Trial Outcomes & Findings for Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL (NCT NCT01754857)
NCT ID: NCT01754857
Last Updated: 2023-06-27
Results Overview
The primary objective is progression-free survival (PFS). Tumor measurements and disease assessments will be performed at the time of screening, following cycles 3 and 6 of induction chemotherapy, every 4 cycles during the maintenance portion of treatment, and at the end of treatment (EOT). Subjects with clinical evidence of progression prior to a planned disease assessment will be evaluated at the time of clinically suspected progression. Follow-up visits for disease assessment will occur every 3 months after the EOT visit until PD, initiation of alternate anti-neoplastic therapy, decision by the subject to withdraw from the study, or death. The follow-up period will begin after the EOT visit, and all subjects will be followed for at least 2 years after completion of therapy or until death or progression and until the last patient has been followed for at least 1 year following completion of therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
36 participants
Primary outcome timeframe
At least 24 months following completion of therapy, an average of 5 years
Results posted on
2023-06-27
Participant Flow
Participant milestones
| Measure |
Bendamustine, Rituximab, Lenalidomide
INDUCTION: Bendamustine 90mg/m2 IV D1\&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity.
MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 \& \<60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Bendamustine: Given IV
Rituximab: Given IV
Lenalidomide: Given PO
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
17
|
|
Overall Study
NOT COMPLETED
|
19
|
Reasons for withdrawal
| Measure |
Bendamustine, Rituximab, Lenalidomide
INDUCTION: Bendamustine 90mg/m2 IV D1\&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity.
MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 \& \<60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Bendamustine: Given IV
Rituximab: Given IV
Lenalidomide: Given PO
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Disease progression
|
3
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
other complicating disease
|
1
|
|
Overall Study
ineligible to continue onto maintenance
|
1
|
|
Overall Study
Patient does not wish to be treated, but will continue to be followed for survival
|
1
|
|
Overall Study
Patient decided not to begin maintenance therapy
|
1
|
Baseline Characteristics
Bendamustine and Rituximab Induction Therapy and Maintenance Rituximab and Lenalidomide in Previously Untreated CLL/SLL
Baseline characteristics by cohort
| Measure |
Bendamustine, Rituximab, Lenalidomide
n=36 Participants
INDUCTION: Bendamustine 90mg/m2 IV D1\&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity.
MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 \& \<60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Bendamustine: Given IV
Rituximab: Given IV
Lenalidomide: Given PO
|
|---|---|
|
Age, Customized
40-49 years
|
1 Participants
n=93 Participants
|
|
Age, Customized
50-59 years
|
7 Participants
n=93 Participants
|
|
Age, Customized
60-69 years
|
19 Participants
n=93 Participants
|
|
Age, Customized
70-79 years
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
27 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
White
|
35 Participants
n=93 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Region of Enrollment
United States
|
36 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: At least 24 months following completion of therapy, an average of 5 yearsPopulation: Time to progression, for which only 30 patients were assessable due to being off study prior to study timepoint
The primary objective is progression-free survival (PFS). Tumor measurements and disease assessments will be performed at the time of screening, following cycles 3 and 6 of induction chemotherapy, every 4 cycles during the maintenance portion of treatment, and at the end of treatment (EOT). Subjects with clinical evidence of progression prior to a planned disease assessment will be evaluated at the time of clinically suspected progression. Follow-up visits for disease assessment will occur every 3 months after the EOT visit until PD, initiation of alternate anti-neoplastic therapy, decision by the subject to withdraw from the study, or death. The follow-up period will begin after the EOT visit, and all subjects will be followed for at least 2 years after completion of therapy or until death or progression and until the last patient has been followed for at least 1 year following completion of therapy.
Outcome measures
| Measure |
Bendamustine, Rituximab, Lenalidomide
n=30 Participants
INDUCTION: Bendamustine 90mg/m2 IV D1\&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity.
MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 \& \<60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Bendamustine: Given IV
Rituximab: Given IV
Lenalidomide: Given PO
|
|---|---|
|
Time to Progression
|
4.76 years
Interval 3.95 to 5.57
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Objective response rate to maintenance, for which only 30 patients were assessable due to being off study prior to study timepoint
To determine objective response rates (CR + PR). As described in the primary objective, formal disease assessments including imaging will be performed after cycles 3 and 6 of induction chemotherapy and every 4 cycles during the maintenance portion of treatment. Response and progression in cases of SLL will be evaluated using the International Working Group Criteria30 for response in lymphoma. Response and progression in cases of CLL will be evaluated in this study using the Revised IWCLL Criteria31 for response in CLL. Radiological methodologies, techniques and/or physical examination, established at baseline for the assessment and measurement of each identified lesion will be used for all subsequent assessments.
