Trial Outcomes & Findings for Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma (NCT NCT00695786)
NCT ID: NCT00695786
Last Updated: 2021-10-20
Results Overview
Will be monitored simultaneously for each of the subgroups separately using the Bayesian approach of Thall, Simon, Estey. Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. Logistic regression will be will be utilized to assess the effect of patient prognostic factors on the response rate.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
156 participants
Primary outcome timeframe
At the end of 3 courses (84 days)
Results posted on
2021-10-20
Participant Flow
Recruitment period from time of protocol activation 06/10/2008 to protocol closure to new patient entry 02/04/2013.
156 patients were enrolled to participant: 2 patients were deemed histologically ineligible, 79 patients had follicular lymphoma, 31 patients had marginal zone lymphoma, and 44 patients had small lymphocytic lymphoma.
Participant milestones
| Measure |
Other Histology
Other Histology
|
Follicular Lymphoma
Follicular Lymphoma
|
Marginal Zone Lymphoma
Marginal Zone Lymphoma
|
Small Lymphocytic Lymphoma
Small Lymphocytic Lymphoma
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
79
|
31
|
44
|
|
Overall Study
COMPLETED
|
1
|
67
|
23
|
36
|
|
Overall Study
NOT COMPLETED
|
1
|
12
|
8
|
8
|
Reasons for withdrawal
| Measure |
Other Histology
Other Histology
|
Follicular Lymphoma
Follicular Lymphoma
|
Marginal Zone Lymphoma
Marginal Zone Lymphoma
|
Small Lymphocytic Lymphoma
Small Lymphocytic Lymphoma
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
3
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
0
|
5
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
4
|
3
|
1
|
|
Overall Study
Deemed Ineligible
|
1
|
0
|
0
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
0
|
0
|
4
|
Baseline Characteristics
Lenalidomide in Combination With Rituximab in Treating Participants With Stage III/IV Indolent Non-Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Other Histology
n=2 Participants
Other Histology
|
Follicular Lymphoma
n=79 Participants
Follicular Lymphoma
|
Marginal Zone Lymphoma
n=31 Participants
Marginal Zone Lymphoma
|
Small Lymphocytic Lymphoma
n=44 Participants
Small Lymphocytic Lymphoma
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
123 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
75 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
81 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
106 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
72 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
132 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
2 participants
n=5 Participants
|
77 participants
n=7 Participants
|
31 participants
n=5 Participants
|
44 participants
n=4 Participants
|
154 participants
n=21 Participants
|
|
Region of Enrollment
United Arab Emirates
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
2 participants
n=21 Participants
|
|
Lymphoma - Non-Hodgkin Stages
Stage I
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Lymphoma - Non-Hodgkin Stages
Stage III
|
0 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
46 Participants
n=21 Participants
|
|
Lymphoma - Non-Hodgkin Stages
Stage IV
|
2 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
42 Participants
n=4 Participants
|
109 Participants
n=21 Participants
|
|
Bone Marrow Involvement (+)
|
2 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
48 Participants
n=21 Participants
|
|
Splenomegaly (+)
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Participants with B Symptoms (+)
|
1 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: At the end of 3 courses (84 days)Will be monitored simultaneously for each of the subgroups separately using the Bayesian approach of Thall, Simon, Estey. Summary statistics will be provided for continuous variables. Frequency tables will be used to summarize categorical variables. Logistic regression will be will be utilized to assess the effect of patient prognostic factors on the response rate.
Outcome measures
| Measure |
Other Histology
n=2 Participants
Other Histology
|
Follicular Lymphoma
n=79 Participants
Follicular Lymphoma
|
Marginal Zone Lymphoma
n=31 Participants
Marginal Zone Lymphoma
|
Small Lymphocytic Lymphoma
n=44 Participants
Small Lymphocytic Lymphoma
|
|---|---|---|---|---|
|
Number of Participants With Best Overall Disease Response
Best Overall Response - CR
|
0 Participants
|
56 Participants
|
17 Participants
|
8 Participants
|
|
Number of Participants With Best Overall Disease Response
Best Overall Response - CRu Response
|
0 Participants
|
13 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants With Best Overall Disease Response
Best Overall Response - PR
|
1 Participants
|
6 Participants
|
4 Participants
|
21 Participants
|
|
Number of Participants With Best Overall Disease Response
Best Overall Response - SD
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants With Best Overall Disease Response
Best Overall Response - PD
|
0 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Best Overall Disease Response
Best Overall Response - Inevaluable
|
1 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
Adverse Events
Other Histology
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Follicular Lymphoma
Serious events: 8 serious events
Other events: 0 other events
Deaths: 0 deaths
Marginal Zone Lymphoma
Serious events: 4 serious events
Other events: 0 other events
Deaths: 0 deaths
Small Lymphocytic Lymphoma
Serious events: 12 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Other Histology
n=2 participants at risk
Other Histology
|
Follicular Lymphoma
n=79 participants at risk
Follicular Lymphoma
|
Marginal Zone Lymphoma
n=31 participants at risk
Marginal Zone Lymphoma
|
Small Lymphocytic Lymphoma
n=44 participants at risk
Small Lymphocytic Lymphoma
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.3%
1/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
General disorders
Cytokine Release
|
50.0%
1/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
1.3%
1/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
3.2%
1/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Cardiac disorders
Cardiac General (Other)
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.5%
2/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
4.5%
2/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Nervous system disorders
Dizziness
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
1.3%
1/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.3%
1/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.3%
1/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Infections and infestations
Infection
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.3%
1/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Nervous system disorders
Ischemia cardiovascular
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.3%
1/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Nervous system disorders
Memory Loss
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.3%
1/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
General disorders
Pain
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
3.2%
1/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
1.3%
1/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
3.2%
1/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary (Other)
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.5%
2/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
2.3%
1/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Secondary Malignancy
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
10.1%
8/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
3.2%
1/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
|
Vascular disorders
Thrombosis
|
0.00%
0/2 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
1.3%
1/79 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
0.00%
0/31 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
6.8%
3/44 • beginning at the start of intervention and through 30 days post intervention completion, up to 366 days
|
Other adverse events
Adverse event data not reported
Additional Information
Felipe Samaniego,MD/Professor, Lymphoma-Myeloma
UT MD Anderson Cancer Center
Phone: (713) 745-6824
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place