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Trial record 26 of 179 for:    LENALIDOMIDE AND Leukemia

Lenalidomide Following Fludarabine/Rituximab (FR) in Untreated Chronic Lymphocytic Leukemia (CLL)

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ClinicalTrials.gov Identifier: NCT00860457
Recruitment Status : Completed
First Posted : March 12, 2009
Results First Posted : August 18, 2014
Last Update Posted : November 21, 2018
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
Georgetown University

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Chronic Lymphocytic Leukemia
Interventions Drug: Rituximab
Drug: Fludarabine
Drug: Lenalidomide
Enrollment 22
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Chemotherapy
Hide Arm/Group Description Fludarabine/Rituximab followed by Lenalidomide
Period Title: Overall Study
Started 22
Completed 11
Not Completed 11
Arm/Group Title Chemotherapy
Hide Arm/Group Description

Fludarabine/Rituximab followed by Lenalidomide

Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles

Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles

Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles

Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
60.5
(41 to 78)
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
<=18 years
0
   0.0%
Between 18 and 65 years
14
  63.6%
>=65 years
8
  36.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
7
  31.8%
Male
15
  68.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
 100.0%
1.Primary Outcome
Title Complete Response Rate
Hide Description Response assessments were made per the NCI working group criteria for CLL (Hallek et al, Blood, 2008). Complete response rate is defined as an achievement of all of the following: Peripheral blood lymphocytes (evaluated by blood and differential count) below 4 × 109/L (4000/μL), absence of significant lymphadenopathy (lymph nodes must be < 1.5 cm), absence of splenomegaly and hepatomegaly, absence of constitutional symptoms, normal blood counts, and bone marrow sample must be at least normocellular for age, with less than 30% of nucleated cells being lymphocytes. Lymphoid nodules should be absent.
Time Frame 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Chemotherapy
Hide Arm/Group Description:

Fludarabine/Rituximab followed by Lenalidomide

Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles

Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles

Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles

Overall Number of Participants Analyzed 22
Measure Type: Number
Unit of Measure: percentage of patients
36
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Chemotherapy
Hide Arm/Group Description

Fludarabine/Rituximab followed by Lenalidomide

Rituximab: 375 mg/m2 IV infusion Day 1 of each 28-day cycle for maximum of 6 cycles

Fludarabine: 25 mg/m2 IV Days 1-5 of each 28-day cycle for maximum of 6 cycles

Lenalidomide: 5-10 mg PO daily on Days 1-21 of each 28-day cycle for a maximum of 6 cycles

All-Cause Mortality
Chemotherapy
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Chemotherapy
Affected / at Risk (%)
Total   1/22 (4.55%) 
Blood and lymphatic system disorders   
Fatal septic shock secondary to bacteremia   1/22 (4.55%) 
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 5%
Chemotherapy
Affected / at Risk (%)
Total   13/22 (59.09%) 
Blood and lymphatic system disorders   
grade 3/4 neutropenia  [1]  13/22 (59.09%) 
grade 1/2 anemia  [2]  12/22 (54.55%) 
grade 3/4 anemia  [3]  4/22 (18.18%) 
grade 1/2 neutropenia  [4]  2/22 (9.09%) 
grade 1/2 thrombocytopenia  [5]  2/22 (9.09%) 
grade 3/4 thrombocytopneia  [6]  4/22 (18.18%) 
Indicates events were collected by systematic assessment
[1]
grade 3/4 neutropenia during FR: 59% and during lenalidomide: 27%
[2]
grade 1/2 anemia during FR: 54% ; and during lenalidomide: 20%
[3]
grade 3/4 anemia during FR: 18% and during lenalidomide: 0%
[4]
grade 1/2 neutropenia during FR: 9% and during lenalidomide: 27%
[5]
grade 1/2 thrombocytopenia during FR: 9% and during lenalidomide: 40%
[6]
grade 3/4 thrombocytopenia during FR: 18% and during lenalidomide: 0%
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: Dr. Bruce D. Cheson
Organization: Lombardi Comprehensive Cancer Center, Georgetown University Hospital
Phone: 202-444-7932
EMail: bdc4@georgetown.edu
Layout table for additonal information
Responsible Party: Georgetown University
ClinicalTrials.gov Identifier: NCT00860457     History of Changes
Other Study ID Numbers: RV-CLL-PI-089
First Submitted: March 10, 2009
First Posted: March 12, 2009
Results First Submitted: February 24, 2014
Results First Posted: August 18, 2014
Last Update Posted: November 21, 2018