Outcome measures
| Measure |
Bendamustine, Rituximab, Lenalidomide
n=30 Participants
INDUCTION: Bendamustine 90mg/m2 IV D1\&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity.
MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 \& \<60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Bendamustine: Given IV
Rituximab: Given IV
Lenalidomide: Given PO
|
|---|---|
|
Objective Response Rates
Complete response
|
12 Participants
|
|
Objective Response Rates
Partial response
|
18 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsTo determine toxicities observed with induction chemotherapy and maintenance therapy. Safety evaluations will be based on the incidence, intensity, and type of adverse events (AEs) and clinical laboratory results. Drug doses will be modified as required based on toxicity as assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Outcome measures
| Measure |
Bendamustine, Rituximab, Lenalidomide
n=36 Participants
INDUCTION: Bendamustine 90mg/m2 IV D1\&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity.
MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 \& \<60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Bendamustine: Given IV
Rituximab: Given IV
Lenalidomide: Given PO
|
|---|---|
|
Count of Events Related to Toxicity
Serious Adverse Events due to toxicities
|
41 toxicity related events
|
|
Count of Events Related to Toxicity
Adverse Events due to toxicities
|
167 toxicity related events
|
Adverse Events
Bendamustine, Rituximab, Lenalidomide
Serious events: 36 serious events
Other events: 36 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Bendamustine, Rituximab, Lenalidomide
n=36 participants at risk
INDUCTION: Bendamustine 90mg/m2 IV D1\&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity.
MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 \& \<60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Bendamustine: Given IV
Rituximab: Given IV
Lenalidomide: Given PO
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
16.7%
6/36 • Number of events 6 • 30 months
|
|
Gastrointestinal disorders
Enterocolitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Ileus
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Typhlitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
General disorders
Fatigue
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
General disorders
Fever
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Hepatobiliary disorders
Cholecystitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Immune system disorders
Cytokine release syndrome
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Infections and infestations
Bronchial infection
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Infections and infestations
Lung infection
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Infections and infestations
Skin infection
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Infections and infestations
Upper respiratory infection
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Alkaline phosphatase increased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Aspartate aminotransferase increased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Blood bilirubin increased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
GGT increased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Lipase increased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Neutrophil count decreased
|
72.2%
26/36 • Number of events 26 • 30 months
|
|
Investigations
Platelet count decreased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
50.0%
18/36 • Number of events 18 • 30 months
|
|
Psychiatric disorders
Depression
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Vascular disorders
Thromboembolic event
|
2.8%
1/36 • Number of events 1 • 30 months
|
Other adverse events
| Measure |
Bendamustine, Rituximab, Lenalidomide
n=36 participants at risk
INDUCTION: Bendamustine 90mg/m2 IV D1\&2 and rituximab IV D1 (up to day 5 of course 1) every 28 days for 6 cycles. Patients with objective response move to maintenance therapy. Patients with objective response after 4 courses are eligible to for maintenance therapy if ongoing induction therapy is associated w/unacceptable toxicity.
MAINTENANCE: At 6-12 wks post induction therapy, patients receive rituximab IV on day 1 of odd-numbered cycles for 24 cycles; lenalidomide 5mg PO daily on days 1-21 of each cycle (28 day cycles). Dose escalation to 10mg daily on days 1-21 allowed at start of cycle 2 or at start of subsequent cycles in subjects w/acceptable toxicities. Lenalidomide dose escalation only allowed at start of a new cycle up to a max dose of 10 mg/day on days 1- 21. Subjects entering maintenance with CrCl ≥40 \& \<60mL/min will begin dosing at 5mg every other day on days 1-21. Patients with excessive toxicity from lenalidomide may continue maintenance therapy with rituximab alone.
