Trial Outcomes & Findings for A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment (NCT NCT01596621)
NCT ID: NCT01596621
Last Updated: 2023-05-26
Results Overview
The ORR was defined as the percentage of participants who achieved a best response of complete response (CR) or partial response (PR) during the study based on the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on computed tomography (CT); spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
102 participants
Primary outcome timeframe
From the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years)
Results posted on
2023-05-26
Participant Flow
Participant milestones
| Measure |
Bendamustine
Participants received bendamustine hydrochloride administered at 120 milligrams (mg)/square meter (m\^2) intravenously (IV) as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Overall Study
STARTED
|
102
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
102
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
78
|
Reasons for withdrawal
| Measure |
Bendamustine
Participants received bendamustine hydrochloride administered at 120 milligrams (mg)/square meter (m\^2) intravenously (IV) as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Overall Study
Death
|
4
|
|
Overall Study
Withdrawal by Subject
|
9
|
|
Overall Study
Disease Progression
|
49
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Other than specified
|
13
|
Baseline Characteristics
A Study of Bendamustine in the Treatment of Chinese Participants With Indolent Non-Hodgkin Lymphoma Refractory to Rituximab Treatment
Baseline characteristics by cohort
| Measure |
Bendamustine
n=102 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Age, Continuous
|
52.7 years
STANDARD_DEVIATION 13.24 • n=93 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
62 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=93 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
|
Race/Ethnicity, Customized
Asian
|
102 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: From the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years)Population: The primary analysis set (PAS) included all enrolled participants who were treated with any amount of study drug.
The ORR was defined as the percentage of participants who achieved a best response of complete response (CR) or partial response (PR) during the study based on the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on computed tomography (CT); spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen.
Outcome measures
| Measure |
Bendamustine
n=102 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Overall Response Rate (ORR) (Assessed by Independent Review Committee [IRC])
|
73 percentage of participants
|
SECONDARY outcome
Timeframe: From the date of first documentation of response to the first documentation of disease progression, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years)Population: The PAS included all enrolled participants who were treated with any amount of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Duration of response was defined as the time from the date of first documentation of response to the first documentation of disease progression, new anticancer therapy, or death (regardless of cause), whichever occurred first for participants with a best response of CR or PR determined by the modified International Workshop Response Criteria. CR: disappearance of all evidence of disease; nodal masses regression on normal size on CT; spleen and liver not palpable and nodule disappeared; bone marrow infiltrate cleared on repeat biopsy. PR: Regression of measurable disease and no new sites; nodal masses ≥50% decrease in SPD of up to 6 largest dominant masses and no increase in size of other nodes; spleen and liver ≥50% decrease in SPD of nodules and no increase in size of liver or spleen. Disease progression: any new lesion or increase by ≥50% of previously involved sites from nadir.
Outcome measures
| Measure |
Bendamustine
n=74 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Duration of Response (DOR) (Assessed by IRC)
|
16.2 months
Interval 9.3 to
Due to smaller number of participants with an event the upper limit of 95% confidence interval (CI) could not be calculated.
|
SECONDARY outcome
Timeframe: From the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first (up to 2.5 Years)Population: The PAS included all enrolled participants who were treated with any amount of study drug.
Progression free survival was defined as the time from the date of the first administration of bendamustine to the first documentation of disease progression/relapse, new anticancer therapy, or death (regardless of cause), whichever occurred first for all participants. Disease progression/relapse: appearance of any new lesion or increase by ≥50% of previously involved sites from nadir.
Outcome measures
| Measure |
Bendamustine
n=102 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Progression-Free Survival (Assessed by IRC)
|
18.6 months
Interval 12.3 to
Due to smaller number of participants with an event the upper limit of 95% CI could not be calculated.
|
SECONDARY outcome
Timeframe: Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days)Population: The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated.
Outcome measures
| Measure |
Bendamustine
n=15 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Bendamustine
|
3909.9 nanograms (ng)/milliliters (mL)
Standard Deviation 2995.83
|
SECONDARY outcome
Timeframe: Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days)Population: The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated.
Outcome measures
| Measure |
Bendamustine
n=15 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Time to Reach Cmax (Tmax) of Bendamustine
|
1.30 hours
Interval 0.58 to 1.97
|
SECONDARY outcome
Timeframe: Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days)Population: The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated.
Outcome measures
| Measure |
Bendamustine
n=15 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to the Time of the Last Measurable Drug Concentration (AUC0-t) of Bendamustine
|
5660.7 ng*hour/mL
Standard Deviation 3932.45
|
SECONDARY outcome
Timeframe: Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days)Population: The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bendamustine
n=10 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Area Under the Plasma Concentration Versus Time Curve From Time 0 to Infinity (AUC0-∞) of Bendamustine
|
6278.7 ng*hour/mL
Standard Deviation 4724.82
|
SECONDARY outcome
Timeframe: Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days)Population: The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bendamustine
n=10 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Rate Constant for Elimination (λz) of Bendamustine
|
0.4525 1/hour
Standard Deviation 0.24245
|
SECONDARY outcome
Timeframe: Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days)Population: The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bendamustine
n=10 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Percentage of the AUC0-∞ Based on Extrapolation (%AUCext)
|
0.01 percentage of AUC0-∞
Standard Deviation 0.004
|
SECONDARY outcome
Timeframe: Prior to the start of infusion on Day 1 for up to 24 hours after the end of infusion during Cycle 1 (each cycle is 21 days)Population: The pharmacokinetic analysis set included all enrolled participants who were treated with any amount of study drug and for whom at least 1 pharmacokinetic parameter was calculated. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Outcome measures
| Measure |
Bendamustine
n=10 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Half-Life (t½) of Bendamustine
|
1.83 hours
Standard Deviation 0.684
|
SECONDARY outcome
Timeframe: From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)Population: Safety analysis set included all enrolled participants who were treated with any amount of study drug.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-serious AEs. A summary of other non-serious AEs and all SAEs, regardless of causality is located in the 'Reported AE section'.
Outcome measures
| Measure |
Bendamustine
n=102 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
101 Participants
|
SECONDARY outcome
Timeframe: At the end of treatment (up to 2.5 years)Population: The PAS included all enrolled participants who were treated with any amount of study drug. Here, 'Overall number of participants analyzed' = participants evaluable for this outcome measure.
Number of participants with WHO performance status (improved, stayed the same, and deteriorated) at the end of treatment have been reported.
Outcome measures
| Measure |
Bendamustine
n=86 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
World Health Organization (WHO) Performance Status
Improved
|
6 Participants
|
|
World Health Organization (WHO) Performance Status
Stayed the same
|
73 Participants
|
|
World Health Organization (WHO) Performance Status
Deteriorated
|
7 Participants
|
SECONDARY outcome
Timeframe: From first administration of bendamustine up to the end of treatment (up to 2.5 Years)Population: The PAS included all enrolled participants who were treated with any amount of study drug.
Outcome measures
| Measure |
Bendamustine
n=102 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Number of Participants Who Need At Least 1 Hematologic Supportive Care (Plasma, Blood Cells, or Cytokines)
|
71 Participants
|
SECONDARY outcome
Timeframe: From first administration of bendamustine up to the end of treatment (up to 2.5 Years)Population: Safety analysis set included all enrolled participants who were treated with any amount of study drug.
Concomitant medications included all medications taken while the participant received study drug.
Outcome measures
| Measure |
Bendamustine
n=102 Participants
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Number of Participants With Concomitant Medication Usage
|
102 Participants
|
Adverse Events
Bendamustine
Serious events: 30 serious events
Other events: 99 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Bendamustine
n=102 participants at risk
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.0%
2/102 • Number of events 2 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
2.9%
3/102 • Number of events 3 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
General disorders
Multi-organ failure
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
General disorders
Pyrexia
|
4.9%
5/102 • Number of events 5 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Gastrointestinal infection
|
2.0%
2/102 • Number of events 2 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Hepatitis B
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Herpes virus infection
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Herpes zoster
|
2.9%
3/102 • Number of events 3 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Lung infection
|
3.9%
4/102 • Number of events 4 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Pneumonia
|
4.9%
5/102 • Number of events 6 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Neutrophil count decreased
|
2.0%
2/102 • Number of events 2 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Platelet count decreased
|
2.0%
2/102 • Number of events 2 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
White blood cell count decreased
|
0.98%
1/102 • Number of events 2 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
White blood cell count increased
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic neoplasm
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Nervous system disorders
Epilepsy
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Renal and urinary disorders
Renal impairment
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
3.9%
4/102 • Number of events 4 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.98%
1/102 • Number of events 1 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
Other adverse events
| Measure |
Bendamustine
n=102 participants at risk
Participants received bendamustine hydrochloride administered at 120 mg/m\^2 IV as a 60-minute infusion, and not more than 120 minutes, on Days 1 and 2 in each 21-day treatment cycle for 6 planned cycles and up to 8 total cycles.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
25.5%
26/102 • Number of events 91 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Blood and lymphatic system disorders
Leukopenia
|
45.1%
46/102 • Number of events 235 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
10.8%
11/102 • Number of events 44 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
46.1%
47/102 • Number of events 263 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
23.5%
24/102 • Number of events 79 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Gastrointestinal disorders
Nausea
|
44.1%
45/102 • Number of events 110 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
31.4%
32/102 • Number of events 81 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
General disorders
Asthenia
|
14.7%
15/102 • Number of events 20 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
General disorders
Fatigue
|
7.8%
8/102 • Number of events 13 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
General disorders
Infusion site phlebitis
|
12.7%
13/102 • Number of events 18 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
General disorders
Pyrexia
|
23.5%
24/102 • Number of events 43 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
11/102 • Number of events 17 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
13.7%
14/102 • Number of events 21 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
9.8%
10/102 • Number of events 15 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Haemoglobin decreased
|
10.8%
11/102 • Number of events 35 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Lymphocyte count decreased
|
19.6%
20/102 • Number of events 69 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Neutrophil count decreased
|
46.1%
47/102 • Number of events 247 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Platelet count decreased
|
40.2%
41/102 • Number of events 136 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
Weight decreased
|
9.8%
10/102 • Number of events 12 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Investigations
White blood cell count decreased
|
53.9%
55/102 • Number of events 283 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
25.5%
26/102 • Number of events 62 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.8%
8/102 • Number of events 10 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
9/102 • Number of events 10 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
9.8%
10/102 • Number of events 15 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.7%
16/102 • Number of events 19 • From first administration of bendamustine through 30 days after the last administration (up to 2.5 Years)
Safety analysis set included all enrolled participants who were treated with any amount of study drug.
|
Additional Information
Director, Clinical Research
Teva Branded Pharmaceutical Products R&D, Inc.
Phone: 1-888-483-8279
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.
- Publication restrictions are in place
Restriction type: OTHER