Trial Outcomes & Findings for Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma (NCT NCT01234467)
NCT ID: NCT01234467
Last Updated: 2017-05-24
Results Overview
Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
23 participants
Primary outcome timeframe
2 years
Results posted on
2017-05-24
Participant Flow
23 patients were enrolled between March 2011 and May 2013.
28 patients were assessed for eligibility; 4 patients were excluded for not meeting the inclusion criteria and 1 patient eventually declined to participate. Leaving 23 patients enrolled.
Participant milestones
| Measure |
Bendamustine, Rituximab
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Overall Study
STARTED
|
23
|
|
Overall Study
COMPLETED
|
11
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
| Measure |
Bendamustine, Rituximab
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Overall Study
Adverse Event
|
3
|
|
Overall Study
Death
|
2
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Disease Progression
|
2
|
|
Overall Study
Clinical deterioration
|
1
|
|
Overall Study
Physician Decision
|
1
|
|
Overall Study
Other complicating disease (stroke)
|
1
|
Baseline Characteristics
Bendamustine + Rituximab in Older Patients With Previously Untreated Diffuse Large B-cell Lymphoma
Baseline characteristics by cohort
| Measure |
Bendamustine, Rituximab
n=23 Participants
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Age, Continuous
|
80 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
23 participants
n=5 Participants
|
|
Stage
II
|
4 Participants
n=5 Participants
|
|
Stage
III
|
7 Participants
n=5 Participants
|
|
Stage
IV
|
12 Participants
n=5 Participants
|
|
ECOG Performance Status
0
|
2 Participants
n=5 Participants
|
|
ECOG Performance Status
1
|
9 Participants
n=5 Participants
|
|
ECOG Performance Status
2
|
6 Participants
n=5 Participants
|
|
ECOG Performance Status
3
|
6 Participants
n=5 Participants
|
|
International Prognostic Index (IPI)
2
|
5 Participants
n=5 Participants
|
|
International Prognostic Index (IPI)
3
|
5 Participants
n=5 Participants
|
|
International Prognostic Index (IPI)
4
|
8 Participants
n=5 Participants
|
|
International Prognostic Index (IPI)
5
|
5 Participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH)
Normal
|
8 Participants
n=5 Participants
|
|
Lactate Dehydrogenase (LDH)
Elevated
|
15 Participants
n=5 Participants
|
|
Pathology Subtype
Non-Germinal Center
|
12 Participants
n=5 Participants
|
|
Pathology Subtype
Germinal Center
|
7 Participants
n=5 Participants
|
|
Pathology Subtype
Not Classified
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
Complete response (CR) is defined as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. The complete response rate is the percentage of participants achieving a CR.
Outcome measures
| Measure |
Bendamustine, Rituximab
n=23 Participants
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Complete Response (CR) Rate as Defined by The International Harmonization Project for Response Criteria
|
52 percentage of participants
Interval 30.6 to 73.2
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
The ORR consists of the complete response rate + the partial response rate (percentage of participants achieving a complete or partial response). Complete response is defined by The International Harmonization Project for Response Criteria as the complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present before therapy. Partial response is defined as regression of measurable disease and no new sites.
Outcome measures
| Measure |
Bendamustine, Rituximab
n=23 Participants
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Overall Response Rate (ORR)
|
78 percentage of participants
|
SECONDARY outcome
Timeframe: 2 yearsPopulation: This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
The percentage of participants achieving a partial response (PR). PR is defined by The International Harmonization Project for Response Criteria as regression of measurable disease and no new sites.
Outcome measures
| Measure |
Bendamustine, Rituximab
n=23 Participants
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Partial Response Rate
|
26 percentage of participants
Interval 10.2 to 48.4
|
SECONDARY outcome
Timeframe: 2 years with the median follow-up of 29 monthsPopulation: This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
Progression-free survival (PFS) will be summarized using the Kaplan-Meier method. PFS was defined as the time from the start of treatment until lymphoma progression or death as a result of any cause. Progression was defined by The International Harmonization Project for Response Criteria as any new lesion or increase by ≥50% of previously involved sites from nadir.
Outcome measures
| Measure |
Bendamustine, Rituximab
n=23 Participants
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Estimate of Progression-Free Survival
|
5.4 Months
Interval 3.8 to 10.2
|
SECONDARY outcome
Timeframe: 2 years with the median follow-up of 29 monthsPopulation: This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
This represents the Kaplan-Meier estimates of median overall survival defined as the time from start of treatment until death as a result of any cause.
Outcome measures
| Measure |
Bendamustine, Rituximab
n=23 Participants
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Overall Survival
|
10.2 Months
Interval 3.8 to 13.3
|
SECONDARY outcome
Timeframe: Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.Population: This represents the data after inclusion of the first 23 patients at the planned interim analysis. The data analysis was performed prior to the previously determined 3-year follow-up period because the study did not reach the initially planned sample size to determine the survival rates in a statistically significant manner as secondary objectives.
The major grade 3 or higher adverse events were haematological toxicities. The results below include common haematological and non-haematological toxicities of grade 3 or higher. A complete record of all adverse events are reported in the adverse events section. National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE), version 4.0 were used to assess toxicity.
