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This Phase 1 study examines the feasibility of adding bortezomib to R-ICE chemotherapy (rituximab, ifosfamide, etoposide, carboplatin) in patients with relapsed or refractory diffuse large B-cell lymphoma. It included patients aged 21-70 who had previously received anthracycline- and rituximab-containing treatment. It was carried out in Phase 1 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: 1. Histologically proven diffuse large B-cell lymphoma in first relapse after CR, less than PR or PR to first line treatment De Novo DLBCL, DLBCL arising from transformed follicular lymphoma or chronic lymphocytic leukaemia are allowed. Prior rituximab is allowed Prior radiation is allowed Prior autologous stem cell transplant is allowed CD20 negative relapses are allowed 2. Age between 21-70 3. Written informed consent 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 5. Minimum life expectancy of 3 months 6. Previously treated with chemotherapy containing anthracyclines and rituximab 7. Negative urine or serum pregnancy test on females of childbearing potential 8. Female subject is either post-menopausal or surgically sterilized or willing to use an acceptable method of birth control (i.e., a hormonal contraceptive, intra-uterine device, diaphragm with spermicide, condom with spermicide, or abstinence) for the duration of the study. 9. Male subject agrees to use an acceptable method for contraception for the duration of the study. 10. No CNS involvement 11. Measurable disease on CT scan by international working group response criteria Exclusion Criteria: 1. Prior allogeneic transplantation 2. Prior treatment with bortezomib 3. Concomitant use of any other anti-cancer therapy 4. Concomitant use of any other investigational agent 5. Known infection with human immunodeficiency virus (HIV) 6. Patient has known clinically active hepatitis B (carriers of hepatitis B are permitted to enter the study) 7. Contraindication to any drug contained in chemotherapy regimens 8. Not previously treated with anthracycline-containing regimens 9. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule 10. Poor bone marrow reserve (neutrophils \<1.0 x 109/L or platelets \<75 x 10(9)/L unless related to bone marrow infiltration 11. Subject has a calculated or measured creatinine clearance of \<20 mL/minute within 14 days before enrollment. 12. Myocardial infarction within 6 months prior to enrollment or has New York Hospital Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities. Prior to study entry, any ECG abnormality at Screening has to be documented by the investigator as not medically relevant. 13. Clinically significant active infection 14. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment. 15. Patients who are pregnant or breast-feeding 16. Coexistent second malignancy or history of prior malignancy within previous 3 years (excluding non-melanoma skin tumors or in situ carcinoma of the cervix) 17. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.