ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 16 of 92 for:    CLL [CONDITION] Lenalidomide [TREATMENT]

Study of Bendamustine/Rituxan Induction Chemotherapy With Revlimid Maintenance for Relapsed/Refractory CLL and SLL

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00974233
Recruitment Status : Completed
First Posted : September 10, 2009
Results First Posted : July 13, 2017
Last Update Posted : July 13, 2017
Sponsor:
Collaborator:
Celgene Corporation
Information provided by (Responsible Party):
University of Wisconsin, Madison

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Chronic Lymphocytic Leukemia
Small Lymphocytic Lymphoma
Interventions: Drug: Bendamustine
Drug: Rituximab
Drug: Lenalidomide

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Research subjected from the University of Wisconsin and 7 Wisconsin Oncology Network institutions were enrolled from October 2009 to November 2011. Subjects were enrolled from outpatient hematology clinics at each participating institution.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Induction Chemoimmunotherapy + Maintenance Lenalidomide Induction therapy: Bendamustine 90 mg/m2 IV on days 1 & 2 + rituximab 375 mg/m2 IV on day 1 (permitted on day 2 of cycle 1) every 28 days for total of 6 treatment cycles. Maintenance therapy: Lenalidomide 5-10 mg orally continuously of each 28-day cycles for total of 12 treatment cycles.

Participant Flow for 2 periods

Period 1:   Induction Chemoimmunotherapy
    Induction Chemoimmunotherapy + Maintenance Lenalidomide
STARTED   34 
COMPLETED   19 
NOT COMPLETED   15 
Death                2 
Lack of Efficacy                5 
Adverse Event                7 
Withdrawal by Subject                1 

Period 2:   Maintenance Lenalidomide
    Induction Chemoimmunotherapy + Maintenance Lenalidomide
STARTED   19 
COMPLETED   6 
NOT COMPLETED   13 
Lack of Efficacy                5 
Adverse Event                8 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Subjects with progressive chronic lymphocytic leukemia/small lymphocytic lymphoma receiving 1-5 prior unique treatment regimens.

Reporting Groups
  Description
Overall Study Population Patient population with chronic lymphocytic leukemia/small lymphocytic lymphoma with progressive disease in need of therapy after at least 1 prior chemotherapy regimen, but no more than 5 prior unique chemotherapy regimens (retreatment with identical regimen did not count as a unique regimen).

Baseline Measures
   Overall Study Population 
Overall Participants Analyzed 
[Units: Participants]
 34 
Age 
[Units: Years]
Median (Full Range)
 67 
 (48 to 86) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      10  29.4% 
Male      24  70.6% 
ECOG performance status [1] 
[Units: Participants]
 
ECOG performance status 0-1   32 
ECOG performance status 2   2 
[1] ECOG performance status (PS) evaluated clinically in all patients on a scale from 0-5, with higher ECOG PS indicating worse functional impairment (i.e., ECOG PS of zero = asymptomatic, fully functional patient; ECOG PS of 5 = death).
Disease staging [1] 
[Units: Participants]
 
Rai stage 1/2 (CLL)   12 
Rai stage 3/4 (CLL)   14 
Ann Arbor stage 1/2 (SLL)   1 
Ann Arbor 3/4 (SLL)   7 
[1]

Rai staging is a clinical evaluation taking into account blood counts and physical exam findings, with staging ranging from 0-4 (more advanced staging corresponding with higher numbers).

Ann Arbor staging is an evaluation of physical exam finding combined with imaging evaluation (usually CT imaging) to determine extent of lymph node enlargement, with staging ranging from 1-4 (more advanced staging corresponding with higher numbers).

Median prior therapies [1] 
[Units: Prior therapies]
Median (Full Range)
 2 
 (1 to 4) 
[1] Describes number of unique prior therapies received by subjects, including monoclonal antibody therapy (i.e., single-agent rituximab) or cytotoxic chemotherapy-based therapies. Retreatment with an identical regimen was not counted as a unique therapy. Subjects required at least one cytotoxic chemotherapy-based therapy for eligibility.
Prior therapy with fludarabine 
[Units: Participants]
 
Prior fludarabine-based therapy   23 
No previous fludrarabine exposure   11 
Refractory to most recent therapy 
[Units: Participants]
 
Refractory to most recent therapy   4 
Not refractory to most recent therapy   30 
Elevated serum lactate dehydrogenase (LDH) level [1] 
[Units: Participants]
 
Enrollment LDH elevated   20 
Enrollment LDH not elevated   14 
[1] Lactate dehydrogenase (LDH) is associated with cell growth and turnover in the body. Higher levels of LDH tend to be associated with more rapid tumor growth and is a marker of higher risk lymphoma/leukemia.
Baseline cytogenetics 
[Units: Participants]
 
17p or 11q deletions   11 
13q deletion   2 
Trisomy 12   8 
Normal   3 
Unknown   10 
Prior therapy with rituximab 
[Units: Participants]
 
Prior therapy with rituximab   27 
No prior therapy with rituximab   7 


  Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) ]

2.  Primary:   Progression-free Survival   [ Time Frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) ]

3.  Secondary:   Objective Response Rate (Complete + Partial Responses)   [ Time Frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) ]

4.  Secondary:   Toxicities Observed With Induction Chemotherapy and Maintenance Therapy   [ Time Frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) ]

5.  Secondary:   Overall Survival   [ Time Frame: 42 months (6 months induction therapy, 12 months maintenance, 24 months long-term follow-up) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.


Results Point of Contact:  
Name/Title: Julie E. Chang, MD
Organization: University of Wisconsin
phone: 608-262-3970
e-mail: jc2@medicine.wisc.edu



Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00974233     History of Changes
Other Study ID Numbers: HO08405
RV-CLL/SLL-PI-397
First Submitted: September 9, 2009
First Posted: September 10, 2009
Results First Submitted: May 17, 2016
Results First Posted: July 13, 2017
Last Update Posted: July 13, 2017