Diffuse Large B Cell LymphomaPhase 4NCT03513601
Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma
A Phase 4 study testing (R)-CHOP regimen and (R)-CVP regimen in people with Diffuse Large B Cell Lymphoma, run by Mingzhi Zhang at 1 site in China.
Trial summary
To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age. Read more about this study
- Who is it for?
- Ages 70 to 85 years
- Conditions the study is for
- Diffuse Large B Cell Lymphoma
- What is being tested?
- (R)-CHOP regimen and (R)-CVP regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2017to May 2019
- Phase
- Phase 4
- 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 70 to 85 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Above 70 years old，Pathology proved to be diffuse large B cell lymphoma，Estimated survival time > 3 months，None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- volunteers who signed informed consent.
Who cannot join
- Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Oncology Department of The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Mingzhi Zhang, Pro,Dr, 13838565629, mingzhi_zhang@126.com
About this study
To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.
Read the detailed description
The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.
- Conditions
- Diffuse Large B Cell Lymphoma
- Being tested
- (R)-CHOP regimen, (R)-CVP regimen
- Keywords
- Curative effect evaluation, Adverse reactions, Clinical characteristics, PR, PFS, OS
- 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.
(R)-CHOP regimenDrug
Also called (rituximab)，CTX，VCR，EPI，PDN
(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles.
(R)-CVP regimenDrug
Also called (rituximab)，CTX，VCR，PDN,20 percent reduction in chemical therapy
The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide .
| Study group | Role | What they receive |
|---|---|---|
| (R)-CHOP regimen | Experimental | (R)-CHOP regimen((rituximab)，cyclophosphamide，epirubicin，vincristine and prednisone)，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles. Receives: Drug: (R)-CHOP regimen |
| (R)-CVP regimen | Experimental | (R)-CVP regimen((rituximab)，cyclophosphamide，vincristine and prednisone) The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide . Receives: Drug: (R)-CVP regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Progression-free survival
Measured: up to end of follow-up-phase(approximately 24 months)
Secondary outcomes (3)
overall survival
overall survival
Measured: up to the date of death (approximately 5 years)
disease control rate
disease control rate
Measured: every 6 weeks,up to completion of treatment(approximately 18 weeks )]
objective remission rate
objective remission rate
Measured: every 6 weeks,up to completion of treatment(approximately 18 weeks )]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2018
- Study start1 Jul 2017
- Primary completionMay 2019 (estimated)
- Study completionMay 2019 (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.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mingzhi Zhang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mingzhi Zhang, Zhengzhou University
- Investigators
- Mingzhi zhang, Principal investigator, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03513601
- Sponsor's protocol ID
- hnslblzlzx2017-10
- Status last verified
- Apr 2018
- First submitted
- 31 Oct 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT03513601
- Acronym / sponsor ID
- hnslblzlzx2017-10
- Conditions
- Diffuse Large B Cell Lymphoma
- Keywords
- Curative effect evaluation, Adverse reactions, Clinical characteristics, PR, PFS, OS
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mingzhi ZhangUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2019 (estimated)
- First posted
- 1 May 2018 (actual)
- 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.
To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.
Detailed description
The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (R)-CHOP regimen | Experimental | Drug: (R)-CHOP regimen(R)-CHOP regimen((rituximab)，cyclophosphamide，epirubicin，vincristine and prednisone)，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles. |
| (R)-CVP regimen | Experimental | Drug: (R)-CVP regimen(R)-CVP regimen((rituximab)，cyclophosphamide，vincristine and prednisone) The dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide . |
Who may qualify
- Ages
- 70 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Above 70 years old，Pathology proved to be diffuse large B cell lymphoma，Estimated survival time > 3 months，None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.
- volunteers who signed informed consent.
Key exclusion criteria (1 listed)
- Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.
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 |
|---|---|---|
| (R)-CHOP regimenAlso: (rituximab)，CTX，VCR，EPI，PDN(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,epirubicin 50mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and six cycles are required. Efficacy was evaluated every two cycles. | Drug | (R)-CHOP regimen |
| (R)-CVP regimenAlso: (rituximab)，CTX，VCR，PDN,20 percent reduction in chemical therapyThe dose of the chemical was reduced by 20%，(rituximab 375mg/m2 d0 ivgtt),cyclophosphamide 750mg/m2 d1、8 ivgtt,vincristine 2mg d1、8 ivgtt,prednisone 60mg d1-5 po.Every 21 days for one cycle and one or two cycles are required. Efficacy was evaluated every two cycles. Subsequent (rituximab 375mg/m2 d0 ivgtt)， oral cyclophosphamide . | Drug | (R)-CVP regimen |
Primary outcome
Progression-free survival
Time frame: up to end of follow-up-phase(approximately 24 months)
Progression-free survival
3 secondary outcomes
overall survival
Time frame: up to the date of death (approximately 5 years)
disease control rate
Time frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )]
objective remission rate
Time frame: every 6 weeks,up to completion of treatment(approximately 18 weeks )]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2018.
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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.
Mingzhi zhang principal investigator
The First Affiliated Hospital of Zhengzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing (R)-CHOP regimen and (R)-CVP regimen in people with Diffuse Large B Cell Lymphoma, run by Mingzhi Zhang 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 2 inclusion and 1 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 1 May 2018. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Mingzhi zhang, Pro,Dr (13838565629, Mingzhi_zhang@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: up to end of follow-up-phase(approximately 24 months)). 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 1 May 2018.