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Trial record 62 of 494 for:    LENALIDOMIDE AND every 28 days

Lenalidomide in Comb w/Rituximab for Pts w/CD5+/CD20+ Hem Malignancies Who Relapse/Progress After Rituximab

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ClinicalTrials.gov Identifier: NCT00609869
Recruitment Status : Completed
First Posted : February 7, 2008
Results First Posted : September 1, 2014
Last Update Posted : September 17, 2015
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Lymphocytic Leukemia
Mantle Cell Lymphoma
Interventions Drug: Lenalidomide
Drug: Rituximab
Enrollment 29
Recruitment Details Participants were recruited at Moffitt Cancer Center from October 31, 2007 to March, 22, 2012.
Pre-assignment Details  
Arm/Group Title Experimental: Lenalidomide and Rituximab
Hide Arm/Group Description

28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.

Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.

Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15.

Period Title: Overall Study
Started 29
Completed 18
Not Completed 11
Reason Not Completed
Withdrawn, ischemic stroke             1
Severe hematologic toxicity             1
Withdrawal by Subject             1
Seizures             1
Severe tumor flare reaction             1
Hepatitis B infection             1
Rituximab reaction prior to lenalidomide             1
Mantle cell: not evaluable             4
Arm/Group Title Experimental: Lenalidomide and Rituximab
Hide Arm/Group Description

28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.

Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.

Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15.

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
All enrolled participants
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 29 participants
63
(41 to 80)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
<=18 years
0
   0.0%
Between 18 and 65 years
18
  62.1%
>=65 years
11
  37.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
10
  34.5%
Male
19
  65.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
1.Primary Outcome
Title Overall Response Rate (ORR)
Hide Description The sum of Complete Remission (CR) plus Partial Remission (PR) rates. Duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented, and must be confirmed greater than 8 weeks after first meeting CR or PR criteria. Response and progression for Chronic Lymphocytic Leukemia (CLL) were evaluated using 2008 updated National Cancer Institute-Sponsored Working Group Guidelines (NCI-WG) for Chronic Lymphocytic Leukemia. CR: all of the criteria must be met, and patients have the lack disease-related constitutional symptoms: PR: at least two of the criteria of Group A plus one of the criteria of group B have to be met. Group A Parameters: Lymphadenopathy; Hepatomegaly; Splenomegaly; Blood; Lymphocytes; Marrow. Group B Parameters: Platelet count; Hemoglobin; Neutrophils.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable chronic lymphocytic leukemia participants
Arm/Group Title Experimental: Lenalidomide and Rituximab
Hide Arm/Group Description:

28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.

Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.

Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
61
2.Secondary Outcome
Title Clinical Benefit Rate
Hide Description The ORR rate plus Stable Disease (SD). NCI-WG: SD is the absence of progressive disease (PD) and failure to achieve at least a PR; PD: at least one of the criteria of Group A or Group B has to be met.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable chronic lymphocytic leukemia participants
Arm/Group Title Experimental: Lenalidomide and Rituximab
Hide Arm/Group Description:

28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.

Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.

Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15.

Overall Number of Participants Analyzed 18
Measure Type: Number
Unit of Measure: percentage of participants
83.3
3.Secondary Outcome
Title Median Time to Treatment Failure (TTF)
Hide Description The time from start of therapy to death, Progressive Disease (PD) or initiation of next therapy. PD: at least one of the NCI-WG criteria of Group A or Group B has to be met.
Time Frame Up to 6 years
Hide Outcome Measure Data
Hide Analysis Population Description
All evaluable chronic lymphocytic leukemia participants
Arm/Group Title Experimental: Lenalidomide and Rituximab
Hide Arm/Group Description:

28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.

Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.

Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15.

Overall Number of Participants Analyzed 18
Median (95% Confidence Interval)
Unit of Measure: months
17.7
(5.6 to 29.8)
Time Frame 6 years, 3 months
Adverse Event Reporting Description All participants
 
Arm/Group Title Experimental: Lenalidomide and Rituximab
Hide Arm/Group Description

28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.

Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.

Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15.

