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A Phase 2 Trial of AZD1152 in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Phase 1/Phase 2
18 Years
Open (Enrolling)

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Trial Information

A Phase 2 Trial of AZD1152 in Relapsed/Refractory Diffuse Large B-cell Lymphoma

Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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
(except alopecia).

- 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
trial beginning.

- Participants not willing and able to comply with the protocol for the duration of the
study, and scheduled follow-up visits and examinations.

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate (ORR; Cheson 2007 criteria)

Outcome Time Frame:

ORR will be calculated from the data obtained from the End Visit, which occurs approx. 14 days after the end of the last cycle of treatment the patient undergoes.

Safety Issue:


Principal Investigator

Chris Hatton, MRCPath FRCPath(UK) MRCP FRCP

Investigator Role:

Study Director

Investigator Affiliation:

Oxford Radcliffe NHS Trust & University of Oxford


United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

September 2011

Completion Date:

September 2014

Related Keywords:

  • Lymphoma
  • Relapsed or refractory
  • Large B-Cell
  • Diffuse
  • Lymphoma
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse