Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2025-12-24 @ 3:49 PM
NCT ID:
NCT01354392
Eligibility Criteria:
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 criteria.
* 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 study.
* 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 assistance.
* 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 laboratory.
* 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 hysterectomy).
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01354392
Study Brief:
Protocol Section:
NCT01354392