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Trial record 59 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide as Chemoprevention in Treating Patients With High-Risk, Early-Stage B-Cell Chronic Lymphocytic Leukemia

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ClinicalTrials.gov Identifier: NCT01649791
Recruitment Status : Terminated
First Posted : July 25, 2012
Results First Posted : February 27, 2014
Last Update Posted : June 30, 2016
Sponsor:
Collaborators:
National Cancer Institute (NCI)
Celgene Corporation
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions B-cell Chronic Lymphocytic Leukemia
Chronic Lymphocytic Leukemia
Stage 0 Chronic Lymphocytic Leukemia
Stage I Chronic Lymphocytic Leukemia
Stage II Chronic Lymphocytic Leukemia
Interventions Drug: lenalidomide
Other: laboratory biomarker analysis
Procedure: lymph node biopsy
Procedure: bone marrow aspiration
Other: pharmacological study
Other: flow cytometry
Enrollment 8
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Treatment (Lenalidomide as Chemoprevention)
Hide Arm/Group Description

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

Period Title: Overall Study
Started 8
Completed 5
Not Completed 3
Reason Not Completed
Disease Progression             2
Adverse Event             1
Arm/Group Title Treatment (Lenalidomide as Chemoprevention)
Hide Arm/Group Description

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 Number of Baseline Participants 8
Hide Baseline Analysis Population Description
All treated and eligible patients.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 8 participants
63  (8.8)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
<=18 years
0
   0.0%
Between 18 and 65 years
3
  37.5%
>=65 years
5
  62.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 8 participants
Female
1
  12.5%
Male
7
  87.5%
1.Primary Outcome
Title Median Progression-free Survival
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients.
Arm/Group Title Treatment (Lenalidomide as Chemoprevention)
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Median (95% Confidence Interval)
Unit of Measure: months
43.7
(7.6 to 43.7)
2.Secondary Outcome
Title Overall Response Rate (CR+PR)
Hide Description [Not Specified]
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients.
Arm/Group Title Treatment (Lenalidomide as Chemoprevention)
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: percentage of participants
100
3.Secondary Outcome
Title Incidence of Immune Mediated Flare Reaction
Hide Description Number of participants with Tumour flare.
Time Frame 24 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated and eligible patients.
Arm/Group Title Treatment (Lenalidomide as Chemoprevention)
Hide Arm/Group Description:

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 Number of Participants Analyzed 8
Measure Type: Number
Unit of Measure: participants
4
4.Secondary Outcome
Title Expression of B-CLL Co-stimulatory Ligands, Mic-A, and Mic-B Assessed by Flow Cytometry
Hide Description PI left the institute and the data was not collected.
Time Frame 8 days
Hide Outcome Measure Data
Hide Analysis Population Description
No participants were analyzed.
Arm/Group Title Treatment (Lenalidomide as Chemoprevention)
Hide Arm/Group Description:

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 Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Treatment (Lenalidomide as Chemoprevention)
Hide Arm/Group Description

