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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02542111
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : November 14, 2017
Information provided by (Responsible Party):
Zhao Weili, Ruijin Hospital

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

Condition or disease Intervention/treatment Phase
Diffuse Large B-cell Lymphoma Drug: Bortezomib Drug: Gemcitabine Drug: Dexamethasone Drug: Cisplatin Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : May 2015
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
Drug Information available for: Bortezomib

Arm Intervention/treatment
Experimental: V-GDP
Bortezomib 1.6 mg/m2/d iv d1 and d8 Gemcitabine 1000mg/m2/d iv d1 and d8 Dexamethasone 40mg/d iv d1-4 cisplatin 25 mg/m2 iv d2-4 Frequency every 28 days Total cycles 4
Drug: Bortezomib
Bortezomib IV

Drug: Gemcitabine
Gemcitabine IV

Drug: Dexamethasone
Dexamethasone IV

Drug: Cisplatin
Cisplatin IV

Primary Outcome Measures :
  1. Response rate [ Time Frame: Every 2 cycles during treatment and then every 3 months for 2 years ]
    28 days as one cycle

Secondary Outcome Measures :
  1. Progression free survival [ Time Frame: 1 year ]
  2. Overall survival [ Time Frame: 1 year ]
  3. Safety as assessed using the CTCAE [ Time Frame: Days 1 of each course and 4-6 weeks after final treatment ]
    28 days as one cycle

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Ages Eligible for Study:   16 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02542111

Contact: Weili Zhao, Prof 64370045 ext 610707
Contact: Pengpeng XU, MD 64370045 ext 610707

China, Shanghai
Ruijin Hospital Recruiting
Shanghai, Shanghai, China
Contact: Pengpeng XU, MD    64370045 ext 610707      
Sponsors and Collaborators
Ruijin Hospital
Principal Investigator: Weili Zhao, Prof Ruijin Hospital

Responsible Party: Zhao Weili, Professor, Ruijin Hospital Identifier: NCT02542111     History of Changes
Other Study ID Numbers: V-GDP
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: November 14, 2017
Last Verified: November 2017

Keywords provided by Zhao Weili, Ruijin Hospital:
diffuse large b-cell lymphoma

Additional relevant MeSH terms:
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Dexamethasone acetate
BB 1101
Antineoplastic Agents
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action