Diffuse Large B-cell LymphomaPhase 4NCT02752815
Reduced Chemotherapy in Low Risk DLBCL
A Phase 4 study testing Rituximab, Cyclophosphamide and Epirubicin in people with Diffuse Large B-cell Lymphoma, run by Ruijin Hospital at 1 site in China.
Trial summary
This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma. Read more about this study
- Who is it for?
- Ages 14 to 75 years
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- What is being tested?
- Rituximab, Cyclophosphamide and Epirubicin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2016to 31 Dec 2024
- 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 14 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21
- Age>=14 y.o.,<=75 y.o.
- IPI=0-1
- non-bulky (largest diameter <7.5cm)
- ECOG =0-1
- Life expectancy>6 months
- Informed consented
Who cannot join
- Chemotherapy before
- Stem cell transplantation before
- History of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary cutaneous, CNS DLBCL
- LVEF≤50%
Show all 12Show fewer
- Other uncontrollable medical condition that may that may interfere the participation of the study
- Lab at enrollment(unless caused by lymphoma) Neutrophile<1.5*10^9/L Platelet<80*10^9/L Hemoglobulin<100g/L ALT or AST >2*ULN,AKP or bilirubin >1.5*ULN Creatinine>1.5*ULN
- Not able to comply to the protocol for mental or other unknown reasons
- Pregnant or lactation
- If HbsAg positive, should check HBV DNA, DNA positive patients cannot be enrolled. If HBsAg negative but HBcAb positive (whatever HBsAb status), should check HBV DNA,DNA positive patients cannot be enrolled.
- HIV infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma.
This is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.
- Conditions
- Diffuse Large B-cell Lymphoma
- Being tested
- Rituximab, Cyclophosphamide, Epirubicin, Vincristine, Prednisone
- 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.
RituximabDrug
CyclophosphamideDrug
EpirubicinDrug
VincristineDrug
PrednisoneDrug
| Study group | Role | What they receive |
|---|---|---|
| 6R-CHOP+2R | Active comparator | 6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone |
| 4R-CHOP+4R | Experimental | 4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days
2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Epirubicin; Drug: Vincristine; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression free survival
Measured: 2-year
Secondary outcomes (3)
Overall survival
Measured: 2-year
Complete Response rate
Measured: 21 days after 8 cycles of treatment（each cycle is 21 days）
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Measured: Each cycle of treatment（each cycle is 21 days）and then every 3 months for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2016 (estimated)
- Study start14 Jun 2016
- Primary completion30 Oct 2022
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 290 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, MD, PhD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02752815
- Sponsor's protocol ID
- NHL-006
- Status last verified
- Dec 2022
- First submitted
- 20 Apr 2016
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Shi Q, He Y, Yi HM, Mu RJ, Jiang XF, Fu D, Dong L, Qin W, Xu PP, Cheng S, Song Q, Chen SJ, Wang L, Zhao WL. Positron emission tomography-adapted therapy in low-risk diffuse large B-cell lymphoma: results of a randomized, phase III, non-inferiority trial. Cancer Commun (Lond). 2023 Aug;43(8):896-908. doi: 10.1002/cac2.12462. Epub 2023 Jul 4.
PubMed 37403255
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Four Cycles of R-CHOP Followed by Four Cycles of Rituximab Versus Six Cycles of R-CHOP Followed by Two Cycles of Rituximab in the Treatment of de Novo, Low-risk, Non-bulky Diffuse Large B-cell Lymphoma.
- ClinicalTrials.gov ID
- NCT02752815
- Acronym / sponsor ID
- NHL-006
- Conditions
- Diffuse Large B-cell Lymphoma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 14 Jun 2016 (actual)
- Primary completion
- 30 Oct 2022 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 27 Apr 2016 (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 is a clinical trial to compare the efficacy and safety of four cycles of R-CHOP followed by four cycles of Rituximab with six cycles of R-CHOP followed by two cycles of Rituximab in the treatment of de novo, low-risk, non-bulky diffuse large B-cell lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 6R-CHOP+2R | Active comparator | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Epirubicin, Drug: Vincristine, Drug: Prednisone6 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days |
| 4R-CHOP+4R | Experimental | Drug: Rituximab, Drug: Cyclophosphamide, Drug: Epirubicin, Drug: Vincristine, Drug: Prednisone4 cycles of R-CHOP Rituximab 375 mg/m2 IV d1 Cyclophosphamide 750mg/m2 IV d2 Epirubicin 70mg/m2 IV d2 Vincristine 1.4 mg/m2 IV d2 Prednisone 60 mg/m2 PO d2-6 Frequency 21days 2 cycles of Rituximab monotherapy Rituximab 375 mg/m2 IV d1 Frequency 21days |
Who may qualify
- Ages
- 14 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Histologically confirmed de novo diffuse large B-cell lymphoma, complete response after 4 cycles of standard R-CHOP21
- Age>=14 y.o.,<=75 y.o.
- IPI=0-1
- non-bulky (largest diameter <7.5cm)
- ECOG =0-1
Key exclusion criteria (12 listed)
- Chemotherapy before
- Stem cell transplantation before
- History of malignancy, except for basal cell or squamous cell carcinoma of the skin or carcinoma in situ of the cervix
- Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
- Primary cutaneous, CNS DLBCL
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 |
|---|---|---|
| Rituximab | Drug | 4R-CHOP+4R, 6R-CHOP+2R |
| Cyclophosphamide | Drug | 4R-CHOP+4R, 6R-CHOP+2R |
| Epirubicin | Drug | 4R-CHOP+4R, 6R-CHOP+2R |
| Vincristine | Drug | 4R-CHOP+4R, 6R-CHOP+2R |
| Prednisone | Drug | 4R-CHOP+4R, 6R-CHOP+2R |
Primary outcome
Progression free survival
Time frame: 2-year
3 secondary outcomes
Overall survival
Time frame: 2-year
Complete Response rate
Time frame: 21 days after 8 cycles of treatment（each cycle is 21 days）
Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0
Time frame: Each cycle of treatment（each cycle is 21 days）and then every 3 months for 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2022.
- Derived from this study: PubMed 37403255Shi Q, He Y, Yi HM, Mu RJ, Jiang XF, Fu D, Dong L, Qin W, Xu PP, Cheng S, Song Q, Chen SJ, Wang L, Zhao WL. Positron emission tomography-adapted therapy in low-risk diffuse large B-cell lymphoma: results of a randomized, phase III, non-inferiority trial. Cancer Commun (Lond). 2023 Aug;43(8):896-908. doi: 10.1002/cac2.12462. Epub 2023 Jul 4.
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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, MD, PhD 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 4 study testing Rituximab, Cyclophosphamide and Epirubicin 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 7 inclusion and 12 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 5 Dec 2022. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression free survival (time frame: 2-year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02752815, which also lists 1 linked publication.
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 5 Dec 2022.