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

All-Cause Mortality
Treatment (Lenalidomide as Chemoprevention)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Treatment (Lenalidomide as Chemoprevention)
Affected / at Risk (%) # Events
Total   2/8 (25.00%)    
Musculoskeletal and connective tissue disorders   
Muscular weakness   1/8 (12.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Basal cell carcinoma   1/8 (12.50%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Treatment (Lenalidomide as Chemoprevention)
Affected / at Risk (%) # Events
Total   8/8 (100.00%)    
Blood and lymphatic system disorders   
Anaemia   1/8 (12.50%)  4
Lymphadenopathy   1/8 (12.50%)  1
Neutropenia   5/8 (62.50%)  19
Thrombocytopenia   1/8 (12.50%)  1
Gastrointestinal disorders   
Abdominal distension   1/8 (12.50%)  1
Abdominal pain   1/8 (12.50%)  2
Constipation   2/8 (25.00%)  2
Diarrhoea   7/8 (87.50%)  9
Dry mouth   1/8 (12.50%)  1
Dyspepsia   1/8 (12.50%)  1
Faeces hard   1/8 (12.50%)  1
Flatulence   1/8 (12.50%)  1
Gastrooesophageal reflux disease   1/8 (12.50%)  1
Nausea   1/8 (12.50%)  4
Vomiting   1/8 (12.50%)  1
General disorders   
Chills   1/8 (12.50%)  1
Fatigue   7/8 (87.50%)  8
Injection site pain   1/8 (12.50%)  1
Oedema   2/8 (25.00%)  2
Oedema peripheral   2/8 (25.00%)  2
Pain   1/8 (12.50%)  2
Pyrexia   1/8 (12.50%)  4
Immune system disorders   
Hypersensitivity   1/8 (12.50%)  1
Infections and infestations   
Cellulitis   1/8 (12.50%)  3
Ear infection   1/8 (12.50%)  1
Infection   2/8 (25.00%)  2
Pharyngitis   1/8 (12.50%)  1
Pneumonia   1/8 (12.50%)  2
Sinusitis   3/8 (37.50%)  3
Upper respiratory tract infection   5/8 (62.50%)  5
Vulvovaginal mycotic infection   1/8 (12.50%)  1
Injury, poisoning and procedural complications   
Skin laceration   1/8 (12.50%)  1
Investigations   
Alanine aminotransferase increased   1/8 (12.50%)  1
Aspartate aminotransferase increased   1/8 (12.50%)  1
Blood phosphorus increased   2/8 (25.00%)  2
Blood potassium decreased   1/8 (12.50%)  1
Blood potassium increased   1/8 (12.50%)  1
Weight decreased   3/8 (37.50%)  6
Metabolism and nutrition disorders   
Anorexia   1/8 (12.50%)  1
Hyperkalaemia   1/8 (12.50%)  4
Hyperphosphataemia   1/8 (12.50%)  1
Musculoskeletal and connective tissue disorders   
Arthralgia   2/8 (25.00%)  3
Back pain   1/8 (12.50%)  2
Bursitis   1/8 (12.50%)  1
Muscle spasms   4/8 (50.00%)  5
Muscular weakness   1/8 (12.50%)  2
Myalgia   2/8 (25.00%)  2
Pain in extremity   1/8 (12.50%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Tumour flare   4/8 (50.00%)  8
Nervous system disorders   
Dizziness   1/8 (12.50%)  1
Headache   1/8 (12.50%)  1
Hypoaesthesia   2/8 (25.00%)  3
Hypogeusia   3/8 (37.50%)  4
Lethargy   1/8 (12.50%)  1
Paraesthesia   1/8 (12.50%)  1
Tremor   1/8 (12.50%)  2
Psychiatric disorders   
Insomnia   1/8 (12.50%)  1
Libido decreased   1/8 (12.50%)  1
Respiratory, thoracic and mediastinal disorders   
Cough   3/8 (37.50%)  3
Dysphonia   1/8 (12.50%)  1
Dyspnoea   4/8 (50.00%)  4
Nasal congestion   1/8 (12.50%)  1
Pharyngolaryngeal pain   2/8 (25.00%)  4
Rhinorrhoea   4/8 (50.00%)  4
Sinus congestion   1/8 (12.50%)  1
Throat irritation   1/8 (12.50%)  1
Skin and subcutaneous tissue disorders   
Hyperhidrosis   1/8 (12.50%)  2
Night sweats   2/8 (25.00%)  4
Pruritus   2/8 (25.00%)  2
Rash   5/8 (62.50%)  11
Rash erythematous   1/8 (12.50%)  1
Rash papular   1/8 (12.50%)  1
Rash pruritic   1/8 (12.50%)  1
Surgical and medical procedures   
Tooth extraction   1/8 (12.50%)  1
Vascular disorders   
Hot flush   1/8 (12.50%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Senior Administrator, Compliance - Clinical Research Services
Organization: Roswell Park Cancer Institute
Phone: 716-845-2300
Layout table for additonal information
Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT01649791     History of Changes
Obsolete Identifiers: NCT01003821
Other Study ID Numbers: I 136908
NCI-2009-01327 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
First Submitted: July 23, 2012
First Posted: July 25, 2012
Results First Submitted: December 26, 2013
Results First Posted: February 27, 2014
Last Update Posted: June 30, 2016