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

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02542111

Enrollment

Registered

2015-09-04

Start date

2015-05-31

Completion date

2018-05-31

Last updated

2017-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Large B-cell Lymphoma

Keywords

diffuse large b-cell lymphoma

Brief summary

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

Interventions

DRUGBortezomib

Bortezomib IV

DRUGGemcitabine

Gemcitabine IV

DRUGDexamethasone

Dexamethasone IV

DRUGCisplatin

Cisplatin IV

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Response rate	Every 2 cycles during treatment and then every 3 months for 2 years	28 days as one cycle

Secondary

Measure	Time frame	Description
Progression free survival	1 year	—
Overall survival	1 year	—
Safety as assessed using the CTCAE	Days 1 of each course and 4-6 weeks after final treatment	28 days as one cycle

Countries

China

Contacts

Primary ContactWeili Zhao, Prof

zhao.weili@yahoo.com64370045

Backup ContactPengpeng XU, MD

xpproc@msn.com64370045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026