Trial Outcomes & Findings for Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma (NCT NCT04155840)
NCT ID: NCT04155840
Last Updated: 2022-04-11
Results Overview
Will use a Simon optimal two-stage design.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
1 participants
Primary outcome timeframe
End of cycle 4 (each cycle is 28 days)
Results posted on
2022-04-11
Participant Flow
Participant milestones
| Measure |
Treatment (Copanlisib, Rituximab, Bendamustine)
Patients receive copanlisib IV over 1 hour on days 1, 8 and 15 or days 1 and 15 (depending on dose level). Patients also receive rituximab IV on day 1 and bendamustine IV on days 1 and 2 of cycles 1-4. Patients who achieve at least a partial response (MRD-positive) continue on treatment for 2 additional cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients receive copanlisib IV over 1 hour on days 1 and 15 for an additional 6 cycles in the absence of disease progression or unacceptable toxicity.
Copanlisib: Given IV
Rituximab: Given IV
Bendamustine: Given IV
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bendamustine and Rituximab in Combination With Copanlisib for the Treatment of Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma
Baseline characteristics by cohort
| Measure |
Treatment (Copanlisib, Rituximab, Bendamustine)
n=1 Participants
Patients receive copanlisib IV over 1 hour on days 1, 8 and 15 or days 1 and 15 (depending on dose level). Patients also receive rituximab IV on day 1 and bendamustine IV on days 1 and 2 of cycles 1-4. Patients who achieve at least a partial response (MRD-positive) continue on treatment for 2 additional cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients receive copanlisib IV over 1 hour on days 1 and 15 for an additional 6 cycles in the absence of disease progression or unacceptable toxicity.
Copanlisib: Given IV
Rituximab: Given IV
Bendamustine: Given IV
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
72 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 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
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
1 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
|
1 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: End of cycle 4 (each cycle is 28 days)Population: Data for the outcome measure was collected, however, the outcome measure was not analyzed because we were unable to determine the marrow minimal residual disease (MRD)-negative rate due to low accrual and few data timepoints for which meaningful data could be extracted.
Will use a Simon optimal two-stage design.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 yearPopulation: Data for the outcome measure was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At 1 and 3 yearsPopulation: Data for the outcome measure was not collected.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: End of cycle 4 (each cycle is 28 days)Population: This outcome measure was not done. The MRD sample after Cycle 4 was received at the analyzing lab beyond stability.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 6 monthsPopulation: Data for the outcome measure was collected, however, the outcome measure was not analyzed due to low accrual and few data timepoints for which meaningful data could be extracted.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Copanlisib, Rituximab, Bendamustine)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment (Copanlisib, Rituximab, Bendamustine)
n=1 participants at risk
Patients receive copanlisib IV over 1 hour on days 1, 8 and 15 or days 1 and 15 (depending on dose level). Patients also receive rituximab IV on day 1 and bendamustine IV on days 1 and 2 of cycles 1-4. Patients who achieve at least a partial response (MRD-positive) continue on treatment for 2 additional cycles. Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Beginning cycle 7, patients receive copanlisib IV over 1 hour on days 1 and 15 for an additional 6 cycles in the absence of disease progression or unacceptable toxicity.
Copanlisib: Given IV
Rituximab: Given IV
Bendamustine: Given IV
|
|---|---|
|
Metabolism and nutrition disorders
Anorexia
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
General disorders
Chills
|
100.0%
1/1 • Number of events 2 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Nervous system disorders
Dizziness
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Gastrointestinal disorders
Dyspepsia
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
General disorders
Fever
|
100.0%
1/1 • Number of events 2 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Gastrointestinal disorders
Flatulance
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
General disorders
Knots on forehead
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
General disorders
Bilateral nipple pain
|
100.0%
1/1 • Number of events 2 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Reproductive system and breast disorders
Gynecomastia
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Injury, poisoning and procedural complications
Infusion-related reaction
|
100.0%
1/1 • Number of events 5 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
General disorders
Bilateral ankle edema
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Gastrointestinal disorders
Nausea
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Investigations
Neutrophil count decreased
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
General disorders
Clammy feeling
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Investigations
Platelet count decreased
|
100.0%
1/1 • Number of events 2 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Skin and subcutaneous tissue disorders
Rash
|
100.0%
1/1 • Number of events 3 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Skin and subcutaneous tissue disorders
Papule on back
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Skin and subcutaneous tissue disorders
Flaking lesion, right cheek
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
|
|
Metabolism and nutrition disorders
Tumor lysis syndrome
|
100.0%
1/1 • Number of events 1 • Adverse events are collected after the first administration of copanlisib until the end of treatment visit, approximately 6 months.
Adverse events are collected through regular investigator assessment, regular laboratory testing, and patient interviews.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place