Trial Outcomes & Findings for Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma (NCT NCT03019640)
NCT ID: NCT03019640
Last Updated: 2023-02-16
Results Overview
Participants that had Treatment-related mortality within 30 days.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
22 participants
Primary outcome timeframe
Up to 30 days
Results posted on
2023-02-16
Participant Flow
Participants recruitment from October 2017 to August 2021 at MD Anderson Cancer Center.
Participant milestones
| Measure |
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.
|
|---|---|
|
Overall Study
STARTED
|
22
|
|
Overall Study
COMPLETED
|
14
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.
|
|---|---|
|
Overall Study
Screen Failures
|
4
|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Participant Relapsed
|
1
|
Baseline Characteristics
Umbilical Cord Blood NK Cells, Rituximab, High-Dose Chemotherapy, and Stem Cell Transplant in Treating Patients With Recurrent or Refractory B-Cell Non-Hodgkin's Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
n=22 Participants
Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
17 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 30 daysPopulation: Four participants did not received treatment due to screen failures.
Participants that had Treatment-related mortality within 30 days.
Outcome measures
| Measure |
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
n=18 Participants
See Detailed Description.
Autologous Hematopoietic Stem Cell Transplantation: Undergo stem cell transplant
Carmustine: Given IV
Cord Blood-derived Expanded Allogeneic Natural Killer Cells: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Lenalidomide: Given PO
Melphalan: Given IV
Rituximab: Given IV
|
|---|---|
|
Treatment-related Mortality Within 30 Days (TRM30)
|
0 Participants
|
SECONDARY outcome
Timeframe: From the time of transplant, assessed up to day 180Number of Participants Who Survived at day 180.
Outcome measures
| Measure |
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
n=22 Participants
See Detailed Description.
Autologous Hematopoietic Stem Cell Transplantation: Undergo stem cell transplant
Carmustine: Given IV
Cord Blood-derived Expanded Allogeneic Natural Killer Cells: Given IV
Cytarabine: Given IV
Etoposide: Given IV
Filgrastim: Given SC
Lenalidomide: Given PO
Melphalan: Given IV
Rituximab: Given IV
|
|---|---|
|
Number of Participants Who Survived
|
16 Participants
|
Adverse Events
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
Serious events: 15 serious events
Other events: 22 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
n=22 participants at risk
Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.
|
|---|---|
|
Hepatobiliary disorders
Alanine aminotransferase increased
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Blood and lymphatic system disorders
Anemia
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Hepatobiliary disorders
Aspartate aminotransferase increased
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Cardiac disorders
Hypotension
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Hepatobiliary disorders
Hypoxia
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Infections and infestations
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Lung
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Blood and lymphatic system disorders
Lymphocyte count decreased
|
40.9%
9/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Blood and lymphatic system disorders
Neutrophil count decreased
|
54.5%
12/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Blood and lymphatic system disorders
Platelet count decreased
|
54.5%
12/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Blood and lymphatic system disorders
White blood cell decreased
|
68.2%
15/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
Other adverse events
| Measure |
Treatment (Chemotherapy, NK Infusion, Stem Cell Transplant)
n=22 participants at risk
Patients receive carmustine intravenously (IV) over 2 hours on day -12, etoposide IV twice daily (BID) over 3 hours on days -11 to -8, cytarabine IV BID over 1 hour on days -11 to -8, melphalan IV over 30 minutes on day -7, and lenalidomide orally (PO) once daily (QD) on days -7 to -2 in the absence of disease progression or unacceptable toxicity. Patients who are CD20+ also receive rituximab IV over 3 hours on days -13 and -7.
|
|---|---|
|
General disorders
Abdominal pain
|
18.2%
4/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Injury, poisoning and procedural complications
Acute kidney injury
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Alanine aminotransferase increased
|
45.5%
10/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Alkaline phosphatase increased
|
27.3%
6/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
18.2%
4/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Blood and lymphatic system disorders
Anemia
|
100.0%
22/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Anorexia
|
59.1%
13/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Psychiatric disorders
Anxiety
|
36.4%
8/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Immune system disorders
Arthralgia
|
22.7%
5/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Aspartate aminotransferase increased
|
27.3%
6/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Cardiac disorders
Atrial fibrillation
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Injury, poisoning and procedural complications
Back pain
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Bladder infection
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Bloating
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Blood bilirubin increased
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Chills
|
31.8%
7/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Cholesterol high
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Constipation
|
54.5%
12/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Cough
|
31.8%
7/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Creatinine increased
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Dehydration
|
18.2%
4/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Diarrhea
|
95.5%
21/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Immune system disorders
Dizziness
|
40.9%
9/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Nervous system disorders
Dysgeusia
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Dysphagia
|
22.7%
5/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
18.2%
4/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Ear and labyrinth disorders
Ear pain
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Edema face
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Edema limbs
|
54.5%
12/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Hepatobiliary disorders
Encephalopathy
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Endocrine disorders
Endocrine disorders
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Esophagitis
|
22.7%
5/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Eye disorders
Eye disorders
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Fatigue
|
77.3%
17/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
31.8%
7/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Fever
|
100.0%
22/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Flatulence
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Immune system disorders
Flushing
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Gastrointestinal pain
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
General disorders and administration site conditions
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
18.2%
4/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Nervous system disorders
Headache
|
50.0%
11/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Renal and urinary disorders
Hematuria
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Hemorrhoidal hemorrhage
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Hemorrhoids
|
18.2%
4/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
22.7%
5/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
81.8%
18/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Hypertension
|
31.8%
7/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
45.5%
10/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
45.5%
10/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
40.9%
9/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
22.7%
5/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
36.4%
8/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
54.5%
12/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Vascular disorders
Hypotension
|
59.1%
13/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Endocrine disorders
Hypothyroidism
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Hypoxia
|
18.2%
4/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Ileus
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Immune system disorders
Immune system disorders
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Infections and infestations
|
22.7%
5/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Infusion related reaction
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
INR increased
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Psychiatric disorders
Insomnia
|
31.8%
7/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Investigations
|
31.8%
7/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Lung infection
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
22/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Lymphocyte count increased
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Mucosal infection
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Mucositis oral
|
77.3%
17/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
22/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Nervous system disorders
Nervous system disorders
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Neutrophil count decreased
|
100.0%
22/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Non-cardiac chest pain
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
General disorders
Pain
|
27.3%
6/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Papulopustular rash
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Nervous system disorders
Paresthesia
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Platelet count decreased
|
100.0%
22/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
54.5%
12/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Rectal pain
|
13.6%
3/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Renal and urinary disorders
Renal and urinary disorders
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Nervous system disorders
Restlessness
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Cardiac disorders
Sinus bradycardia
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Cardiac disorders
Sinus tachycardia
|
63.6%
14/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Sinusitis
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorder
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Vascular disorders
Thromboembolic event
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Nervous system disorders
Tremor
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
2/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Renal and urinary disorders
Urinary frequency
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Renal and urinary disorders
Urinary tract infection
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Renal and urinary disorders
Urinary tract pain
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Vascular disorders
Vascular disorders
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Gastrointestinal disorders
Vomiting
|
31.8%
7/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
Weight gain
|
4.5%
1/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
|
Investigations
White blood cell decreased
|
100.0%
22/22 • All-Cause Mortality monitored/assessed up to 180 days.
|
Additional Information
UT MD Anderson Cancer Center
Yago Nieto, PhD / Stem Cell Transplantation Department
Phone: 713-792-8750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place