Trial Outcomes & Findings for Phase II Protocol for CLL With Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide (NCT NCT01723839)
NCT ID: NCT01723839
Last Updated: 2022-10-10
Results Overview
Analysis of the Primary Endpoint: The complete responses will be estimated by the number of patients with CR divided by the total number of evaluable patients.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
21 participants
Primary outcome timeframe
28 day cycle, up to 4 cycles
Results posted on
2022-10-10
Participant Flow
Participant milestones
| Measure |
FCR With Lenalidomide
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide - 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity. If there are at least 5 CRs after 4 cycles of FCR plus lenalidomide the study will accrue an additional 35 subjects.
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide: 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity.
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
12
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase II Protocol for CLL With Fludarabine and Cyclophosphamide With Rituximab (FCR) Plus Lenalidomide
Baseline characteristics by cohort
| Measure |
FCR With Lenalidomide
n=21 Participants
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide - 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity. If there are at least 5 CRs after 4 cycles of FCR plus lenalidomide the study will accrue an additional 35 subjects.
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide: 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity.
|
|---|---|
|
Age, Continuous
|
62.5 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 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
|
2 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
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 day cycle, up to 4 cyclesPopulation: Of the 21 were enrolled, 20 were eligible for response evaluation.
Analysis of the Primary Endpoint: The complete responses will be estimated by the number of patients with CR divided by the total number of evaluable patients.
Outcome measures
| Measure |
FCR With Lenalidomide
n=20 Participants
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide - 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity. If there are at least 5 CRs after 4 cycles of FCR plus lenalidomide the study will accrue an additional 35 subjects.
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide: 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity.
|
|---|---|
|
Complete Response
|
45 Percentage of Participants
|
SECONDARY outcome
Timeframe: 28 day cycle, up to 6 cyclesPopulation: Of the 21 were enrolled, 20 were eligible for response evaluation.
Analysis of the other Secondary Endpoints: The overall response rate will be estimated by the number of patients with complete and partial responses divided by the total number of evaluable patients.
Outcome measures
| Measure |
FCR With Lenalidomide
n=20 Participants
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide - 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity. If there are at least 5 CRs after 4 cycles of FCR plus lenalidomide the study will accrue an additional 35 subjects.
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide: 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity.
|
|---|---|
|
Overall Response Rate
|
95 Percentage of Participants
|
Adverse Events
FCR With Lenalidomide
Serious events: 9 serious events
Other events: 19 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
FCR With Lenalidomide
n=21 participants at risk
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide - 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity. If there are at least 5 CRs after 4 cycles of FCR plus lenalidomide the study will accrue an additional 35 subjects.
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide: 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity.
|
|---|---|
|
Skin and subcutaneous tissue disorders
Maculopapular Rash
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
General disorders
Fever
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
Blood and lymphatic system disorders
Neutropenic Fever
|
14.3%
3/21 • Number of events 3 • From study enrollment to end of treatment, up to 18 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
Nervous system disorders
Seizure
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Infection
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
General disorders
Bilateral Leg Weakness
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
Other adverse events
| Measure |
FCR With Lenalidomide
n=21 participants at risk
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide - 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity. If there are at least 5 CRs after 4 cycles of FCR plus lenalidomide the study will accrue an additional 35 subjects.
Fludarabine, Cyclophosphamide, Rituximab, Lenalidomide: 19 subjects are treated in stage-1 with FCR plus 5mg lenalidomide increasing to 10mg and 15mg in subsequent cycles depending on toxicity.
|
|---|---|
|
Blood and lymphatic system disorders
Leukopenia
|
61.9%
13/21 • Number of events 13 • From study enrollment to end of treatment, up to 18 months
|
|
Blood and lymphatic system disorders
Anemia
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
90.5%
19/21 • Number of events 33 • From study enrollment to end of treatment, up to 18 months
|
|
Blood and lymphatic system disorders
Hyperglycemia
|
14.3%
3/21 • Number of events 3 • From study enrollment to end of treatment, up to 18 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
Blood and lymphatic system disorders
Infusion Reaction
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
Infections and infestations
Bacteremia
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
|
Skin and subcutaneous tissue disorders
Pustular Rash
|
4.8%
1/21 • Number of events 1 • From study enrollment to end of treatment, up to 18 months
|
Additional Information
Joshua Zenreich
John Theurer Cancer Center at Hackensack Meridian Health
Phone: 551-996-4248
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place