Trial Outcomes & Findings for Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL (NCT NCT00974233)
NCT ID: NCT00974233
Last Updated: 2019-12-02
Results Overview
The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
34 participants
Primary outcome timeframe
42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)
Results posted on
2019-12-02
Participant Flow
Research subjected from the University of Wisconsin and 7 Wisconsin Oncology Network institutions were enrolled from October 2009 to November 2011. Subjects were enrolled from outpatient hematology clinics at each participating institution.
Participant milestones
| Measure |
Induction Chemoimmunotherapy + Maintenance Lenalidomide
Induction therapy: Bendamustine 90 mg/m2 IV on days 1 \& 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles. Maintenance therapy: Lenalidomide 5-10 mg orally continuously of each 28-day cycles for total of 12 treatment cycles.
|
|---|---|
|
Induction Chemoimmunotherapy
STARTED
|
34
|
|
Induction Chemoimmunotherapy
COMPLETED
|
19
|
|
Induction Chemoimmunotherapy
NOT COMPLETED
|
15
|
|
Maintenance Lenalidomide
STARTED
|
19
|
|
Maintenance Lenalidomide
COMPLETED
|
6
|
|
Maintenance Lenalidomide
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Induction Chemoimmunotherapy + Maintenance Lenalidomide
Induction therapy: Bendamustine 90 mg/m2 IV on days 1 \& 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles. Maintenance therapy: Lenalidomide 5-10 mg orally continuously of each 28-day cycles for total of 12 treatment cycles.
|
|---|---|
|
Induction Chemoimmunotherapy
Death
|
2
|
|
Induction Chemoimmunotherapy
Lack of Efficacy
|
5
|
|
Induction Chemoimmunotherapy
Adverse Event
|
7
|
|
Induction Chemoimmunotherapy
Withdrawal by Subject
|
1
|
|
Maintenance Lenalidomide
Lack of Efficacy
|
5
|
|
Maintenance Lenalidomide
Adverse Event
|
8
|
Baseline Characteristics
Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL
Baseline characteristics by cohort
| Measure |
Overall Study Population
n=34 Participants
Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen).
|
|---|---|
|
Age, Continuous
|
67 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
24 Participants
n=5 Participants
|
|
ECOG performance status
ECOG performance status 0-1
|
32 participants
n=5 Participants
|
|
ECOG performance status
ECOG performance status 2
|
2 participants
n=5 Participants
|
|
Disease staging
Rai stage 1/2 (CLL)
|
12 participants
n=5 Participants
|
|
Disease staging
Rai stage 3/4 (CLL)
|
14 participants
n=5 Participants
|
|
Disease staging
Ann Arbor stage 1/2 (SLL)
|
1 participants
n=5 Participants
|
|
Disease staging
Ann Arbor 3/4 (SLL)
|
7 participants
n=5 Participants
|
|
Median prior therapies
|
2 prior therapies
n=5 Participants
|
|
Prior therapy with fludarabine
Prior fludarabine-based therapy
|
23 participants
n=5 Participants
|
|
Prior therapy with fludarabine
No previous fludrarabine exposure
|
11 participants
n=5 Participants
|
|
Refractory to most recent therapy
Refractory to most recent therapy
|
4 participants
n=5 Participants
|
|
Refractory to most recent therapy
Not refractory to most recent therapy
|
30 participants
n=5 Participants
|
|
Elevated serum lactate dehydrogenase (LDH) level
Enrollment LDH elevated
|
20 participants
n=5 Participants
|
|
Elevated serum lactate dehydrogenase (LDH) level
Enrollment LDH not elevated
|
14 participants
n=5 Participants
|
|
Baseline cytogenetics
17p or 11q deletions
|
11 participants
n=5 Participants
|
|
Baseline cytogenetics
13q deletion
|
2 participants
n=5 Participants
|
|
Baseline cytogenetics
Trisomy 12
|
8 participants
n=5 Participants
|
|
Baseline cytogenetics
Normal
|
3 participants
n=5 Participants
|
|
Baseline cytogenetics
Unknown
|
10 participants
n=5 Participants
|
|
Prior therapy with rituximab
Prior therapy with rituximab
|
27 participants
n=5 Participants
|
|
Prior therapy with rituximab
No prior therapy with rituximab
|
7 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)Population: The study was designed to test the null hypothesis that the median PFS with induction BR and maintenance lenalidomide is at most 18 months versus the alternative hypothesis that median PFS is \>18 months, at a one-sided significance level of 0.10 with a power of 80%.
The primary endpoint of this study was progression-free survival (PFS), defined as the number of days from the day of first study drug administration to the day the patient experienced disease progression or death from any cause. Response and progression in cases of small lymphocytic lymphoma(SLL) were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of chronic lymphocytic leukemia (CLL) were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007).
