A phase 2 trial of AZD1152 in relapsed/refractory diffuse large B-cell lymphoma - AZD1152 in diffuse large B-cell lymphoma
- Conditions
- 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)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2010-022812-37-GB
- Lead Sponsor
- Oxford University Hospitals NHS Trust
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 15
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method