All-Cause Mortality
Experimental: Lenalidomide and Rituximab
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Experimental: Lenalidomide and Rituximab
Affected / at Risk (%) # Events
Total   19/29 (65.52%)    
Blood and lymphatic system disorders   
Hemoglobin - low  1  5/29 (17.24%)  5
Neutrophils/granulocytes (ANC/AGC) - low  1  3/29 (10.34%)  3
Platelets - low  1  2/29 (6.90%)  2
Cardiac disorders   
Cardiac Arrhythmia - Other, AFib  1  1/29 (3.45%)  1
Cardiac General - Other, AFib/AFlu  1  1/29 (3.45%)  1
Hypotension  1  1/29 (3.45%)  1
Pericardial effusion (non-malignant)  1  1/29 (3.45%)  1
Gastrointestinal disorders   
Diarrhea  1  1/29 (3.45%)  1
Gastrointestinal - Other, cholilethiasis, gallbladder surgery  1  1/29 (3.45%)  1
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  4/29 (13.79%)  4
Fever (in the absence of neutropenia)  1  3/29 (10.34%)  3
Rigors/chills  1  2/29 (6.90%)  2
Death not associated with CTCAE term - Death  1  1/29 (3.45%)  1
Death not associated with CTCAE term - Disease progression NOS  1  1/29 (3.45%)  1
Pain - Abdomen NOS  1  2/29 (6.90%)  4
Pain - Chest wall  1  1/29 (3.45%)  1
Pain - Chest/thorax NOS  1  2/29 (6.90%)  2
Pain - Neck  1  2/29 (6.90%)  2
Pain - Pain NOS  1  1/29 (3.45%)  1
Pain NOS - Back  1  1/29 (3.45%)  1
Syndromes - Other, tumor fever  1  1/29 (3.45%)  1
Tumor flare  1  1/29 (3.45%)  1
Infections and infestations   
Febrile neutropenia  1  1/29 (3.45%)  1
Infection with Grade 3 or 4 neutrophils – Bladder (urinary)  1  1/29 (3.45%)  1
Infection with Grade 3 or 4 neutrophils – Blood  1  1/29 (3.45%)  1
Infection with Grade 3 or 4 neutrophils – Brain + Spinal cord (encephalomyelitis)  1  1/29 (3.45%)  1
Infection with Grade 3 or 4 neutrophils – Lung (pneumonia)  1  6/29 (20.69%)  9
Infection with Grade 3 or 4 neutrophils – Upper airway NOS  1  1/29 (3.45%)  1
Infection - Other, Port A Cath  1  5/29 (17.24%)  7
Infection - Other, unketiology  1  1/29 (3.45%)  1
Infection with normal ANC or Grade 1 or 2 neutrophils - Blood  1  2/29 (6.90%)  2
Infection with normal ANC or Grade 1 or 2 ANC or Grade 1 or 2  1  1/29 (3.45%)  2
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)  1  6/29 (20.69%)  9
Infection with normal ANC or Grade 1 or 2 neutrophils - Skin (cellulitis)  1  1/29 (3.45%)  1
Metabolism and nutrition disorders   
Calcium, serum-high (hypercalcemia)  1  1/29 (3.45%)  2
Tumor lysis syndrome  1  1/29 (3.45%)  1
Nervous system disorders   
Memory impairment  1  1/29 (3.45%)  1
Neuropathy: sensory  1  1/29 (3.45%)  1
Seizure  1  1/29 (3.45%)  1
Tremor  1  1/29 (3.45%)  1
Psychiatric disorders   
Mental status  1  1/29 (3.45%)  1
Renal and urinary disorders   
Renal failure  1  1/29 (3.45%)  1
Renal/Genitourinary - Other, chronic renal insufficiency  1  1/29 (3.45%)  1
Respiratory, thoracic and mediastinal disorders   
Cough  1  3/29 (10.34%)  3
Dyspnea (shortness of breath)  1  7/29 (24.14%)  9
Pleural effusion (non-malignant)  1  1/29 (3.45%)  1
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other, dermatitis  1  1/29 (3.45%)  1
Vascular disorders   
Thrombosis/embolism (vascular access-related)  1  1/29 (3.45%)  1
Vascular - Other, CVA/CNS ischemia  1  1/29 (3.45%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Experimental: Lenalidomide and Rituximab
Affected / at Risk (%) # Events
Total   28/29 (96.55%)    
Blood and lymphatic system disorders   
Neutrophils/granulocytes (ANC/AGC) - low  1  11/29 (37.93%)  52
Hemoglobin low  1  8/29 (27.59%)  13
Platelets - low  1  8/29 (27.59%)  23
Lymphopenia  1  2/29 (6.90%)  17
Edema: limb  1  13/29 (44.83%)  21
Lymphatics - Other  1  4/29 (13.79%)  4
Edema: head and neck  1  2/29 (6.90%)  6
Cardiac disorders   
Hypotension  1  3/29 (10.34%)  3
Ear and labyrinth disorders   
Auditory/Ear - Other  1  3/29 (10.34%)  6
Endocrine disorders   
Hot flashes/flushes  1  4/29 (13.79%)  6
Thyroid function, low (hypothyroidism)  1  2/29 (6.90%)  2
Eye disorders   
Vision-blurred vision  1  5/29 (17.24%)  6
Ocular/Visual - Other  1  4/29 (13.79%)  5
Gastrointestinal disorders   
Constitutional Symptoms -  1  18/29 (62.07%)  36
Nausea  1  12/29 (41.38%)  16
