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Diffuse Large B-cell LymphomaPhase 3NCT01852435

R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

A Phase 3 study testing R-CEOP-70, R-CEOP-90 and R-CHOP-50 in people with Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B, run by Ruijin Hospital at 12 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients. Read more about this study

Who is it for?
Ages 16 to 80 years
What is being tested?
R-CEOP-70, R-CEOP-90 and R-CHOP-50
Could I receive a placebo?
No, everyone receives an active treatment
How many people
648 participants
Where
12 sitesChina
Study dates
May 2013to Feb 2018
Phase
Phase 3
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 80 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 or follicular lymphoma grade 3B
  • Age>=16 y.o.,<=80 y.o.
  • ECOG < 3
  • No past history of malignancy
  • Radiologically measurable disease, CT imaging in screening showing 2 or more clearly demarcated lesions with a largest diameter > 1.5 cm, or 1 clearly demarcated lesion with a largest diameter > 2.0 cm.
  • Life expectancy>6 months
  • Informed consented

Who cannot join

  • Chemotherapy before
  • Bone marrow transplantation before
  • History of malignancy
  • Active infectious disease requiring general antibiotics, anti-fungal or anti-virus therapy
  • Uncontrollable cardio-cerebral vascular, coagulative, autoimmune, serious infectious disease
  • Primary cutaneous, CNS, mediastinal DLBCL
Show all 19Show fewer
  • LVEF≤50%
  • 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
  • Active liver or biliary disease
  • 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

12 sites in 1 country.

12 sites in 1 country

China12 sites

  • West China Hospital

    Chengdu, Sichuan

  • Southwest Hospital

    Chongqing, Chongqing Municipality

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian

  • Guangdong General Hospital

    Guangzhou, Guangdong

  • Shandong Provincal Hospital

    Jinan

  • Jiangsu Province Hospital

    Nanjing, Jiangsu

  • Shanghai Ruijin Hospital

    Shanghai, 200025

  • The first hospital of China medical university

    Shenyang, Liaoning

  • Shanxi Provincial Tumor Hospital

    Taiyuan, Shanxi

  • Institute of Hematology and Blood Diseases Hospital

    Tianjin, Tianjin Municipality

  • Tongji Hospital

    Wuhan, Hubei

  • Henan Cancer Hospital

    Zhengzhou, Henan

Other trials in China

About this study

Official title: A Multi-center, Prospective, Randomized Phase III Study of the Safety and Efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B

The main purpose of this study is to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.

Read the detailed description

The study aims to evaluate the safety and efficacy of R-CEOP-90/R-CEOP-70 Versus R-CHOP-50 in the Treatment of Diffuse Large B-cell lymphoma and Follicular Lymphoma Grade 3B patients.

Being tested
R-CEOP-70, R-CEOP-90, R-CHOP-50
Keywords
diffuse large B-cell lymphoma, follicular lymphoma grade 3B
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-CEOP-70Drug

  • R-CEOP-90Drug

  • R-CHOP-50Drug

Study groups in NCT01852435
Study groupRoleWhat they receive
R-CHOP-50Active comparatorR-CHOP-50 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 50mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Receives: Drug: R-CHOP-50
R-CEOP-70ExperimentalR-CEOP-70 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 70mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Receives: Drug: R-CEOP-70
R-CEOP-90ExperimentalR-CEOP-90 (Rituximab 375 mg/m2 d1+Cyclophosphomide 750mg/m2 d2+Adriamycin 90mg/m2 d2+vincristine 1.4mg/m2 d2+Prednisone 60 mg/m2 d2-6) every 21 days for 6 cycles, followed by Rituximab 375 mg/m2 every 21 days for 2 cycles.
Receives: Drug: R-CEOP-90

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. progression free survival

    Measured: 2 year

Secondary outcomes (3)

  1. overall survival

    Measured: 2 year

  2. Response rate

    21 days as one cycle

    Measured: Every 4 cycles during treatment and then every 3 months for 2 years

  3. Safety as assessed using the CTCAE

    21 days as one cycle

    Measured: Days 1 of each course 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.

  1. First posted13 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionDec 2017 (estimated)
  4. Study completionFeb 2018 (estimated)

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
648 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01852435
Sponsor's protocol ID
NHL-001
Status last verified
Nov 2017
First submitted
8 May 2013
Last updated
14 Nov 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Sun R, Zheng Z, Wang L, Cheng S, Shi Q, Qu B, Fu D, Leboeuf C, Zhao Y, Ye J, Janin A, Zhao WL. A novel prognostic model based on four circulating miRNA in diffuse large B-cell lymphoma: implications for the roles of MDSC and Th17 cells in lymphoma progression. Mol Oncol. 2021 Jan;15(1):246-261. doi: 10.1002/1878-0261.12834. Epub 2020 Nov 9.

    PubMed 33107145

  • Xu PP, Fu D, Li JY, Hu JD, Wang X, Zhou JF, Yu H, Zhao X, Huang YH, Jiang L, Liu F, Su LP, Chen ZW, Zeng QS, Chen JP, Fang MY, Ma J, Liu T, Song YP, Yu K, Li Y, Qiu LG, Chen XQ, Gu J, Yan JS, Hou M, Huang HY, Wang L, Cheng S, Shen Y, Xiong H, Chen SJ, Zhao WL. Anthracycline dose optimisation in patients with diffuse large B-cell lymphoma: a multicentre, phase 3, randomised, controlled trial. Lancet Haematol. 2019 Jun;6(6):e328-e337. doi: 10.1016/S2352-3026(19)30051-1.

    PubMed 31126528

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing R-CEOP-70, R-CEOP-90 and R-CHOP-50 in people with Diffuse Large B-cell Lymphoma and Follicular Lymphoma Grade 3B, run by Ruijin Hospital at 12 sites 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 19 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 12 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 NCT01852435, which also lists 2 linked publications.

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.

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