Outcome measures
| Measure |
Bendamustine, Rituximab
n=23 Participants
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Lymphopenia
|
70 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Anemia
|
26 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Neutropenia
|
17 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Thrombocytopenia
|
17 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Lymphocytosis
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Fatigue
|
13 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Anorexia
|
9 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Hyperglycemia
|
9 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Urinary Tract Infection
|
9 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Arthralgia
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Atrial Fibrillation
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Cognitive Disturbance
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Generalized Muscle Weakness
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Heart Failure
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Hypoalbuminemia
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Hyponatremia
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Infusion Related Reaction
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Myalgia
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Nausea
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Pleural Effusion
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Maculopapular Rash
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Sepsis
|
4 percentage of patients
|
|
Evaluate the Toxicity and Tolerability of Bendamustine in Combination With Rituximab
Skin Infection
|
4 percentage of patients
|
Adverse Events
Bendamustine, Rituximab
Serious events: 15 serious events
Other events: 23 other events
Deaths: 17 deaths
Serious adverse events
| Measure |
Bendamustine, Rituximab
n=23 participants at risk
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Death NOS
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Cardiac disorders
Heart failure
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Infections and infestations
Lung infection
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Neutrophil count decreased
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Platelet count decreased
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Infections and infestations
Sepsis
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Cognitive Disturbance
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Creatinine increased
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Duodenal hemorrhage
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Fever
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Gastric hemorrhage
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Non-cardiac chest pain
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Infections and infestations
Skin infection
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Stroke
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Vascular disorders
Thromboembolic event
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Infections and infestations
Urinary tract infection
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
Other adverse events
| Measure |
Bendamustine, Rituximab
n=23 participants at risk
This is a single arm intervention where patients will receive bendamustine at a dose of 120 mg/m\^2 infused over 60 minutes in days 1 and 2 of each 21 day cycle along with rituximab 375 mg/m\^2 after bendamustine on day 1 of each cycle. Patients with Eastern Cooperative Oncology Group (ECOG) PS of 3 at baseline were allowed to receive bendamustine at a dose of 90 mg/m\^2 daily with a dose increase to 120 mg/m\^2 daily if their ECOG improved.
Bendamustine: Dosage Form: Intravenous (60 minute infusion) Dosage: 120mg/m2 (ECOG = 0-2) or 90mg/m2 (ECOG = 3) Frequency: Day 1 and Day 2; Every 3 weeks of a 21 day cycle. Duration: 3-6 Cycles
Rituximab: Dosage form: Intravenous Dosage: 375 mg/m2 Frequency: Day 1 of every 3 weeks of a 21 day Cycle Duration: 3-6 Cycles
|
|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Alanine aminotransferase increased
|
21.7%
5/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Alkaline phosphatase increased
|
56.5%
13/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Alkalosis
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Blood and lymphatic system disorders
Anemia
|
87.0%
20/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Anorexia
|
60.9%
14/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Aspartate aminotransferase increased
|
60.9%
14/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Cardiac disorders
Atrial fibrillation
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Blood bilirubin increased
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Cardiac troponin I increased
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Cardiac disorders
Chest pain - cardiac
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Colitis
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Psychiatric disorders
Confusion
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Constipation
|
30.4%
7/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Creatinine increased
|
43.5%
10/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Dehydration
|
17.4%
4/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Diarrhea
|
34.8%
8/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Dizziness
|
17.4%
4/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Dysgeusia
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Dyspepsia
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
26.1%
6/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Edema face
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Edema limbs
|
17.4%
4/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Ejection fraction decreased
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
17.4%
4/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Fatigue
|
87.0%
20/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Fever
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Vascular disorders
Flushing
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Headache
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Renal and urinary disorders
Hemoglobinuria
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
43.5%
10/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hyperkalemia
|
26.1%
6/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hypermagnesemia
|
26.1%
6/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hypernatremia
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Hypersomnia
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Vascular disorders
Hypertension
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
82.6%
19/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
43.5%
10/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
43.5%
10/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
39.1%
9/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
43.5%
10/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
26.1%
6/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Vascular disorders
Hypotension
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Infections and infestations
Infections and infestations - Other, specify
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Infusion related reaction
|
17.4%
4/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
INR increased
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Psychiatric disorders
Insomnia
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Lethargy
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Infections and infestations
Lip infection
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Localized edema
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Lymphocyte count decreased
|
73.9%
17/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders - Other, specify
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Infections and infestations
Mucosal infection
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Mucositis oral
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness lower limb
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Nausea
|
47.8%
11/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) - Other, specify
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Nervous system disorders - Other, specify
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Neutrophil count decreased
|
43.5%
10/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Oral pain
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
General disorders
Pain
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
17.4%
4/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Nervous system disorders
Paresthesia
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Platelet count decreased
|
65.2%
15/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Renal and urinary disorders
Proteinuria
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash acneiform
|
13.0%
3/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Psychiatric disorders
Restlessness
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Skin and subcutaneous tissue disorders
Skin ulceration
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor pain
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Renal and urinary disorders
Urinary frequency
|
8.7%
2/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Infections and infestations
Urinary tract infection
|
26.1%
6/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Voice alteration
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
26.1%
6/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Weight loss
|
30.4%
7/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
White blood cell decreased
|
60.9%
14/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
|
Investigations
Lymphocyte count increased
|
4.3%
1/23 • Adverse events were collected while patients were on active treatment. The median treatment time was 18 weeks.
|
Additional Information
Robin V. Johnson
UNC Lineberger Comprehensive Cancer Center
Phone: 919-966-1125
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60