Diffuse Large B-cell LymphomaPhase 2NCT02542111
A Study of Bortezomib Plus GDP in the Treatment of Refractory and Relapsed Non-GCB DLBCL
A Phase 2 study testing Bortezomib, Gemcitabine and Dexamethasone in people with Diffuse Large B-cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of non-GCB DLBCL patients. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Bortezomib, Gemcitabine and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- May 2015to May 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
- No history of stem cell transplantation, and no intention for stem cell transplantation.
- Age between 16-75.
- ECOG<3.
- At least 1 measurable tumor mass.
- Minimum life expectancy of 3 months.
- Written informed consent.
- 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.
Who cannot join
- Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- Clinically significant active infection.
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
- Patients who are pregnant or breast-feeding.
- HIV infection.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality
Pengpeng XU, MD, 64370045 ext. 610707
About this study
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
This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of non-GCB DLBCL patients.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Bortezomib, Gemcitabine, Dexamethasone, Cisplatin
- Keywords
- diffuse large b-cell lymphoma
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BortezomibDrug
Bortezomib IV
GemcitabineDrug
Gemcitabine IV
DexamethasoneDrug
Dexamethasone IV
CisplatinDrug
Cisplatin IV
| Study group | Role | What they receive |
|---|---|---|
| V-GDP | Experimental | 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 Receives: Drug: Bortezomib; Drug: Gemcitabine; Drug: Dexamethasone; Drug: Cisplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
28 days as one cycle
Measured: Every 2 cycles during treatment and then every 3 months for 2 years
Secondary outcomes (3)
Progression free survival
Measured: 1 year
Overall survival
Measured: 1 year
Safety as assessed using the CTCAE
28 days as one cycle
Measured: Days 1 of each course and 4-6 weeks after final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startMay 2015
- Primary completionMay 2018 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhao Weili, Ruijin Hospital
- Investigators
- Weili Zhao, Prof, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02542111
- Sponsor's protocol ID
- V-GDP
- Status last verified
- Nov 2017
- First submitted
- 24 Aug 2015
- Last updated
- 14 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02542111
- Acronym / sponsor ID
- V-GDP
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- diffuse large b-cell lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- May 2015
- Primary completion
- May 2018 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 4 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the efficacy and safety of Bortezomib plus GDP in the treatment of non-GCB DLBCL patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| V-GDP | Experimental | Drug: Bortezomib, Drug: Gemcitabine, Drug: Dexamethasone, Drug: CisplatinBortezomib 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 |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
- No history of stem cell transplantation, and no intention for stem cell transplantation.
- Age between 16-75.
- ECOG<3.
- At least 1 measurable tumor mass.
Key exclusion criteria (7 listed)
- Chemotherapy or large field radiotherapy within 3 weeks prior to entering the study.
- Clinically significant active infection.
- Impaired liver, renal or other organ function not caused by lymphoma, which will interfere with the treatment schedule.
- Any significant medical or psychiatric condition that might prevent the patient from complying with all study procedures.
- Subject has ≥grade 2 peripheral neuropathy or grade 1 with pain within 14 days before enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BortezomibBortezomib IV | Drug | V-GDP |
| GemcitabineGemcitabine IV | Drug | V-GDP |
| DexamethasoneDexamethasone IV | Drug | V-GDP |
| CisplatinCisplatin IV | Drug | V-GDP |
Primary outcome
Response rate
Time frame: Every 2 cycles during treatment and then every 3 months for 2 years
28 days as one cycle
3 secondary outcomes
Progression free survival
Time frame: 1 year
Overall survival
Time frame: 1 year
Safety as assessed using the CTCAE
Time frame: Days 1 of each course and 4-6 weeks after final treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weili Zhao, Prof principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Bortezomib, Gemcitabine and Dexamethasone in people with Diffuse Large B-cell Lymphoma, run by Ruijin Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weili Zhao, Prof (64370045 ext. 610707, zhao.weili@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: Every 2 cycles during treatment and then every 3 months for 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2017.