Outcome measures
| Measure |
Induction/Maintenance Chemotherapy
n=34 Participants
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
|
Partial Response (PR)
Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count.
|
Stable Disease
Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response.
|
Overall Response Rate
Includes complete and partial responses.
|
|---|---|---|---|---|
|
Progression Free Survival
|
18.3 months
Interval 10.6 to 24.3
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)Progression-free survival (PFS) is defined as the time from the day of first study drug administration until progression of CLL/SLL or death from any cause. PFS is reported as the proportion of participants with PFS up to 42 months.
Outcome measures
| Measure |
Induction/Maintenance Chemotherapy
n=34 Participants
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
|
Partial Response (PR)
Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count.
|
Stable Disease
Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response.
|
Overall Response Rate
Includes complete and partial responses.
|
|---|---|---|---|---|
|
Progression-free Survival
1-year progression-free survival
|
0.62 Proportion of participants
Interval 0.47 to 0.8
|
—
|
—
|
—
|
|
Progression-free Survival
2-year progression-free survival
|
0.35 Proportion of participants
Interval 0.22 to 0.56
|
—
|
—
|
—
|
|
Progression-free Survival
3-year progression-free survival
|
0.23 Proportion of participants
Interval 0.12 to 0.43
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)Response and progression in cases of SLL were evaluated using the International Working Group Criteria for response in NHL (Cheson, et al 1996). Response and progression in cases of CLL were evaluated using the NCI-sponsored CLL Working Group guidelines for CLL (Cheson, et al 2007). Complete response defined as resolution enlarged lymph nodes, spleen and liver; normalization of blood counts (neutrophils, hemoglobin, platelets); no residual CLL/SLL detectable in the bone marrow. Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count. Progressive disease defined as 50% or more increase in the combined measurements of at least 2 lymph nodes as measured on CT scans or the appearance of new enlarged lymph nodes; 50% of more increase in the size of the spleen or liver; 50% or more increase in blood lymphocyte count.
Outcome measures
| Measure |
Induction/Maintenance Chemotherapy
n=34 Participants
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
|
Partial Response (PR)
n=34 Participants
Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count.
|
Stable Disease
n=34 Participants
Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response.
|
Overall Response Rate
n=34 Participants
Includes complete and partial responses.
|
|---|---|---|---|---|
|
Objective Response Rate (Complete + Partial Responses)
|
7 participants
|
12 participants
|
9 participants
|
19 participants
|
SECONDARY outcome
Timeframe: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)Population: Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.
Toxicities were reported using the Common Terminology Criteria for Adverse Events, version 3.0.
Outcome measures
| Measure |
Induction/Maintenance Chemotherapy
n=34 Participants
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
|
Partial Response (PR)
n=19 Participants
Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count.
|
Stable Disease
Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response.
|
Overall Response Rate
Includes complete and partial responses.
|
|---|---|---|---|---|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 leukopenia
|
5 participants
|
6 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 4 leukopenia
|
5 participants
|
1 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 neutropenia
|
6 participants
|
7 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 4 neutropenia
|
14 participants
|
2 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 anemia
|
1 participants
|
0 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 thrombocytopenia
|
5 participants
|
1 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 4 thrombocytopenia
|
2 participants
|
0 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 febrile neutropenia
|
4 participants
|
1 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 infection
|
10 participants
|
4 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 4 infection
|
1 participants
|
1 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 5 infection
|
1 participants
|
0 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 fatigue
|
2 participants
|
0 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 4 fatigue
|
0 participants
|
1 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 nausea/emesis
|
3 participants
|
0 participants
|
—
|
—
|
|
Toxicities Observed With Induction Chemotherapy and Maintenance Therapy
Grade 3 serum transaminase levels (Gr 3/Gr 4)
|
4 participants
|
0 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up)Population: Overall survival (OS) was measured for all enrolled subjects as the time from the day of first study drug administration until death from any cause.
Overall survival (OS) is defined as the time from the day of first study drug administration until death from any cause.
Outcome measures
| Measure |
Induction/Maintenance Chemotherapy
n=34 Participants
Bendamustine + rituximab induction therapy followed by lenalidomide maintenance therapy
Bendamustine: 90 mg/m2/day IV days 1 and 2 every 28 days for 6 cycles
Rituximab: 375 mg/m2 Day 1 every 28 days for 6 cycles
Lenalidomide: 5 mg/day days 1-28 of each 28 day cycle, up to 12 cycles maximum. Dose escalation to 10 mg/day allowed after one cycle as defined in the protocol.
|
Partial Response (PR)
Partial response defined as 50% or more reduction in size of enlarged lymph nodes, liver or spleen; 50% or more improvement of blood counts; 50% or more improvement in the blood lymphocyte count.
|
Stable Disease
Stable disease includes cases where there has been objective improvement in blood counts and lymph node size, but does not meet criteria for either a complete or partial response.
|
Overall Response Rate
Includes complete and partial responses.
