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Trial record 61 of 179 for:    LENALIDOMIDE AND Leukemia

Fludarabine, Rituximab, and Lenalidomide in Minimally Treated/Untreated Patients With Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT00536341
Recruitment Status : Completed
First Posted : September 27, 2007
Results First Posted : May 4, 2016
Last Update Posted : January 16, 2017
Sponsor:
Collaborators:
Celgene Corporation
Genentech, Inc.
Information provided by (Responsible Party):
SCRI Development Innovations, LLC

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: lenalidomide
Drug: Rituximab
Drug: Fludarabine
Enrollment 64
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6 Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
Period Title: Overall Study
Started 10 54
Completed 5 43
Not Completed 5 11
Arm/Group Title Dose Level 1 Dose Level 2 Total
Hide Arm/Group Description Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6 Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6 Total of all reporting groups
Overall Number of Baseline Participants 10 54 64
Hide Baseline Analysis Population Description
All enrolled and treated patients
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 10 participants 54 participants 64 participants
67
(49 to 74)
63
(44 to 82)
64
(44 to 82)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 54 participants 64 participants
Female
2
  20.0%
25
  46.3%
27
  42.2%
Male
8
  80.0%
29
  53.7%
37
  57.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 54 participants 64 participants
10 54 64
1.Primary Outcome
Title Number of Adverse Events as a Measure of Safety and Tolerability
Hide Description Recorded from first treatment until 30 days after last treatment and assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 4.0
Time Frame 63 months
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
Overall Number of Participants Analyzed 10 54
Measure Type: Number
Unit of Measure: participants
Fatigue 8 40
Neutropenia 7 41
Anemia 8 34
Leukopenia 7 34
Thrombocytopenia 8 30
Rash 6 27
Nausea 7 25
Constipation 3 15
Anorexia 4 12
Fever 3 13
Hyperhidrosis 3 13
Arthralgia 1 14
Edema Limbs 3 12
Pruritus 0 15
Back pain 3 11
Headache 1 13
Chills 2 11
Insomnia 2 11
Vomiting 2 11
Dysgeusia 1 11
Abdominal Pain 2 9
Allergic Reaction 4 7
Diarrhea 3 8
Cough 2 8
Dizziness 2 8
Dyspnea 0 10
Hypotension 1 9
Myalgia 2 8
2.Primary Outcome
Title Complete Response Rate
Hide Description An improvement in complete response to at least 60% following treatment, assessed using CT scans, clinical/lab examinations, and bone marrow aspirations, as defined by National Cancer Institute Working Group Response Criteria.
Time Frame At 12 weeks during treatment and 2 months post-treatment until disease progression, projected 8 months
Hide Outcome Measure Data
Hide Analysis Population Description
All patients deemed evaluable and evaluated for response
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description:
Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
Overall Number of Participants Analyzed 9 41
Measure Type: Number
Unit of Measure: participants
4 9
3.Secondary Outcome
Title Progression-Free Survival
Hide Description Measured from first treatment to disease progression and assessed using Kaplan-Meier methods.
Time Frame Every 3 months during treatment until disease progression and every 6 months thereafter, up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients, all dose levels
Arm/Group Title All Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: months
24.64 [1] 
(21.125 to NA)
[1]
Not reached at this time
4.Secondary Outcome
Title Overall Survival
Hide Description Defined as the time from Day 1 of treatment administration to date of death from any cause, estimated using Kaplan-Meier methods.
