Trial Outcomes & Findings for Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma (NCT NCT03623373)
NCT ID: NCT03623373
Last Updated: 2026-04-21
Results Overview
-Stem cell mobilization success is defined as a yield of \>2x10\^6 CD34+ stem cells/kg with a maximum of 5 courses of apheresis
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
Through 5 courses of apheresis (up to 5 days)
Results posted on
2026-04-21
Participant Flow
Participant milestones
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Acalabrutinib With Bendamustine / Rituximab Followed by Cytarabine / Rituximab for Untreated Mantle Cell Lymphoma
Baseline characteristics by cohort
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 Participants
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Age, Continuous
|
57 years
n=13 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=13 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=13 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=13 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=13 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=13 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=13 Participants
|
PRIMARY outcome
Timeframe: Through 5 courses of apheresis (up to 5 days)Population: 9 participants are not evaluable because they did not receive stem cell transplant.
-Stem cell mobilization success is defined as a yield of \>2x10\^6 CD34+ stem cells/kg with a maximum of 5 courses of apheresis
Outcome measures
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=4 Participants
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Stem Cell Mobilization Success Rate With Cytarabine and Rituximab
|
4 Participants
|
SECONDARY outcome
Timeframe: 30 days following completion of treatment (estimated to be 7 months)-Toxicity is measured using NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0
Outcome measures
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 Participants
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Skin infection
|
1 Participants
|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Perirectal abscess
|
1 Participants
|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Peritoneal infection
|
1 Participants
|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Blood bilirubin increased
|
1 Participants
|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Ejection fraction decreased
|
1 Participants
|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Alanine aminotransferase increased
|
1 Participants
|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Diarrhea
|
1 Participants
|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Infusion related reaction
|
1 Participants
|
|
Safety and Tolerability of Regimen in Subjects With MCL as Measured by Treatment Related Non-hematologic Toxicity of Grade 3 or Higher
Upper respiratory infection
|
1 Participants
|
SECONDARY outcome
Timeframe: Through completion of treatment (estimated to be 6 months)-For definitions of CR and PR please refer to the Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
Outcome measures
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 Participants
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Overall Response Rate (ORR = Complete Response (CR) + Partial Response (PR)) of Subjects
|
10 Participants
|
SECONDARY outcome
Timeframe: Through completion of treatment (estimated to be 6 months)-For definitions of CR, please refer to the Recommendations for Initial Evaluation, Staging and Response Assessment of Hodgkin and Non-Hodgkin Lymphoma: The Lugano Classification
Outcome measures
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 Participants
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Pre-transplant Complete Response Rate
|
9 Participants
|
SECONDARY outcome
Timeframe: Up to approximately 5 years of follow-upPopulation: 8 participants were censored due to no progression or death at the last visit.
* Kaplan-Meier estimate of the median time of PFS from start of treatment to time of progression or death, whichever occurs first. * Progressive disease: * London Deauville score of 4 or 5 in individual target nodes/masses with an increase in intensity of uptake from the baseline and/or new FDG avid foci consistent with lymphoma at interim or end of treatment assessment. * New FDG avid foci of extranodal disease consistent with lymphoma. If there is concern regarding the etiology of the new lesions, biopsy or interval scan may be considered * New or recurrent FDG avid foci in the bone marrow
Outcome measures
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 Participants
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Median Progression-free Survival (PFS)
|
67.7 months
Interval 5.63 to
The upper bound is not estimable because only one event reached over median.
|
SECONDARY outcome
Timeframe: Up to approximately 5 years of follow-upPopulation: 9 participants were censored due to being alive at the last visit.
Outcome measures
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 Participants
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Overall Survival (OS)
Deaths
|
4 number of events
|
|
Overall Survival (OS)
Number of censored observations
|
9 number of events
|
SECONDARY outcome
Timeframe: Up to approximately 5 years of follow-up* Overall survival (OS) is defined as the time from study registration to date of death due to any cause. * Kaplan-Meier method will be used for analysis.
