RESPeCT: Revlimid Early Stage Poor Prognosis Chronic Lymphocytic Leukaemia (CLL) Trial (RESPeCT)
|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: NCT01127542|
Recruitment Status : Terminated (Potential safety issue of second primary malignancies in patients treated with lenalidomide.)
First Posted : May 21, 2010
Last Update Posted : December 5, 2011
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukaemia||Drug: Lenalidomide||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Single Arm Phase II Study to Investigate the Use of Lenalidomide in the Treatment of Patients With Early Stage CLL Associated With Poor Prognostic Factors|
|Study Start Date :||May 2010|
|Actual Study Completion Date :||December 2011|
|Experimental: Lenalidomide for early stage poor prognosis CLL||
Daily oral lenalidomide. Starting dose of 2.5mg daily, escalating to target dose of 10mg daily.
- Complete Remission with clearance of Minimal Residual Disease (MRD) [ Time Frame: 6 months (or earlier if clinically indicated) ]
- Event free survival [ Time Frame: Treatment/ progression/ death details collected at all visits (6 visits per month in dose escalation, 1 visit per month in dose maintenance, annual in long-term follow-up) ]Defined as interval from the first treatment day to the first sign of disease progression, treatment for relapse or death (whichever occurs first).
- Safety & tolerability of treatment (occurrence of adverse events) [ Time Frame: Assessed at all visits (6 visits per month in dose escalation, 1 visit per month in dose maintenance, annual in long-term follow-up) ]Adverse events will be monitored according to NCI CTCAE v3 from screening until 1 month after treatment discontinuation/ trial closure. Adverse event data will be captured at all visits (6 visits per month in dose escalation, 1 visit per month in dose maintenance). Adverse event data will be assessed by blood tests, physical exam/ vital signs and pregnancy testing.
- Time to next treatment [ Time Frame: Treatment details collected at all visits (6 visits per month in dose escalation, 1 visit per month in dose maintenance, annual in long-term follow-up) ]Defined as interval between first treatment day on the study protocol to the first day of the next course of CLL therapy following disease progression.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01127542
|The Royal Bournemouth Hospital|
|Bournemouth, Dorset, United Kingdom, BH7 7DW|
|Heart of England NHS Foundation Trust|
|Birmingham, United Kingdom, B9 5SS|
|Cambridge, United Kingdom, CB2 0QQ|
|University Hospital of Wales|
|Cardiff, United Kingdom, CF14 4XW|
|St James's University Hospital|
|Leeds, United Kingdom, LS9 7TF|
|The Royal Liverpool and Broadgreen University Hospital|
|Liverpool, United Kingdom, L7 8XP|
|King's College Hospital|
|London, United Kingdom, SE5 9RS|
|The Christie NHS Foundation Trust|
|Manchester, United Kingdom, M20 4BX|
|Mid Yorkshire Hospitals NHS Trust|
|Wakefield, United Kingdom, WF1 4DG|
|Principal Investigator:||Adrian Bloor||The Christie NHS Foundation Trust|