Time Frame Every 3 months until treatment discontinuation, expected average of 6 months and then every 6 months thereafter up to 5 years
Hide Outcome Measure Data
Hide Analysis Population Description
All treated patients, all dose levels
Arm/Group Title All Patients
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 64
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
[1]
Median OS not reached at this time
Time Frame 63 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Dose Level 1 Dose Level 2
Hide Arm/Group Description Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6 Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
All-Cause Mortality
Dose Level 1 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Dose Level 1 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   2/10 (20.00%)   16/54 (29.63%) 
Gastrointestinal disorders     
Abdominal pain  1  1/10 (10.00%)  1/54 (1.85%) 
Diarrhea  1  0/10 (0.00%)  1/54 (1.85%) 
Mucositis  1  0/10 (0.00%)  1/54 (1.85%) 
Nausea  1  0/10 (0.00%)  1/54 (1.85%) 
General disorders     
Chills  1  0/10 (0.00%)  1/54 (1.85%) 
Edema limbs  1  0/10 (0.00%)  1/54 (1.85%) 
Fatigue  1  0/10 (0.00%)  1/54 (1.85%) 
Fever  1  0/10 (0.00%)  2/54 (3.70%) 
Immune system disorders     
Allergic Reaction  1  0/10 (0.00%)  1/54 (1.85%) 
Infections and infestations     
Bronchial Infection  1  0/10 (0.00%)  2/54 (3.70%) 
Infections and infestations - Other, gastrointestinal infection NOS  1  0/10 (0.00%)  1/54 (1.85%) 
Infections and infestations - Other, pneumonia  1  1/10 (10.00%)  1/54 (1.85%) 
Infections and infestations - Other, unspecified  1  0/10 (0.00%)  1/54 (1.85%) 
Sepsis  1  0/10 (0.00%)  1/54 (1.85%) 
Investigations     
Lymphocyte count decreased  1  0/10 (0.00%)  1/54 (1.85%) 
Neutrophil count decreased  1  0/10 (0.00%)  1/54 (1.85%) 
White blood cell decreased  1  0/10 (0.00%)  2/54 (3.70%) 
Metabolism and nutrition disorders     
Tumor Lysis Syndrome  1  0/10 (0.00%)  1/54 (1.85%) 
Musculoskeletal and connective tissue disorders     
Generalized muscle weakness  1  0/10 (0.00%)  1/54 (1.85%) 
Skin and subcutaneous tissue disorders     
Rash  1  0/10 (0.00%)  2/54 (3.70%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Dose Level 1 Dose Level 2
Affected / at Risk (%) Affected / at Risk (%)
Total   10/10 (100.00%)   54/54 (100.00%) 
Blood and lymphatic system disorders     
Anemia  1  8/10 (80.00%)  34/54 (62.96%) 
Febrile neutropenia  1  0/10 (0.00%)  4/54 (7.41%) 
Gastrointestinal disorders     
Nausea  1  7/10 (70.00%)  25/54 (46.30%) 
Constipation  1  3/10 (30.00%)  15/54 (27.78%) 
Vomiting  1  2/10 (20.00%)  11/54 (20.37%) 
Abdominal pain  1  2/10 (20.00%)  9/54 (16.67%) 
Diarrhea  1  3/10 (30.00%)  8/54 (14.81%) 
Gastroesophageal reflux disease  1  1/10 (10.00%)  7/54 (12.96%) 
Mucositis  1  0/10 (0.00%)  6/54 (11.11%) 
General disorders     
Fatigue  1  8/10 (80.00%)  40/54 (74.07%) 
Fever  1  3/10 (30.00%)  13/54 (24.07%) 
Edema limbs  1  3/10 (30.00%)  12/54 (22.22%) 
Chills  1  2/10 (20.00%)  11/54 (20.37%) 
Immune system disorders     
Allergic reaction  1  4/10 (40.00%)  7/54 (12.96%) 
Infections and infestations     
Sinusitis  1  0/10 (0.00%)  7/54 (12.96%) 
Infections and infestations - Other, unspecified  1  1/10 (10.00%)  4/54 (7.41%) 
Upper respiratory infection  1  0/10 (0.00%)  4/54 (7.41%) 
