Phase II trial of alemtuzumab, dexamethasone and lenalidomide followed by randomisation to lenalidomide maintenance versus no further treatment for high-risk CLL NCRI CLL210)
- Conditions
- eukaemiaCancerLeukaemia, unspecified
- Registration Number
- ISRCTN40303610
- Lead Sponsor
- niversity of Liverpool (UK)
- Brief Summary
2017 Abstract results in https://livrepository.liverpool.ac.uk/3006822/ results 2020 Results article in https://www.ncbi.nlm.nih.gov/pubmed/32054653 results (added 17/02/2020)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 64
1. CLL/SLL requiring treatment by IWCLL 2008 criteria
2. At least one of the following criteria should be met:
2.1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia
2.2. Massive (i.e. at least 6cm below the left costal margin) or progressive or symptomatic splenomegaly
2.3. Massive (i.e. at least 10cm in longest diameter) or progressive or symptomatic lymphadenopathy
2.4. Progressive lymphocytosis with an increase of more than 50% over a 2-month period or lymphocyte doubling time (LDT) of less than 6 months from a baseline value of at least 30x109/l and not due to causes other than CLL.
2.5. Constitutional symptoms defined as at least 10% unintentional weight loss within the previous 6 months, significant fatigue preventing usual activities, or fever of at least 38°C for at least 2 weeks or night sweats for at least one month in the absence of infection
3. High risk CLL/SLL defined by at least one of the following criteria:
3.1. TP53 deletion or mutation affecting at least 20% of CLL cells
3.2. Resistant (SD/PD) to fludarabine-containing combination therapy
3.3. Relapse within 12 months of responding to fludarabine-containing combination therapy
3.4. No prior treatment with alemtuzumab or lenalidomide
4. CLL not known to be resistant to glucocorticoids
5. No more than 3 previous treatment episodes for CLL
6. WHO performance status 0-2
7. Aged at least 18 years
8. Written informed consent
9. Male and female participants
10.Lower age limit 18 years, no age limit
1. Neutrophil count less than 0.5x109/l or platelet count less than 25x109/l
2. Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
3. Active infection
4. Active gastritis or peptic ulcer disease
5. Uncontrolled diabetes mellitus or hypertension
6. History of recurrent thromboembolism
7. Seropositivity for HIV, HCV or HBV (surface antigen or core antibody)
8. Renal impairment (creatinine clearance less than 30ml/min)
9. Hepatic impairment (serum bilirubin more than twice the upper limit of normal unless due to Gilbert's syndrome or CLL)
10. Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg
11. Presence or history of CNS disease (either CNS lymphoma or leukaemic meningitis) 12. History of Richter transformation
13. Allergy to rat proteins
14. Concomitant malignancies except adequately treated localised non-melanoma skin cancer and cancers that have been in remission for at least 5 years
15. Major surgery within 28 days prior to registration
16. Any serious underlying medical or psychological conditions, which could impair the ability of the patient to participate in the trial or compromise ability to give informed consent
17. Treatment within a clinical trial within 30 days prior to trial entry
18. Adult patient under tutelage (not competent to sign informed consent)
19. Pregnant or lactating women
20. All men or women of reproductive potential, unless using at least two contraceptive precautions, one of which must be a condom
21. Women taking the oral contraceptive pill within 4 weeks of study registration owing to an increased risk of thromboembolism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method