Outcome measures
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 Participants
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Median Overall Survival (OS)
|
NA months
Lack of events.
|
Adverse Events
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
Serious events: 8 serious events
Other events: 13 other events
Deaths: 4 deaths
Serious adverse events
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 participants at risk
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Carcinoma of undetermined source
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Flu like symptoms
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Skin infection
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Perirectal abscess
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Infusion related reaction
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Eye disorders
Retinal vein thrombosis
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
Other adverse events
| Measure |
Bendamustine/Rituximab/Acalabrutinib/Cytarabine
n=13 participants at risk
* Patients will receive (6) 28 day cycles
* Cycles 1-3 will consist of bendamustine on Days 1 and 2, rituximab on Day 1, and acalabrutinib twice per day (BID) on Days 1 through 28.
* Cycles 4-6 will consist of rituximab on Day 1, cytarabine every 12 hours on Days 1 and 2, acalabrutinib BID on Days 1 through 7 and 22 through 28 (one week on, two weeks off, one week on), and growth factors as per institutional standard
* After Cycle 6, patients will undergo leukapheresis
|
|---|---|
|
Investigations
White blood cell decreased
|
100.0%
13/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Alkaline phosphatase increased
|
38.5%
5/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Aspartate aminotransferase increased
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Alanine aminotransferase increased
|
30.8%
4/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Creatinine increased
|
38.5%
5/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Anorexia
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
38.5%
5/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
38.5%
5/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
30.8%
4/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Nervous system disorders
Dizziness
|
30.8%
4/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Nervous system disorders
Encephalopathy
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Nervous system disorders
Headache
|
46.2%
6/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Nervous system disorders
Neuralgia
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Nervous system disorders
Syncope
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Nervous system disorders
Dysgeusia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus inflammation
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
46.2%
6/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Keratosis
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Scalp scabs
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Skin and subcutaneous tissue disorders
Diaphoresis
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Psychiatric disorders
Anxiety
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Psychiatric disorders
Depression
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Psychiatric disorders
Hallucinations
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Psychiatric disorders
Insomnia
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Psychiatric disorders
Irritability
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Vascular disorders
Hematoma
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Vascular disorders
Hypotension
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Vascular disorders
Flushing
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Edema limbs
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Malaise
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Fatigue
|
69.2%
9/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Infusion related reaction
|
38.5%
5/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Swelling
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Pain
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Immune system disorders
Allergic reaction
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Upper respiratory infection
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Folliculitis
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Lung infection
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Peritoneal infection
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Urinary tract infection
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Shingles
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Sinusitis
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Infections and infestations
Tooth infection
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Injury, poisoning and procedural complications
Bruising
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Injury, poisoning and procedural complications
Burning sensation at injection site
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Lymphocyte count decreased
|
100.0%
13/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Blood bilirubin increased
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Neutrophil count decreased
|
100.0%
13/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Platelet count decreased
|
100.0%
13/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Investigations
Ejection fraction decreased
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Constipation
|
30.8%
4/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Diarrhea
|
53.8%
7/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Flatulence
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Bloating
|
30.8%
4/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Mucositis oral
|
23.1%
3/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Nausea
|
61.5%
8/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Stomach cramps
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Tooth ache
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Vomiting
|
69.2%
9/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Body aches
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Night sweats
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Chills
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
General disorders
Fever
|
15.4%
2/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Blood and lymphatic system disorders
Anemia
|
92.3%
12/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Cardiac disorders
Palpitations
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Cardiac disorders
Tachycardia
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Eye disorders
Cataract
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.7%
1/13 • Adverse events were collected through 30 days after the last dose of study treatment (approximately 7 months). All-cause mortality was collected up to 5 years.
|
Additional Information
Brad S. Kahl, M.D.
Washington University School of Medicine
Phone: 314-273-3591
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place