Trial Outcomes & Findings for Maintenance Lenalidomide in Lymphoma (NCT NCT01575860)
NCT ID: NCT01575860
Last Updated: 2023-03-27
Results Overview
Dose-limiting toxicity (DLT) is defined as any grade 3 toxicity or higher that occurs during the first 28 days of therapy and is possibly, probably, or definitely related to lenalidomide maintenance.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
8 participants
Primary outcome timeframe
28 days (Cycle 1)
Results posted on
2023-03-27
Participant Flow
Participant milestones
| Measure |
Maintenance Lenalidomide in Lymphoma
Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
Maintenance Lenalidomide in Lymphoma
Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Progression Prior to Lenalidomide Maint.
|
1
|
Baseline Characteristics
Maintenance Lenalidomide in Lymphoma
Baseline characteristics by cohort
| Measure |
Maintenance Lenalidomide in Lymphoma
n=6 Participants
Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily.
|
|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 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
|
6 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
|
6 Participants
n=5 Participants
|
|
Lymphoma sub-type
Hodgkin Lymphoma
|
2 Participants
n=5 Participants
|
|
Lymphoma sub-type
Diffuse Large B-Cell, Activated B-Cell subtype
|
1 Participants
n=5 Participants
|
|
Lymphoma sub-type
Diffuse Large B-Cell, Germinal Center subtype
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 28 days (Cycle 1)Population: Eight (8) participants were enrolled: one (1) participant withdrew consent prior to completing Cycle 1; one (1) participant progressed prior to initiating lenalidomide maintenance; a total of six (6) subjects were evaluated for dose-limiting toxicities.
Dose-limiting toxicity (DLT) is defined as any grade 3 toxicity or higher that occurs during the first 28 days of therapy and is possibly, probably, or definitely related to lenalidomide maintenance.
Outcome measures
| Measure |
Maintenance Lenalidomide in Lymphoma
n=6 Participants
Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily
|
|---|---|
|
Number of Subjects With Dose-limiting Toxicities
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 months from start of lenalidomide maintenancePopulation: Eight (8) participants were enrolled: one (1) participant withdrew consent prior to completing Cycle 1; one (1) participant progressed prior to initiating lenalidomide maintenance; six (6) participants were evaluable.
Progression free survival (PFS) is defined as days from start of high dose chemotherapy to first documented progression of disease, death due to any cause or last patient contact.
Outcome measures
| Measure |
Maintenance Lenalidomide in Lymphoma
n=6 Participants
Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily
|
|---|---|
|
Progression Free Survival
Participants without Disease Progression
|
4 Participants
|
|
Progression Free Survival
Participants with Disease Progression
|
2 Participants
|
SECONDARY outcome
Timeframe: 12 months from the start of lenalidomide maintenancePopulation: Eight (8) participants were enrolled: one (1) participant withdrew consent prior to completing Cycle 1; one (1) participant progressed prior to initiating lenalidomide maintenance; six (6) participants were evaluable.
Overall survival (OS) is defined as days from start of high dose chemotherapy to death due to any cause or last patient contact.
Outcome measures
| Measure |
Maintenance Lenalidomide in Lymphoma
n=6 Participants
Total of twenty-four (24) 28-day cycles of Lenalidomide, 10mg, oral tablets, daily
|
|---|---|
|
Overall Survival
Participants Alive
|
4 Participants
|
|
Overall Survival
Participants Deceased
|
2 Participants
|
Adverse Events
Maintenance Lenalidomide in Lymphoma
Serious events: 0 serious events
Other events: 3 other events
Deaths: 2 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Maintenance Lenalidomide in Lymphoma
n=6 participants at risk
Total of twenty-four (24) 28-day cycles of lenalidomide, 10mg, oral tablets, daily
Lenalidomide: Lenalidomide, 10mg, oral tablets, daily
|
|---|---|
|
General disorders
Fatigue (Grade 1)
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
|
General disorders
Fatigue (Grade 2)
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Cough (Grade 2)
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
|
Gastrointestinal disorders
Diarrhea
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infection
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
|
Immune system disorders
Hypogammaglobunemia
|
16.7%
1/6 • Number of events 1 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
|
Investigations
White blood cell decreased
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
|
Investigations
Neutrophil count decreased
|
33.3%
2/6 • Number of events 2 • Adverse event data were collected from each subject's first dose of lenalidomide to twenty-eight days following each subject's last dose of lenalidomide, or upon resolution of any treatment-related adverse events, should their duration extend beyond the 28-day reporting period up to 28 days +/- 7 days after participant study discontinuation.
|
Additional Information
Jakub Svoboda, MD. Study Principal Investigator
Abramson Cancer Center of the University of Pennsylvania
Phone: 855-216-0098
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place