants
n=99 Participants
|
|
Diagnosis
Acute myeloid leukemia
|
4 participants
n=99 Participants
|
|
Age, Continuous
|
54 years
n=99 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: This outcome was not analyzed. Enrollment to the trial was halted after three of the first seven patients expired. This fulfilled the predefined stopping rule as it was unlikely that we would achieve our primary end point of a 6 month treatment-related mortality of 10%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: One, three, six and twelve months.Population: This outcome was not analyzed due to terminating the study after 7 participants were enrolled. We felt that the engraftment as measured by percent donor chimerism provided better response details than the limited data that was collected for the disease specific partial and complete response rates.
Disease-specific partial response and complete response.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day +30Population: 2 participants were not analyzed because they expired prior to Day +30.
Outcome measures
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=5 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Engraftment as Measured by Percent Donor Chimerism
Not done
|
2 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
50% donor (bone marrow)
|
1 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
100% donor (bone marrow)
|
1 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
23.5% donor (FISH)
|
1 participants
|
SECONDARY outcome
Timeframe: Day +40-+60Population: 3 participants were not analyzed because they were expired.
Outcome measures
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=4 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Engraftment as Measured by Percent Donor Chimerism
60% donor (bone marrow)
|
1 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
70% donor (bone marrow)
|
1 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
75% donor (bone marrow)
|
1 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
100% donor (peripheral blood)
|
1 participants
|
SECONDARY outcome
Timeframe: Day +80-+90Population: 3 participants were not analyzed as they were deceased.
Outcome measures
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=4 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Engraftment as Measured by Percent Donor Chimerism
0% donor
|
1 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
33% donor - myeloid (peripheral blood)
|
1 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
67% donor (bone marrow)
|
1 participants
|
|
Engraftment as Measured by Percent Donor Chimerism
100% donor (bone marrow)
|
1 participants
|
SECONDARY outcome
Timeframe: 5 years from time of restagingOutcome measures
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=7 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Overall Survival
|
237 days
Interval 15.0 to 443.0
|
SECONDARY outcome
Timeframe: 5 years from time of restagingPopulation: None of the patients analyzed survived without any signs or symptoms of that cancer.
Disease-free survival is defined as the length of time after treatment ends that the participant survives without any signs or symptoms of that cancer.
Outcome measures
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=7 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Disease-free Survival
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 100 days after transplantAcute GVHD occurs within 100 days of transplant.
Outcome measures
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=7 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Rate of Acute Graft-versus-host Disease (GVHD)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: 100 days-1 year after transplantPopulation: None of the participants had chronic graft-versus-host disease (GVHD). 3 participants expired prior to day 100.
Outcome measures
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=4 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Rate of Chronic Graft-versus-host Disease (GVHD)
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to 1 year after transplantPopulation: This outcome was not analyzed specifically as the conventional STR-PCR method was used for monitoring engraftment.
Includes assessment of mixed chimerism in the whole blood, myeloid cells, T cells, and B cells.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 5 years from time of restagingPopulation: Of the four surviving patients, three relapsed. One patient remained in remission on day +120.
Time to progression is defined as the length of time from the start of treatment until the disease starts to get worse or spread to other parts of the body.
Outcome measures
| Measure |
Arm 1: Non-myeloablative Conditioning Regimen
n=3 Participants
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Median Time to Progression
|
152 days
Interval 98.0 to 154.0
|
Adverse Events
Arm 1
Serious events: 5 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=7 participants at risk
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Investigations
Bilirubin
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Cardiac disorders
Chest pain
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Death - respiratory failure
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Infections and infestations
Infection with Gr. 3/4 neutropenia
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Mucositis
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Perforation, GI - colon
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Cardiac disorders
Pericardial effusion
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Nervous system disorders
Seizure
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Metabolism and nutrition disorders
Uric acid
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
General disorders
Death due to disease progression
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
Other adverse events
| Measure |
Arm 1
n=7 participants at risk
* Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2
* Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.
* Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.
* Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused.
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Renal and urinary disorders
Acute renal failure
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Alkaline phosphatase
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Metabolism and nutrition disorders
Anorexia
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Cardiac disorders
Atrial fibrillation
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Blood blister - chin
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Eye disorders
Blurred vision
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Injury, poisoning and procedural complications
Bruising
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Nervous system disorders
CNS hemorrhage
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Injury, poisoning and procedural complications
Catheter site
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Cardiac disorders
Chest pain
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Renal and urinary disorders
Cystitis
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Dental: teeth
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Diarrhea
|
100.0%
7/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Distension/bloating
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Nervous system disorders
Dizziness
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Dysgeusia/taste alteration
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Eye disorders
Edema - right eyelid
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
General disorders
Edema:limb
|
100.0%
7/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Elevated creatinine
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Elevated uric acid
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Musculoskeletal and connective tissue disorders
Extremity pain
|
100.0%
7/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Eye disorders
Eye hemorrage
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
General disorders
Fatigue
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
General disorders
Fever in the absence of neutropenia
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Flatulence
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Gastritis
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
General disorders
Generalized edema
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
General disorders
Generalized pain
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
General disorders
Generalized weakness
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Hand-foot reaction
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Ear and labyrinth disorders
Hard of hearing
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Nervous system disorders
Headache
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Eye disorders
Hemianopsia
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hemoglobin
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Hemorrhoids
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Vascular disorders
Hot flashes
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hyperbilirubinemia
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hyperglycemia
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hyperkalemia
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hypermagnesemia
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hypernatremia
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Hyperpigmentation
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Cardiac disorders
Hypertension
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hypoalbuminemia
|
85.7%
6/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hypocalcemia
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hypoglycemia
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hypokalemia
|
85.7%
6/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hypomagnesemia
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Hyponatremia
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Cardiac disorders
Hypotension
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Infections and infestations
Infection with Gr. 3-4 neutrophils
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Infections and infestations
Infection with normal neutrophils
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Infections and infestations
Infectious colitis
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Psychiatric disorders
Insomnia
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Eye disorders
Keratitis
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Leukocytes (WBC)
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Leukoplakia
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Line erythema/ecchymosis
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Infections and infestations
Liver abscess
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Lower gastrointestinal hemorrhage (NOS)
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Lymphopenia
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Psychiatric disorders
Mental status change
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Mucositis
|
85.7%
6/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Nausea
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Musculoskeletal and connective tissue disorders
Neck/chin pain
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Nervous system disorders
Neuropathy - sensory
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Infections and infestations
Neutropenic fever
|
100.0%
7/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Neutrophils
|
71.4%
5/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
Platelets
|
57.1%
4/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis/pulmonary infiltrates
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Eye disorders
Poor vision
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Pruritis/itching
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Nervous system disorders
Ptosis
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Rash/desquamation
|
85.7%
6/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Musculoskeletal and connective tissue disorders
Right-sided weakness
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
General disorders
Rigors/chills
|
85.7%
6/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
SGOT (AST)
|
100.0%
7/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Investigations
SGPT (ALT)
|
100.0%
7/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Skin and subcutaneous tissue disorders
Scrotal chafing
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Cardiac disorders
Sinus bradycardia
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Nervous system disorders
Somnolence
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Cardiac disorders
Tachycardia
|
42.9%
3/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Renal and urinary disorders
Urinary frequency/urgency
|
28.6%
2/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Renal and urinary disorders
Urinary hesitancy
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Renal and urinary disorders
Urinary incontinence
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Renal and urinary disorders
Urinary retention
|
14.3%
1/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
|
Gastrointestinal disorders
Vomiting
|
85.7%
6/7 • Adverse event collection started from the beginning of treatment through 1 year post transplant.
|
Additional Information
Ravi Vij, M.D.
Washington University School of Medicine
Phone: 314-454-8304
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place