Gastrointestinal - Other  1  10/29 (34.48%)  13
Constipation  1  8/29 (27.59%)  11
Vomiting  1  7/29 (24.14%)  9
Anorexia  1  5/29 (17.24%)  7
Distension/bloating, abdominal  1  2/29 (6.90%)  3
Mucositis/stomatitis (functional/symptomatic) - Oral cavity  1  2/29 (6.90%)  2
General disorders   
Fatigue (asthenia, lethargy, malaise)  1  23/29 (79.31%)  70
Rigors/chills  1  12/29 (41.38%)  17
Fever (in the absence of neutropenia)  1  11/29 (37.93%)  14
Sweating (diaphoresis)  1  11/29 (37.93%)  19
Insomnia  1  7/29 (24.14%)  11
Weight loss  1  4/29 (13.79%)  6
Pain - Other  1  14/29 (48.28%)  43
Pain - Back  1  10/29 (34.48%)  21
Pain - Head/headache  1  10/29 (34.48%)  16
Pain - Abdomen NOS  1  6/29 (20.69%)  11
Pain - Chest/thorax NOS  1  5/29 (17.24%)  8
Pain - Lymph node  1  5/29 (17.24%)  8
Pain - Lymph node  1  5/29 (17.24%)  9
Pain - Neck  1  5/29 (17.24%)  9
Pain - Extremity-limb  1  4/29 (13.79%)  8
Pain - Throat/pharynx/larynx  1  4/29 (13.79%)  4
Pain - Chest wall  1  3/29 (10.34%)  4
Pain - Joint  1  3/29 (10.34%)  5
Pain - Oral cavity  1  2/29 (6.90%)  3
Pain - Pain NOS  1  2/29 (6.90%)  2
Pain - Stomach  1  2/29 (6.90%)  2
Tumor flare  1  3/29 (10.34%)  4
Immune system disorders   
Allergic reaction/hypersensitivity  1  2/29 (6.90%)  2
Infections and infestations   
Infection - Other  1  10/29 (34.48%)  19
Febrile neutropenia  1  8/29 (27.59%)  10
Infection with normal ANC or Grade 1 or 2 neutrophils - Lung (pneumonia)  1  6/29 (20.69%)  6
Infection with unknown ANC - Lung (pneumonia)  1  4/29 (13.79%)  6
Infection with Grade 3 or 4 neutrophils - Lung (pneumonia)  1  3/29 (10.34%)  3
Infection with unknown ANC - Bronchus  1  2/29 (6.90%)  2
Infection with unknown ANC - Sinus  1  2/29 (6.90%)  2
Infection with unknown ANC - Skin (cellulitis)  1  2/29 (6.90%)  2
Metabolism and nutrition disorders   
Glucose, serum-high (hyperglycemia)  1  3/29 (10.34%)  3
Calcium, serum-high (hypercalcemia)  1  2/29 (6.90%)  6
Musculoskeletal and connective tissue disorders   
Musculoskeletal/Soft Tissue - Other  1  8/29 (27.59%)  14
Neoplasms benign, malignant and unspecified (incl cysts and polyps)   
Secondary Malignancy - possibly related to cancer treatment  1  2/29 (6.90%)  2
Nervous system disorders   
Dizziness  1  7/29 (24.14%)  9
Neuropathy: sensory  1  7/29 (24.14%)  14
Neurology - Other  1  6/29 (20.69%)  11
Memory impairment  1  3/29 (10.34%)  3
Tremor  1  3/29 (10.34%)  3
Psychiatric disorders   
Mood alteration - Anxiety  1  4/29 (13.79%)  5
Mood alteration - Depression  1  4/29 (13.79%)  4
Renal and urinary disorders   
Renal/Genitourinary - Other  1  3/29 (10.34%)  5
Urinary frequency/urgency  1  2/29 (6.90%)  4
Respiratory, thoracic and mediastinal disorders   
Cough  1  15/29 (51.72%)  34
Dyspnea (shortness of breath)  1  11/29 (37.93%)  14
Pulmonary/Upper Respiratory - Other  1  8/29 (27.59%)  21
Hypoxia  1  2/29 (6.90%)  3
Pleural effusion (non-malignant)  1  2/29 (6.90%)  2
Voice changes/dysarthria  1  2/29 (6.90%)  2
Allergic rhinitis  1  3/29 (10.34%)  4
Skin and subcutaneous tissue disorders   
Dermatology/Skin - Other  1  12/29 (41.38%)  28
Pruritus/itching  1  9/29 (31.03%)  23
Bruising (in absence of Grade 3 or 4 thrombocytopenia)  1  4/29 (13.79%)  4
Rash/desquamation  1  4/29 (13.79%)  6
Dry skin  1  2/29 (6.90%)  2
Rash: acne/acneiform  1  2/29 (6.90%)  2
Rash: hand-foot skin reaction  1  2/29 (6.90%)  2
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (3.0)
The 4 Mantle Cell participants were not evaluated for Outcome Measures due to their low enrollment.
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: Javier Pinilla-Ibarz
Organization: H. Lee Moffitt Cancer Center and Research Institute
Phone: 813-745-1387
EMail: javier.pinilla@moffitt.org
Layout table for additonal information
Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00609869     History of Changes
Other Study ID Numbers: MCC-14978
RV-CLL-PI-067 ( Other Identifier: Celgene )
First Submitted: January 24, 2008
First Posted: February 7, 2008
Results First Submitted: August 20, 2014
Results First Posted: September 1, 2014
Last Update Posted: September 17, 2015