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

Diffuse Large B-cell Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02542111
• Other study ID #: V-GDP
• Status: Recruiting
• Phase: Phase 2
• First received: August 24, 2015
• Last updated: November 10, 2017
• Start date: May 2015
• Est. completion date: May 2018

Study information

• Verified date: November 2017
• Source: Ruijin Hospital
• Contact: Weili Zhao, Prof
• Phone: 64370045
• Email: zhao.weili[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diffuse Large B-cell Lymphoma
• Lymphoma
• Lymphoma, B-Cell
• Lymphoma, Large B-Cell, Diffuse

Intervention

Drug:
• Bortezomib
Bortezomib IV
• Gemcitabine
Gemcitabine IV
• Dexamethasone
Dexamethasone IV
• Cisplatin
Cisplatin IV

Locations

Country	Name	City	State
China	Ruijin Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ruijin Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate	28 days as one cycle	Every 2 cycles during treatment and then every 3 months for 2 years
Secondary	Progression free survival		1 year
Secondary	Overall survival		1 year
Secondary	Safety as assessed using the CTCAE	28 days as one cycle	Days 1 of each course and 4-6 weeks after final treatment