Trial Outcomes & Findings for Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia (NCT NCT01649791)
NCT ID: NCT01649791
Last Updated: 2016-06-30
Results Overview
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
8 participants
Primary outcome timeframe
24 months
Results posted on
2016-06-30
Participant Flow
Participant milestones
| Measure |
Treatment (Lenalidomide as Chemoprevention)
Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study
|
|---|---|
|
Overall Study
STARTED
|
8
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Treatment (Lenalidomide as Chemoprevention)
Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study
|
|---|---|
|
Overall Study
Disease Progression
|
2
|
|
Overall Study
Adverse Event
|
1
|
Baseline Characteristics
Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia
Baseline characteristics by cohort
| Measure |
Treatment (Lenalidomide as Chemoprevention)
n=8 Participants
Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study
|
|---|---|
|
Age, Continuous
|
63 years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 24 monthsPopulation: All treated and eligible patients.
Outcome measures
| Measure |
Treatment (Lenalidomide as Chemoprevention)
n=8 Participants
Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study
|
|---|---|
|
Median Progression-free Survival
|
43.7 months
Interval 7.6 to 43.7
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All treated and eligible patients.
Outcome measures
| Measure |
Treatment (Lenalidomide as Chemoprevention)
n=8 Participants
Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study
|
|---|---|
|
Overall Response Rate (CR+PR)
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: All treated and eligible patients.
Number of participants with Tumour flare.
Outcome measures
| Measure |
Treatment (Lenalidomide as Chemoprevention)
n=8 Participants
Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study
|
|---|---|
|
Incidence of Immune Mediated Flare Reaction
|
4 participants
|
SECONDARY outcome
Timeframe: 8 daysPopulation: No participants were analyzed.
PI left the institute and the data was not collected.
Outcome measures
Outcome data not reported
Adverse Events
Treatment (Lenalidomide as Chemoprevention)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Treatment (Lenalidomide as Chemoprevention)
n=8 participants at risk
Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
12.5%
1/8 • Number of events 1
|
Other adverse events
| Measure |
Treatment (Lenalidomide as Chemoprevention)
n=8 participants at risk
Patients receive lenalidomide PO once daily for 4 weeks. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
lenalidomide: Given orally
laboratory biomarker analysis: Correlative study
lymph node biopsy: Correlative study
bone marrow aspiration: Correlative study
pharmacological study: Correlative study
flow cytometry: Correlative study
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • Number of events 4
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.5%
1/8 • Number of events 1
|
|
Blood and lymphatic system disorders
Neutropenia
|
62.5%
5/8 • Number of events 19
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal distension
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
1/8 • Number of events 2
|
|
Gastrointestinal disorders
Constipation
|
25.0%
2/8 • Number of events 2
|
|
Gastrointestinal disorders
Diarrhoea
|
87.5%
7/8 • Number of events 9
|
|
Gastrointestinal disorders
Dry mouth
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Faeces hard
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Flatulence
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
1/8 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
12.5%
1/8 • Number of events 4
|
|
Gastrointestinal disorders
Vomiting
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Chills
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Fatigue
|
87.5%
7/8 • Number of events 8
|
|
General disorders
Injection site pain
|
12.5%
1/8 • Number of events 1
|
|
General disorders
Oedema
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Oedema peripheral
|
25.0%
2/8 • Number of events 2
|
|
General disorders
Pain
|
12.5%
1/8 • Number of events 2
|
|
General disorders
Pyrexia
|
12.5%
1/8 • Number of events 4
|
|
Immune system disorders
Hypersensitivity
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Cellulitis
|
12.5%
1/8 • Number of events 3
|
|
Infections and infestations
Ear infection
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Infection
|
25.0%
2/8 • Number of events 2
|
|
Infections and infestations
Pharyngitis
|
12.5%
1/8 • Number of events 1
|
|
Infections and infestations
Pneumonia
|
12.5%
1/8 • Number of events 2
|
|
Infections and infestations
Sinusitis
|
37.5%
3/8 • Number of events 3
|
|
Infections and infestations
Upper respiratory tract infection
|
62.5%
5/8 • Number of events 5
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
12.5%
1/8 • Number of events 1
|
|
Injury, poisoning and procedural complications
Skin laceration
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Alanine aminotransferase increased
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood phosphorus increased
|
25.0%
2/8 • Number of events 2
|
|
Investigations
Blood potassium decreased
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Blood potassium increased
|
12.5%
1/8 • Number of events 1
|
|
Investigations
Weight decreased
|
37.5%
3/8 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
12.5%
1/8 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
12.5%
1/8 • Number of events 4
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.5%
1/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
12.5%
1/8 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
50.0%
4/8 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8 • Number of events 1
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour flare
|
50.0%
4/8 • Number of events 8
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Headache
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Hypoaesthesia
|
25.0%
2/8 • Number of events 3
|
|
Nervous system disorders
Hypogeusia
|
37.5%
3/8 • Number of events 4
|
|
Nervous system disorders
Lethargy
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Paraesthesia
|
12.5%
1/8 • Number of events 1
|
|
Nervous system disorders
Tremor
|
12.5%
1/8 • Number of events 2
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • Number of events 1
|
|
Psychiatric disorders
Libido decreased
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
37.5%
3/8 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
50.0%
4/8 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
25.0%
2/8 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
50.0%
4/8 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
12.5%
1/8 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
12.5%
1/8 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
25.0%
2/8 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
2/8 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Rash
|
62.5%
5/8 • Number of events 11
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
12.5%
1/8 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
12.5%
1/8 • Number of events 1
|
|
Surgical and medical procedures
Tooth extraction
|
12.5%
1/8 • Number of events 1
|
|
Vascular disorders
Hot flush
|
12.5%
1/8 • Number of events 1
|
Additional Information
Senior Administrator, Compliance - Clinical Research Services
Roswell Park Cancer Institute
Phone: 716-845-2300
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place