Investigations     
Neutrophil count decreased  1  7/10 (70.00%)  41/54 (75.93%) 
White blood cell decreased  1  7/10 (70.00%)  34/54 (62.96%) 
Platelet count decreased  1  8/10 (80.00%)  30/54 (55.56%) 
Aspartate aminotransferase increased  1  0/10 (0.00%)  8/54 (14.81%) 
Alanine aminotransferase increased  1  1/10 (10.00%)  5/54 (9.26%) 
Alkaline phosphatase increased  1  1/10 (10.00%)  5/54 (9.26%) 
Investigations - Other, LDH increased  1  0/10 (0.00%)  5/54 (9.26%) 
Blood bilirubin increased  1  0/10 (0.00%)  4/54 (7.41%) 
Metabolism and nutrition disorders     
Anorexia  1  4/10 (40.00%)  12/54 (22.22%) 
Hyperkalemia  1  2/10 (20.00%)  6/54 (11.11%) 
Dehydration  1  0/10 (0.00%)  5/54 (9.26%) 
Hyperglycemia  1  0/10 (0.00%)  4/54 (7.41%) 
Hyponatremia  1  1/10 (10.00%)  3/54 (5.56%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  1/10 (10.00%)  14/54 (25.93%) 
Back pain  1  3/10 (30.00%)  11/54 (20.37%) 
Myalgia  1  2/10 (20.00%)  8/54 (14.81%) 
Pain in extremity  1  1/10 (10.00%)  7/54 (12.96%) 
Flank pain  1  1/10 (10.00%)  3/54 (5.56%) 
Nervous system disorders     
Headache  1  1/10 (10.00%)  13/54 (24.07%) 
dysgeusia  1  1/10 (10.00%)  11/54 (20.37%) 
Dizziness  1  2/10 (20.00%)  8/54 (14.81%) 
Peripheral sensory neuropathy  1  2/10 (20.00%)  7/54 (12.96%) 
Tremor  1  1/10 (10.00%)  4/54 (7.41%) 
Psychiatric disorders     
Insomnia  1  2/10 (20.00%)  11/54 (20.37%) 
depression  1  0/10 (0.00%)  5/54 (9.26%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  2/10 (20.00%)  8/54 (14.81%) 
Dyspnea  1  0/10 (0.00%)  10/54 (18.52%) 
Allergic rhinitis  1  3/10 (30.00%)  4/54 (7.41%) 
Nasal congestion  1  1/10 (10.00%)  6/54 (11.11%) 
Epistaxis  1  0/10 (0.00%)  4/54 (7.41%) 
Sore throat  1  2/10 (20.00%)  2/54 (3.70%) 
Skin and subcutaneous tissue disorders     
Rash  1  6/10 (60.00%)  27/54 (50.00%) 
Hyperhidrosis  1  3/10 (30.00%)  13/54 (24.07%) 
Pruritus  1  0/10 (0.00%)  15/54 (27.78%) 
Dry skin  1  0/10 (0.00%)  7/54 (12.96%) 
Skin and subcutaneous tissue disorders - Other, erythema  1  3/10 (30.00%)  1/54 (1.85%) 
Vascular disorders     
Hypotension  1  1/10 (10.00%)  9/54 (16.67%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE (4.0)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The sponsor can review/embargo results communications prior to public release for a period that is >60 but =180 days from date submitted to sponsor, who may require changes to the communication in order to remove specifically identified confidential information (other than study data) and/or delay the proposed publication to enable the sponsor to seek patent protection for inventions. The PI may not publish its results until 18 mos. after the trial has been completed at all sites
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: John D Hainsworth, MD
Organization: Sarah Cannon Research Institute
Phone: 1-877-691-7274
EMail: asksarah@scresearch.net
Layout table for additonal information
Responsible Party: SCRI Development Innovations, LLC
ClinicalTrials.gov Identifier: NCT00536341     History of Changes
Other Study ID Numbers: SCRI CLL 02
First Submitted: September 24, 2007
First Posted: September 27, 2007
Results First Submitted: March 31, 2016
Results First Posted: May 4, 2016
Last Update Posted: January 16, 2017