An evaluation of therapy for B-cell lymphoma with Bortezomib

Phase 3

• Conditions: Diffuse large B-cell lymphoma; Cancer

• Registration Number: ISRCTN51837425
• Lead Sponsor: Southampton University Hospitals NHS Trust (UK)

Brief Summary

2019 results in https://www.ncbi.nlm.nih.gov/pubmed/30948276 (added 24/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-30
• Last Update Posted: 13 May 2019
• Study Completion: 2020-04-12

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 1128

Inclusion Criteria

1. Histologically confirmed Diffuse large B-cell lymphoma (DLBCL), expressing CD20
2. Sufficient diagnostic material should be available to forward to Haematological Malignancy Diagnostic Service (HDMS) for gene expression profiling and central pathology review
3. Core biopsies are acceptable, however the molecular profiling success rate is inferior compared to larger surgically acquired tissue samples
4. Best diagnostic practice encourages investigators to seek the latter approach whenever clinically appropriate
5. Not previously treated for lymphoma and fit enough to receive combination chemoimmunotherapy with curative intent
6. Age >18 years
7. Stage IAX (bulk defined as lymph node diameter >10cm) to stage IV disease and deemed to require a full course of chemotherapy
8. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
9. Adequate bone marrow function with platelets >100x109/L; neutrophils >1.0x109/L at study entry, unless lower figures are attributable to lymphoma
10. Serum creatinine <150µmol/L, measured or calculated creatinine clearance >30mls/min, serum bilirubin <35µmol/L and transaminases <2.5x upper limit of normal at the time of study entry, unless attributable to lymphoma
11. Cardiac function sufficient to tolerate 300mg/m2 of doxorubicin
12. A pre-treatment echocardiogram is not mandated, but recommended in patients considered at higher risk of anthracycline cardiotoxicity
13. No concurrent uncontrolled medical condition
14. Life expectancy >3 months
15. Adequate contraceptive precautions for all patients of child bearing potential
16. A negative serum pregnancy test for females of child bearing potential or those <2 years after the onset of the menopause
17. Patients will have provided written informed consent
18. Target gender: male and female
19. Lower age limit 18 years

Exclusion Criteria

1. Previous history of treated or untreated indolent lymphoma, however newly diagnosed patients with DLBCL who are found to also have small cell infiltration of the bone marrow or other diagnostic material (discordant lymphoma) will be eligible.
2. Uncontrolled systemic infection
3. History of cardiac failure of uncontrolled angina
4. Clinical CNS involvement
5. Serological positivity for Hepatitis C, B or known HIV infection. Viral serological testing is not mandated for study entry, but considered standard of care. Patients who are HepBsAg positive will not be eligible.
6. Serious medical or psychiatric illness likely to affect participation or that may compromise the ability to give informed consent
7. Active malignancy other than fully excised squamous or basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix in the preceding 5 years
8. History of allergic reaction to substances containing boron or mannitol
9. Patient unwilling to abstain from green tea and preparations made from green tea as bortezomib may interact with these
10. Any co-existing medical or psychological condition that would compromise ability to give informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified