A Study of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB DLBCL

A Phase II Study of the Efficacy and Safety of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB Diffuse Large B-cell Lymphoma

This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of non-GCB DLBCL patients.

Inclusion Criteria:

1. Histologically proven diffuse large B-cell lymphoma non-GCB subtype. Previously treated with 1, and only 1, chemotherapy regimen including an anthracycline and excluding cisplatin, cytarabine, bortezomib and gemcitabine. Relapse after CR, less than PR or PR to previous treatment.
2. No history of stem cell transplantation, and no intention for stem cell transplantation.
3. Age between 16-75.
4. ECOG<3.
5. At least 1 measurable tumor mass.
6. Minimum life expectancy of 3 months.
7. Written informed consent.
8. No uncontrolled CNS involvement by lymphoma:No CNS disease at time of relapse;CNS disease diagnosed at initial presentation allowed provided a complete response for CNS disease was achieved and maintained.

Exclusion Criteria:

1. Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
2. Clinically significant active infection.
3. Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
4. Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
5. Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
6. Patients who are pregnant or breast-feeding.
7. HIV infection.