CLL210 (OfaDexRev)

Trial Overview

A Phase II Trial of Ofatumumab, Dexamethasone and Lenalidomide Followed by Randomisation to Lenalidomide Maintenance Versus No Further Treatment for High-Risk CLL.

Inclusion criteria

CLL/SLL requiring treatment by IWCLL 2008 criteria. At least one of the following criteria should be met:

  1. Evidence of progressive marrow failure as manifested by the development of, or worsening of, anaemia and/or thrombocytopenia
  2. Massive (i.e. at least 6cm below the left costal margin) or progressive or symptomatic splenomegaly
  3. Massive (i.e. at least 10cm in longest diameter) or progressive or symptomatic lymphadenopathy
  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 30×109/l and not due to causes other than CLL.
  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.


High risk CLL/SLL defined by at least one of the following criteria:

  1. TP53 deletion or mutation affecting at least 20% of CLL cells
  2. Resistant (SD/PD) to fludarabine-containing combination therapy Relapse within 12 months of responding to fludarabine-containing combination therapy
  3. No prior treatment with ofatumumab or lenalidomide


CLL not known to be resistant to glucocorticoids

  1. No more than 3 previous treatment episodes for CLL (excluding chlorambucil-based regimens)
  2. WHO performance status 0-2
  3. Aged at least 18 years
  4. Written Informed Consent


Exclusion criteria

  1. Neutrophil count less than 0.5×109/l or platelet count less than 25×109/l
  2. Uncontrolled auto-immune haemolytic anaemia or thrombocytopenia
  3. Total bilirubin >1.5 times upper normal limit (unless due to involvement of liver or a known history of Gilbert’s disease) or ALT >2.5 times upper normal limit (unless due to disease involvement of liver)
  4. Active infection
  5. Active gastritis or peptic ulcer disease
  6. Uncontrolled diabetes mellitus or hypertension
  7. History of recurrent thromboembolism
  8. Seropositivity for HIV, HCV or HBV (surface antigen and core antibody)*
  9. Renal impairment (eGFR less than 30ml/min)
  10. Concurrent treatment with glucocorticoids equivalent to more than prednisolone 20mg od
  11. Presence or history of CNS disease (either CNS lymphoma or leukaemic meningitis)
  12. History of Richter transformation
  13. Concomitant malignancies except adequately treated localised non-melanoma skin cancers and other in-situ cancers, or invasive cancers that have been in remission for a period of time considered by the local investigator to pose a negligible risk of relapse during the period of the trial.
  14. Major surgery within 28 days prior to registration
  15. 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
  16. Treatment within a clinical trial within 30 days prior to trial entry
  17. Adult patient under tutelage (not competent to sign informed consent)
  18. Pregnant or lactating women
  19. Patients unwilling or not able to adhere to the Lenalidomide Pregnancy Prevention Plan Women taking the oral contraceptive pill within 4 weeks of study registration owing to an increased risk of thromboembolism (see section 8.2.6)
  20. Women of childbearing potential, including women whose last menstrual period was less than one year prior to screening, unable or unwilling to use adequate contraception from study start to one year after the last dose of protocol therapy. Adequate contraception is defined as hormonal birth control, intrauterine device, double barrier method or total abstinence. Male subjects unable or unwilling to use adequate contraception methods from study start to one year after the last dose of protocol therapy


*In the case of hepatitis B, positivity for surface antigen (HBsAg) indicates active infection and these patients are excluded from the study. HBsAg-negative patients who test positive for core antibody (HBcAb) should be re-tested for HBcAb using a different method to exclude a false-positive result. Patients who are positive for HBcAb by one method and negative by another are very unlikely to have hepatitis B infection and are eligible for the study. Patients who are positive for HBcAb by two separate methods may or may not have active hepatitis B infection and should be further tested for hepatitis B surface antibody (HBsAb). Those patients who are positive (in excess of 100 IU/L) for HBsAb (HBsAg-/HbcAb+/HBsAb+) are very unlikely to have hepatitis B infection and are eligible for the study, whereas those who are negative (HBsAg-/HBcAb+/HBsAb-) could have occult hepatitis B infection and should be excluded from the study.


Principal Investigator

Peter Hillmen

Tel: 0113 2068513

E-mail: [email protected]

Research Nurse

David Buchanan

Tel: 0113 2067436

E-mail: [email protected]

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