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Study of Lenalidomide in Previously Untreated, Symptomatic Chronic Lymphocytic Leukemia (CLL) (Rev-CLL)

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ClinicalTrials.gov Identifier: NCT00751296
Recruitment Status : Terminated (Seven years of follow-up & final analysis done in Dec 2012.)
First Posted : September 11, 2008
Results First Posted : May 12, 2016
Last Update Posted : June 16, 2016
Sponsor:
Collaborator:
Celgene
Information provided by (Responsible Party):
University Health Network, Toronto

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Chronic Lymphocytic Leukaemia
Intervention: 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
This was a single site, Investigator initiated study. Patients gave informed consent according to institutional and university human experimentation committee requirements. Previously untreated B-cell CLL patients >/= 18 years of age were eligible if they met the eligibility criteria.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Study was halted and the protocol amended after severe toxicities were noted in the first 2 study patients when they were dosed as per the initial protocol dosing guidelines. Their data was not included in the analysis and additional 25 eligible patients were enrolled and their data was analyzed.

Reporting Groups
  Description
Lenalidiomide

Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.

Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).

Dose escalation beyond 10 mg daily to a maximum of 25 mgs daily was permitted for nonresponders.


Participant Flow:   Overall Study
    Lenalidiomide
STARTED   27 [1] 
COMPLETED   25 
NOT COMPLETED   2 
Adverse Event                2 
[1] The start date of the study was 25 August 2006.



  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.
No text entered.

Reporting Groups
  Description
Lenalidiomide

Lenalidomide target dose of 10 mg PO OD X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28-day cycle.

Lenalidomide: Subjects will receive lenalidomide, starting at 2.5 mg daily x 3 weeks (days 1-21) and escalating up to a target dose of 10 mg daily X 3 weeks (days 1-21) followed by 1 week off therapy (days 22-28) on a 28 day cycle. Patients will be treated with lenalidomide until disease progression or 2 cycles past CR. (no maximum of cycles).


Baseline Measures
   Lenalidiomide 
Overall Participants Analyzed 
[Units: Participants]
 25 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   17 
>=65 years   8 
Age 
[Units: Years]
Median (Full Range)
 60 
 (33 to 78) 
Gender 
[Units: Participants]
 
Female   9 
Male   16 
Region of Enrollment 
[Units: Participants]
 
Canada   25 


  Outcome Measures

1.  Primary:   To Assess the Efficacy (Response Rate) of Oral Lenalidomide in the Treatment of Patients With Symptomatic, Previously Untreated, Chronic Lymphocytic Leukemia (CLL)   [ Time Frame: Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis. ]

2.  Secondary:   Percentage of Participants With Progression-free Survival (PFS) and Overall Survival (OS).   [ Time Frame: Patients will be treated with lenalidomide until disease progression or 2 cycles past CR (no maximum of cycles). Participants were followed upto 53.2 months for the final data analysis. ]


  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
Original study protocol used a starting lenalidomide dose of 10mg OD for 21days of a 28-day cycle, escalating weekly by 5mg to a target of 25mg daily. Toxicities reported with the first two enrolled patients lead to the current protocol amendment.


  More Information

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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Christine Chen
Organization: University Health Network - Princess Margaret Cancer Centre
phone: 416-946-2827
e-mail: Christine.Chen@uhn.ca



Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00751296     History of Changes
Other Study ID Numbers: Rev-06-0099
RV-CLL-PI-0099 ( Other Identifier: Study sponsor )
First Submitted: September 10, 2008
First Posted: September 11, 2008
Results First Submitted: December 29, 2015
Results First Posted: May 12, 2016
Last Update Posted: June 16, 2016