- Male or Female, aged ≥ 18 yrs.
- ECOG performance score of 0, 1 or 2.
- Life expectancy of at least 12 weeks.
- Haematological and biochemical indices within the ranges shown below Lab Test
Value required Haemoglobin (Hb) ≥ 9g/dL White Blood Count (WBC) ≥
2x109/L Platelet count ≥ 100x109/L Absolute Neutrophil count ≥
1.0x109/L; Serum bilirubin ≤ 1.5 x ULN AST (SGOT) or ALT ≤ 1.5 x ULN
Creatinine clearance (Cockcroft-Gault) > 50 ml/min
- Relapsed or refractory DLBCL in which all participants must have received at least
one potentially curative established immunochemotherapy lymphoma regimen that
contained rituximab (e.g. R-CHOP, R-PMitCEBO, R-GCVP, R-CNOP). Participants must also
have failed or be ineligible for salvage/high dose therapy.
- Relapsed or refractory DLBCL proven by biopsy (within 6 months of enrolment in
trial); either de novo DLBCL or transformed follicular lymphoma.
- At least 1 lesion (> 1.5cm), not previously irradiated, that can be accurately
measured on CT and which is FDG avid on CT-PET scanning, as defined by Cheson
- Able to give informed consent and capable of co-operating with protocol.
- Any anti-cancer therapy (including radiotherapy and participation in other clinical
trials) within 28 days prior to Day 1. Patients may however be receiving
corticosteroids as an anti-lymphoma treatment of 50mg daily prednisolone or
equivalent up until screening. At screening (or before) this must be tapered down so
that they are only on a low dose (10mg daily or less) by the time AZD1152 commences.
This may be continued for indications other than lymphoma treatment throughout the
- Any unresolved toxicity from prior anti-cancer therapy greater than CTCAE grade I
- Previous treatment with aurora kinase inhibitors.
- Clinical evidence of central nervous system involvement.
- Another active malignancy within the past five years, except adequately treated basal
or squamous cell carcinoma of the skin, or carcinoma of the cervix in situ.
- Clinically significant and uncontrolled major medical condition(s) including but not
limited to: active infection, bleeding diathesis, symptomatic congestive heart
failure, cardiac arrhythmia or psychiatric illness/social situations which would
limit compliance with protocol requirements.
- Major surgery within 4 weeks prior to entry into the study (excluding placement of
vascular access or biopsy) that involved general anaesthesia or respiratory
- Mean QTc interval > 470 ms calculated from 3 ECGs using Fridericia's or Bazett's
correction on 12-lead ECG machine.
- Serologically positive for HIV, hepatitis B or C assessed within 28 days of
initiation of study treatment using an ELISA method performed by an HPA accredited
- Participants of reproductive potential not willing to use adequate contraceptive
measures for the duration of the study (both male and female participants).
- Pregnant or breastfeeding women. Female participants must have a negative urinary or
serum pregnancy test when done or have evidence of post-menopausal status (Defined as
absence of menstruation for greater than 12 months, bilateral oophorectomy or
- Participants who have had live attenuated or yellow fever vaccines within 6 months of
- Participants not willing and able to comply with the protocol for the duration of the
study, and scheduled follow-up visits and examinations.