Trial Outcomes & Findings for Revlimid® as Consolidation Treatment Chronic Lymphocytic Leukemia (NCT NCT01600053)
NCT ID: NCT01600053
Last Updated: 2016-12-15
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
11 participants
Primary outcome timeframe
From date of first dose until then end of 12 cycles of treatment (12 months) or progression of disease, whichever comes first.
Results posted on
2016-12-15
Participant Flow
Participant milestones
| Measure |
Lenalidomide
Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.
|
|---|---|
|
Overall Study
STARTED
|
11
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Lenalidomide
Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
trial will not meet the interim endpoint
|
9
|
Baseline Characteristics
Revlimid® as Consolidation Treatment Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Lenalidomide
n=11 Participants
Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
|
Gender
Female
|
6 Participants
n=5 Participants
|
|
Gender
Male
|
5 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of first dose until then end of 12 cycles of treatment (12 months) or progression of disease, whichever comes first.Population: This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Data were not collected from the 11 participants before study termination.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From date of first dose until the date of first documented progression or date of death from any cause, whichever came firstPopulation: This study has been terminated. Interim analysis showed that the trial will not meet the interim endpoint. Please see adverse event listing for additional information.
Outcome measures
| Measure |
Lenalidomide
n=11 Participants
Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.
|
|---|---|
|
Recording of the Occurrence of Adverse Events
|
11 participants
|
Adverse Events
Lenalidomide
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lenalidomide
n=11 participants at risk
Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles
Lenalidomide: Lenalidomide will be taken orally days 1-21 for up to six 28-day cycles (6 cycles = 1 course of Revlimid consolidation). Revlimid will be initiated at 5mg and can be dose escalated at the start of each cycle based on individual patient tolerability to a maximum of 25 mg. The total number of treatment cycles cannot exceed 12 cycles or two courses of six cycles each.
|
|---|---|
|
General disorders
cough
|
54.5%
6/11 • Number of events 6
|
|
General disorders
non-cardiac chest pain
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
rash
|
45.5%
5/11 • Number of events 5
|
|
Skin and subcutaneous tissue disorders
pruritis
|
36.4%
4/11 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
throat pain
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
dysphagia
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
conjunctivitis
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
sinusiitis
|
18.2%
2/11 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
dry skin
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
diarrhea
|
63.6%
7/11 • Number of events 7
|
|
Nervous system disorders
headache
|
36.4%
4/11 • Number of events 4
|
|
General disorders
fever
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
neuropathy
|
36.4%
4/11 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
constipation
|
36.4%
4/11 • Number of events 4
|
|
Infections and infestations
URI
|
27.3%
3/11 • Number of events 3
|
|
Blood and lymphatic system disorders
neutropenia
|
81.8%
9/11 • Number of events 10
|
|
Metabolism and nutrition disorders
hypocalcemia
|
36.4%
4/11 • Number of events 4
|
|
Blood and lymphatic system disorders
anemia
|
27.3%
3/11 • Number of events 3
|
|
Metabolism and nutrition disorders
hyponatremia
|
54.5%
6/11 • Number of events 6
|
|
Metabolism and nutrition disorders
hypokalemia
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
hyperphosphatemia
|
18.2%
2/11 • Number of events 2
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
81.8%
9/11 • Number of events 9
|
|
General disorders
fatigue
|
45.5%
5/11 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
colitis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
rectal hemorrhage
|
9.1%
1/11 • Number of events 1
|
|
Infections and infestations
small intestine infection
|
9.1%
1/11 • Number of events 1
|
|
Metabolism and nutrition disorders
hypomagnesium
|
45.5%
5/11 • Number of events 5
|
|
Investigations
elevated AST
|
18.2%
2/11 • Number of events 2
|
|
Gastrointestinal disorders
nausea
|
18.2%
2/11 • Number of events 2
|
|
Eye disorders
eye pain
|
18.2%
2/11 • Number of events 2
|
|
Eye disorders
blurred vision
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
stomach pain
|
9.1%
1/11 • Number of events 1
|
|
Investigations
elevated ALT
|
54.5%
6/11 • Number of events 6
|
|
Metabolism and nutrition disorders
hypoalbuminemia
|
9.1%
1/11 • Number of events 1
|
|
Investigations
elevated creatine
|
9.1%
1/11 • Number of events 1
|
|
Investigations
weight loss
|
9.1%
1/11 • Number of events 1
|
|
Eye disorders
dry eyes
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
abdominal distension
|
9.1%
1/11 • Number of events 1
|
|
Vascular disorders
hypertension
|
9.1%
1/11 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
skin ulceration
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
muscle weakness
|
18.2%
2/11 • Number of events 2
|
|
Metabolism and nutrition disorders
hypophosphatemia
|
18.2%
2/11 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
18.2%
2/11 • Number of events 2
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
tumor pain
|
27.3%
3/11 • Number of events 3
|
|
Nervous system disorders
tremors
|
18.2%
2/11 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
hyperhidrosis
|
9.1%
1/11 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
18.2%
2/11 • Number of events 2
|
|
Renal and urinary disorders
urinary frequency
|
9.1%
1/11 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
allergic rhinitis
|
9.1%
1/11 • Number of events 1
|
|
Gastrointestinal disorders
dyspepsia
|
27.3%
3/11 • Number of events 3
|
|
Metabolism and nutrition disorders
hypercalcemia
|
9.1%
1/11 • Number of events 1
|
|
Nervous system disorders
dizziness
|
9.1%
1/11 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place