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RESPeCT: Revlimid Early Stage Poor Prognosis Chronic Lymphocytic Leukaemia (CLL) Trial

Sponsor
The Christie NHS Foundation Trust (Other)
Overall Status
Terminated
CT.gov ID
NCT01127542
Collaborator
Celgene Corporation (Industry), Leukemia Research Fund (Other)
1
Enrollment
9
Locations
1
Arm
19
Duration (Months)
0.1
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The majority of patients with CLL are diagnosed with early stage disease (Binet stage A or Rai stage 0/I). Standard management of such patients is observation, and with median age at diagnosis of 72 and median time to progression of >5-10 years, many will never require treatment. In contrast, a proportion of patients have more aggressive disease, and over the last decade, a number of molecular factors have been identified that may be used to identify patients with poor prognosis disease . Each is associated with shortened time to treatment (typically less than 3 years in patients with 2 of more factors), reduced survival, with in the case of p53/ATM inactivation, resistance to treatment. Whether it is possible to improve the outcome of patients with CLL and adverse prognostic factors by early intervention with treatment is unknown. Several trials in the 1980's demonstrated that treatment of stage A CLL with conventional chemotherapy (chlorambucil) did not alter the natural history of the disease, although none of these studies stratified patients according to risk. The choice of alternative potential therapeutic agents is limited; they should be effective in patients with adverse prognostic factors, have acceptable toxicity, be able to overcome the drug resistance associated with p53/ATM inactivation and ideally be orally administered. Two recent phase II trials have demonstrated that Lenalidomide is effective in the treatment of relapsed/refractory disease. Importantly, both studies included a high proportion of patients with adverse prognostic factors including p53 inactivation. The principle objective of this study is to investigate the efficacy of Lenalidomide in achieving disease response (complete remission and clearance of minimal residual disease) in patients with poor risk early stage disease, together with assessment of safety and tolerability.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
1 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 1, 2010
Actual Study Completion Date :
Dec 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Lenalidomide for early stage poor prognosis CLL

Drug: Lenalidomide
Daily oral lenalidomide. Starting dose of 2.5mg daily, escalating to target dose of 10mg daily.
Other Names:
  • Revlimid
  • CC-5013

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Complete Remission with clearance of Minimal Residual Disease (MRD) [6 months (or earlier if clinically indicated)]

    Secondary Outcome Measures

    1. Event free survival [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).

    2. Safety & tolerability of treatment (occurrence of adverse events) [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.

    3. Time to next treatment [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Binet stage A CLL

    • 2 or more risk factors:

    • Unmutated IgVH locus (≥98% homology to germline sequence)

    • CD38 expression (>7%)

    • Deletion of chromosome 11q22 (>20% by FISH)

    • Deletion of chromosome 17p13 (>10% by FISH)

    • Over 18 years old

    • Capable to provide written informed consent

    • ECOG performance status < 2

    • Life expectancy > 2 years

    • Must agree to not share lenalidomide with someone else

    • Must agree not to donate blood whilst taking the study drug and for one week after discontinuation of treatment.

    • Female subjects of childbearing potential and all male subjects must agree to comply with the stipulations of the pregnancy prevention plan.

    Exclusion Criteria:

    • Current or recent (within the last 1 month) participation in another clinical trial investigating the action of an investigational medicinal product for the treatment of CLL

    • Pregnant or lactating

    • Known positivity for human immunodeficiency virus (HIV) types 1 or 2

    • Prior history of malignancies, other than CLL, unless the subject was treated with curative intent and has been free of the disease for ≥3 years. Exceptions include the following:

    • Basal cell carcinoma of the skin

    • Squamous cell carcinoma of the skin

    • Carcinoma in situ of the cervix

    • Carcinoma in situ of the breast

    • Significantly abnormal renal or hepatic function (creatinine clearance < 60ml/min, serum aspartate aminotransferase (AST) > 3 x upper limit of normal (ULN), serum bilirubin > 34μmol/l)

    • Laboratory tumour lysis syndrome according to the Cairo-Bishop classification. Subjects may be enrolled when these abnormalities have been corrected.

    • Peripheral neuropathy (grade ≥ 2)

    • Previous treatment for CLL

    • Previous treatment with Thalidomide or immunomodulatory derivative drugs (including Lenalidomide)

    • Treatment with corticosteroids (for CLL or other indications) < 28 days from study entry

    • Evidence of Richter's transformation

    • Unsupported absolute neutrophil count < 1x109/l or platelet count < 50x10*9/l not due to CLL

    • Active autoimmune haemolytic anaemia or thrombocytopenia

    • Any other medical or psychological condition that in the view of the investigator would be likely to impact compliance with the protocol or interfere with trial treatment.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Royal Bournemouth Hospital Bournemouth Dorset United Kingdom BH7 7DW
    2 Heart of England NHS Foundation Trust Birmingham United Kingdom B9 5SS
    3 Addenbrooke's Hospital Cambridge United Kingdom CB2 0QQ
    4 University Hospital of Wales Cardiff United Kingdom CF14 4XW
    5 St James's University Hospital Leeds United Kingdom LS9 7TF
    6 The Royal Liverpool and Broadgreen University Hospital Liverpool United Kingdom L7 8XP
    7 King's College Hospital London United Kingdom SE5 9RS
    8 The Christie NHS Foundation Trust Manchester United Kingdom M20 4BX
    9 Mid Yorkshire Hospitals NHS Trust Wakefield United Kingdom WF1 4DG

    Sponsors and Collaborators

    • The Christie NHS Foundation Trust
    • Celgene Corporation
    • Leukemia Research Fund

    Investigators

    • Principal Investigator: Adrian Bloor, The Christie NHS Foundation Trust

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01127542
    Other Study ID Numbers:
    • 09_DOG06_99
    • 2009-011078-14
    • ISRCTN
    First Posted:
    May 21, 2010
    Last Update Posted:
    Dec 5, 2011
    Last Verified:
    Dec 1, 2011
    Additional relevant MeSH terms:
    Leukemia
    Leukemia, Lymphoid
    Leukemia, Lymphocytic, Chronic, B-Cell
    Lenalidomide

    Study Results

    No Results Posted as of Dec 5, 2011