Bendamustine: Given IV
Rituximab: Given IV
Lenalidomide: Given PO
|
|---|---|
|
Gastrointestinal disorders
Nausea
|
72.2%
26/36 • Number of events 51 • 30 months
|
|
Gastrointestinal disorders
Constipation
|
66.7%
24/36 • Number of events 41 • 30 months
|
|
Gastrointestinal disorders
Diarrhea
|
66.7%
24/36 • Number of events 53 • 30 months
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
36.1%
13/36 • Number of events 21 • 30 months
|
|
Gastrointestinal disorders
Abdominal pain
|
16.7%
6/36 • Number of events 7 • 30 months
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
6/36 • Number of events 11 • 30 months
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Gastritis
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Stomach pain
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Toothache
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Gastrointestinal disorders
Ascites
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Colitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Enterocolitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Esophagitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Gingival pain
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Ileus
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Mucositis oral
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Oral dysesthesia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Oral pain
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Pancreatitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Gastrointestinal disorders
Typhlitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
General disorders
Fatigue
|
88.9%
32/36 • Number of events 59 • 30 months
|
|
General disorders
General disorders and administration site conditions - Other, specify
|
38.9%
14/36 • Number of events 54 • 30 months
|
|
General disorders
Infusion related reaction
|
33.3%
12/36 • Number of events 14 • 30 months
|
|
General disorders
Edema limbs
|
30.6%
11/36 • Number of events 15 • 30 months
|
|
General disorders
Chills
|
13.9%
5/36 • Number of events 7 • 30 months
|
|
General disorders
Fever
|
11.1%
4/36 • Number of events 7 • 30 months
|
|
General disorders
Non-cardiac chest pain
|
11.1%
4/36 • Number of events 4 • 30 months
|
|
General disorders
Pain
|
11.1%
4/36 • Number of events 5 • 30 months
|
|
General disorders
Localized edema
|
8.3%
3/36 • Number of events 5 • 30 months
|
|
General disorders
Flu like symptoms
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
General disorders
Irritability
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
General disorders
Malaise
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
General disorders
Gait disturbance
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Neutrophil count decreased
|
80.6%
29/36 • Number of events 117 • 30 months
|
|
Investigations
White blood cell decreased
|
63.9%
23/36 • Number of events 97 • 30 months
|
|
Investigations
Lymphocyte count decreased
|
58.3%
21/36 • Number of events 111 • 30 months
|
|
Investigations
Platelet count decreased
|
36.1%
13/36 • Number of events 24 • 30 months
|
|
Investigations
Aspartate aminotransferase increased
|
13.9%
5/36 • Number of events 7 • 30 months
|
|
Investigations
Creatinine increased
|
11.1%
4/36 • Number of events 7 • 30 months
|
|
Investigations
Weight loss
|
11.1%
4/36 • Number of events 13 • 30 months
|
|
Investigations
Alanine aminotransferase increased
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Investigations
Alkaline phosphatase increased
|
8.3%
3/36 • Number of events 5 • 30 months
|
|
Investigations
Blood bilirubin increased
|
8.3%
3/36 • Number of events 4 • 30 months
|
|
Investigations
Investigations - Other, specify
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Investigations
Weight gain
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Investigations
GGT increased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Haptoglobin decreased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Lipase increased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Investigations
Lymphocyte count increased
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Infections and infestations
Upper respiratory infection
|
44.4%
16/36 • Number of events 31 • 30 months
|
|
Infections and infestations
Infections and infestations - Other, specify
|
27.8%
10/36 • Number of events 16 • 30 months
|
|
Infections and infestations
Sinusitis
|
25.0%
9/36 • Number of events 14 • 30 months
|
|
Infections and infestations
Skin infection
|
22.2%
8/36 • Number of events 9 • 30 months
|
|
Infections and infestations
Lung infection
|
13.9%
5/36 • Number of events 15 • 30 months
|
|
Infections and infestations
Enterocolitis infectious
|
11.1%
4/36 • Number of events 6 • 30 months
|
|
Infections and infestations
Phlebitis infective
|
8.3%
3/36 • Number of events 5 • 30 months
|
|
Infections and infestations
Urinary tract infection
|
8.3%
3/36 • Number of events 4 • 30 months
|
|
Infections and infestations
Bronchial infection
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
Infections and infestations
Otitis media
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Infections and infestations
Paronychia
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Infections and infestations
Penile infection
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Infections and infestations
Sepsis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Infections and infestations
Soft tissue infection
|
2.8%
1/36 • Number of events 2 • 30 months
|
|
Infections and infestations
Tooth infection
|
2.8%
1/36 • Number of events 3 • 30 months
|
|
Infections and infestations
Vaginal infection
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
52.8%
19/36 • Number of events 43 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
36.1%
13/36 • Number of events 26 • 30 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
30.6%
11/36 • Number of events 12 • 30 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
30.6%
11/36 • Number of events 13 • 30 months
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Periorbital edema
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Photosensitivity
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Nervous system disorders
Headache
|
44.4%
16/36 • Number of events 26 • 30 months
|
|
Nervous system disorders
Dizziness
|
30.6%
