Diffuse Large B-cell Lymphoma (DLBCL) MedDRA version: 14.1 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Product Name: AZD1152
Product Code: AZD1152
Pharmaceutical Form: Powder and solvent for solution for infusion
INN or Proposed INN: AZD1152 hydroxy-quina
Sponsors
Oxford University Hospitals NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A participant will be eligible for inclusion in this study if all of the following criteria apply: 1. Male or Female, aged = 18 years. 2. ECOG performance score of 0, 1 or 2. 3. Life expectancy of at least 12 weeks. 4. Haematological and biochemical indices within the ranges shown below. Lab Test Value required Haemoglobin (Hb) = 9g/dL White Blood Count (WBC) = 2x10^9/L Platelet count = 100x10^9/L Absolute Neutrophil count = 1.0x10^9/L Serum bilirubin = 1.5 x ULN AST (SGOT) or ALT = 2.5 x ULN Creatinine clearance (Cockcroft-Gault) > 50 ml/min 5. 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. 6. Relapsed or refractory DLBCL proven by biopsy (within 6 months of enrollment in trial); either de novo DLBCL or transformed low grade lymphoma. 7. At least 1 lesion (> 1.5cm), not previously irradiated, that can be accurately measured on CT and which is FDG avid on PET-CT scanning, as defined by Cheson criteria. 8. Able to give an informed consent and be capable of co-operating with the protocol. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: A participant will not be eligible for the trial if any of the following apply: 1. Any anti-cancer therapy (including radiotherapy and participation in other clinical trials) within 28 days prior to Day 1. (see protocol for full detail on steroid use). 2. Any unresolved toxicity from prior anti-cancer therapy, which is greater than CTCAE grade I (except alopecia). 3. Previous treatment with aurora kinase inhibitors. 4. Clinical evidence of central nervous system involvement. 5. 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. 6. 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. 7. 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. 8. Mean QTc interval = 470 ms calculated from 3 ECGs using Fridericia’s or Bazett’s correction. 9. Serologically positive for HIV, hepatitis B or C assessed within 28 days of initiation of study treatment. 10. Participants of reproductive potential not willing to use adequate contraceptive measures for the duration of the study (both male and female participants). 11. 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). 12. Participants who have had live attenuated or yellow fever vaccines within 6 months of trial beginning. 13. Participants not willing and able to comply with the protocol for the duration of the study, and scheduled follow-up visits and examinations.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether AZD1152 is an active anti-lymphoma agent in patients with the commonest type of aggressive lymphoma (DLBCL).; Secondary Objective: To assess the number of patients who have not relapsed or died over a 1 year period after treatment with AZD1152. Look for changes in tumour size as a result of treatment To assess how safe AZD1152 is in patients with this type of lymphoma and to determine the side effects associated with its use. ;Primary end point(s): Overall response rate (ORR; Cheson 2007 criteria) | — |
Countries
United Kingdom
Outcome results
None listed