|
|---|---|---|---|---|
|
Overall Survival
|
42.8 months
Interval 33.7 to 69.5
|
—
|
—
|
—
|
Adverse Events
Induction Chemoimmunotherapy
Serious events: 14 serious events
Other events: 34 other events
Deaths: 0 deaths
Maintenance
Serious events: 8 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Induction Chemoimmunotherapy
n=34 participants at risk
Bendamustine 90 mg/m2 IV on days 1 \& 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles.
|
Maintenance
n=19 participants at risk
Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment.
|
|---|---|---|
|
Blood and lymphatic system disorders
Grade 4 neutropenia
|
41.2%
14/34 • Number of events 14 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
10.5%
2/19 • Number of events 2 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Blood and lymphatic system disorders
Grade 3 neutropenia
|
17.6%
6/34 • Number of events 6 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
36.8%
7/19 • Number of events 7 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Blood and lymphatic system disorders
Grade 4 thrombocytopenia
|
5.9%
2/34 • Number of events 2 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Blood and lymphatic system disorders
Grade 3 thrombocytopenia
|
14.7%
5/34 • Number of events 5 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
5.3%
1/19 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Blood and lymphatic system disorders
Grade 4 leukopenia
|
14.7%
5/34 • Number of events 5 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
5.3%
1/19 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Blood and lymphatic system disorders
Grade 3 leukopenia
|
14.7%
5/34 • Number of events 5 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
31.6%
6/19 • Number of events 6 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Infections and infestations
Grade 4 febrile neutropenia
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Infections and infestations
Grade 3 febrile neutropenia
|
11.8%
4/34 • Number of events 4 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
5.3%
1/19 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Infections and infestations
Grade 5 infections
|
2.9%
1/34 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Infections and infestations
Grade 4 infections
|
2.9%
1/34 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
5.3%
1/19 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Metabolism and nutrition disorders
Grade 3 tumor lysis syndrome
|
2.9%
1/34 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Blood and lymphatic system disorders
Grade 3 thrombosis
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
5.3%
1/19 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Second primary malignancy
|
2.9%
1/34 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
5.3%
1/19 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Cardiac disorders
Grade 3 prolonged QTc interval
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
5.3%
1/19 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Cardiac disorders
Grade 5 heart failure
|
2.9%
1/34 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
Other adverse events
| Measure |
Induction Chemoimmunotherapy
n=34 participants at risk
Bendamustine 90 mg/m2 IV on days 1 \& 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles.
|
Maintenance
n=19 participants at risk
Lenalidomide 5-10 mg administered orally daily as continuous therapy for up to 12 treatment cycles (28-day treatment cycles) in patients without disease progression or treatment-related toxicities that would prohibit ongoing treatment.
|
|---|---|---|
|
Infections and infestations
Grade 3 Infections
|
29.4%
10/34 • Number of events 10 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
21.1%
4/19 • Number of events 4 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
General disorders
Grade 3 fatigue
|
5.9%
2/34 • Number of events 2 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
General disorders
Grade 1-2 fatigue
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
31.6%
6/19 • Number of events 6 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Gastrointestinal disorders
Grade 3 emesis
|
5.9%
2/34 • Number of events 2 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Gastrointestinal disorders
Grade 1-2 nausea
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
21.1%
4/19 • Number of events 4 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Gastrointestinal disorders
Grade 3 diarrhea
|
8.8%
3/34 • Number of events 3 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Metabolism and nutrition disorders
Grade 3 hypophosphatemia
|
5.9%
2/34 • Number of events 2 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Hepatobiliary disorders
Grade 3 elevated AST/ALT
|
11.8%
4/34 • Number of events 4 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Hepatobiliary disorders
Grade 1-2 AST/ALT
|
11.8%
4/34 • Number of events 4 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
General disorders
Grade 1-2 night sweats
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
15.8%
3/19 • Number of events 3 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Skin and subcutaneous tissue disorders
Grade 1-2 rash
|
14.7%
5/34 • Number of events 5 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
26.3%
5/19 • Number of events 5 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Respiratory, thoracic and mediastinal disorders
Grade 1-2 cough
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
21.1%
4/19 • Number of events 4 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Nervous system disorders
Grade 1-2 headache
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
15.8%
3/19 • Number of events 3 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Grade 1-2 musculoskeletal pain
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
31.6%
6/19 • Number of events 6 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Musculoskeletal and connective tissue disorders
Grade 3 pain NOS
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
10.5%
2/19 • Number of events 2 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Metabolism and nutrition disorders
Grade 1-2 hyperglycemia
|
0.00%
0/34 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
21.1%
4/19 • Number of events 4 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Gastrointestinal disorders
Grade 1-2 emesis
|
5.9%
2/34 • Number of events 2 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
5.3%
1/19 • Number of events 1 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
|
Gastrointestinal disorders
Grade 2 stomatitis
|
5.9%
2/34 • Number of events 2 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
0.00%
0/19 • Adverse event date was captured from the time of study enrollment until at least 30 days following the final dose of study treatment.
Any serious or unexpected adverse event was reported during the entire duration of long-term follow-up.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place