11/36 • Number of events 15 • 30 months
|
|
Nervous system disorders
Dysgeusia
|
25.0%
9/36 • Number of events 9 • 30 months
|
|
Nervous system disorders
Paresthesia
|
11.1%
4/36 • Number of events 4 • 30 months
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.1%
4/36 • Number of events 4 • 30 months
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
Nervous system disorders
Tremor
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Nervous system disorders
Amnesia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Nervous system disorders
Memory impairment
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Nervous system disorders
Neuralgia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Nervous system disorders
Presyncope
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Nervous system disorders
Seizure
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Nervous system disorders
Sinus pain
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
47.2%
17/36 • Number of events 23 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
25.0%
9/36 • Number of events 11 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
16.7%
6/36 • Number of events 8 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify
|
13.9%
5/36 • Number of events 8 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
4/36 • Number of events 4 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.3%
3/36 • Number of events 4 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Postnasal drip
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify
|
27.8%
10/36 • Number of events 17 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
22.2%
8/36 • Number of events 9 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
13.9%
5/36 • Number of events 7 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
13.9%
5/36 • Number of events 6 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
3/36 • Number of events 4 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Buttock pain
|
2.8%
1/36 • Number of events 2 • 30 months
|
|
Musculoskeletal and connective tissue disorders
Joint effusion
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Anorexia
|
22.2%
8/36 • Number of events 10 • 30 months
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
16.7%
6/36 • Number of events 21 • 30 months
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
16.7%
6/36 • Number of events 9 • 30 months
|
|
Metabolism and nutrition disorders
Hypokalemia
|
11.1%
4/36 • Number of events 7 • 30 months
|
|
Metabolism and nutrition disorders
Hyponatremia
|
11.1%
4/36 • Number of events 4 • 30 months
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
Metabolism and nutrition disorders
Dehydration
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Insomnia
|
33.3%
12/36 • Number of events 14 • 30 months
|
|
Psychiatric disorders
Agitation
|
8.3%
3/36 • Number of events 4 • 30 months
|
|
Psychiatric disorders
Anxiety
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Psychiatric disorders
Depression
|
8.3%
3/36 • Number of events 6 • 30 months
|
|
Psychiatric disorders
Psychiatric disorders - Other, specify
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Psychiatric disorders
Restlessness
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Vascular disorders
Hypertension
|
16.7%
6/36 • Number of events 13 • 30 months
|
|
Vascular disorders
Phlebitis
|
16.7%
6/36 • Number of events 9 • 30 months
|
|
Vascular disorders
Hot flashes
|
13.9%
5/36 • Number of events 5 • 30 months
|
|
Vascular disorders
Hematoma
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Vascular disorders
Flushing
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
Vascular disorders
Thromboembolic event
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Vascular disorders
Vascular disorders - Other, specify
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Blood and lymphatic system disorders
Anemia
|
25.0%
9/36 • Number of events 29 • 30 months
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
13.9%
5/36 • Number of events 7 • 30 months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
Eye disorders
Eye disorders - Other, specify
|
13.9%
5/36 • Number of events 5 • 30 months
|
|
Eye disorders
Conjunctivitis
|
11.1%
4/36 • Number of events 5 • 30 months
|
|
Eye disorders
Dry eye
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Eye disorders
Blurred vision
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
Eye disorders
Cataract
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
30.6%
11/36 • Number of events 25 • 30 months
|
|
Renal and urinary disorders
Urinary frequency
|
13.9%
5/36 • Number of events 6 • 30 months
|
|
Renal and urinary disorders
Acute kidney injury
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Renal calculi
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Renal and urinary disorders
Urinary incontinence
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Injury, poisoning and procedural complications
Injury, poisoning and procedural complications - Other, specify
|
11.1%
4/36 • Number of events 4 • 30 months
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
3/36 • Number of events 3 • 30 months
|
|
Injury, poisoning and procedural complications
Bruising
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Injury, poisoning and procedural complications
Fracture
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders - Other, specify
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Ear and labyrinth disorders
Vertigo
|
5.6%
2/36 • Number of events 3 • 30 months
|
|
Ear and labyrinth disorders
Tinnitus
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
8.3%
3/36 • Number of events 5 • 30 months
|
|
Cardiac disorders
Atrial fibrillation
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Cardiac disorders
Sinus tachycardia
|
2.8%
1/36 • Number of events 1 • 30 months
|
|
Immune system disorders
Immune system disorders - Other, specify
|
8.3%
3/36 • Number of events 8 • 30 months
|
|
Immune system disorders
Cytokine release syndrome
|
5.6%
2/36 • Number of events 2 • 30 months
|
|
Surgical and medical procedures
Surgical and medical procedures - Other, specify
|
2.8%
1/36 • Number of events 1 • 30 months
|
Additional Information
Julie Chang, MD
University of Wisconsin Carbone Cancer Center
Phone: 800-622-9822
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place