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Diffuse Large B-Cell LymphomaPhase 3NCT04361279

A Study Comparing SIBP-02 and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL

A Phase 3 study testing SIBP-02 and Rituximab in people with Diffuse Large B-Cell Lymphoma, run by Shanghai Institute Of Biological Products at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a randomised, double-blind, positive drug parallel controlled equivalence clinical trial initiated at about 30 sites in China. In the trial, it is planned to enroll 414 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diffuse Large B-Cell Lymphoma
What is being tested?
SIBP-02 and Rituximab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
421 participants
Where
1 siteChina
Study dates
25 Jul 2019to 20 May 2022
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 18-75 years old, male or female;
  • Patients diagnosed as CD20-positive diffuse large B-cell lymphoma after histopathological or cytological examination and untreated;
  • ECOG score ≤ 2 when enrolled;
  • Echocardiography measured LVEF ≥ 50%;
  • The laboratory indicators during the screening period shall meet the following criteria:
  • White blood cell count (WBC) ≥ 4.0 × 109/L or the lower limit of normal of the local laboratory; patients with bone marrow invasion, WBC ≥ 3.0 × 109/L; Absolute neutrophil count (ANC) ≥ 2.0 × 109/L or the lower limit of normal of the local laboratory; in the patients with bone marrow invasion, ANC ≥ 1.5 × 109/L; Hemoglobin (HB) ≥ 90 g/L; in the patients with bone marrow invasion, HB ≥ 80 g/L; Platelets (PLT) ≥ 100 × 109/L; in the patients with bone marrow invasion, PLT ≥ 75 × 109/L; Total bilirubin ≤ 1.5 times upper limit of normal (ULN); Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN; Alkaline phosphatase ≤ 1.5 × ULN in the patients without bone marrow invasion; Serum creatinine level ≤ 1.5 × ULN;
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  • Patients having at least one two-dimensional measurable lesion as the basis for evaluation: for intra-nodal lesions, ≥1.5 cm in the long diameter and ≥1.0 cm in the short diameter; for extra-nodal lesions, ≥1.0 cm in the long diameter;
  • Patients with lymphoma International Prognostic Index (IPI) score of 0-2, with stage I to IV;
  • Female at the childbearing age who show negative in the pregnancy test, and agree to take effective contraceptive measures during the study period and within 12 months after the last dose; male patients who agree to take effective contraceptive measures during the study period and within 3 months after the last dose;
  • Patients with the expected survival period of greater than 6 months;
  • Patients voluntary to sign the Informed Consent Form.

Who cannot join

  • Patients with primary central nervous system lymphoma and secondary central nervous system invasion, gray zone lymphoma between Burkitt and DLBCL, gray zone lymphoma between DLBCL and HL, primary mediastinal DLBCL, primary exudative lymphoma, plasmablastic lymphoma, primary skin DLBCL, ALK-positive DLBCL or transformed lymphoma;
  • Patients with double hit (BCL-2 and c-MYC gene rearrangement) or triple hit (BCL-2, BCL-6 and c-MYC gene rearrangement) diffuse large B-cell lymphoma diagnosed by the FISH test method; or patients with the pathological immunohistochemical test results as follows: BCL-2 ≥70% positive and c-MYC≥40% positive and tumor cells judged to be the source of germinal center according to Han's evaluation criteria but without exact FISH test result;
  • Patients with history of malignant tumors other than cutaneous squamous cell carcinoma, cutaneous basal cell carcinoma and cervical carcinoma in situ within 5 years prior to enrollment;
  • Patients with major surgery (excluding diagnostic surgery) within 2 months prior to enrollment;
  • Patients treated for non-Hodgkin's lymphoma:
  • Chemotherapy and immunotherapy; Radiotherapy or local radiotherapy for DLBCL; Monoclonal antibody therapy (including Rituxan® and biosimilars of Rituxan®) Surgery (except biopsy);
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  • Patients previously receiving cytotoxic drugs or anti-CD20 antibodies to treat other diseases (e.g. rheumatoid arthritis);
  • Patients receiving any monoclonal antibody within 3 months prior to enrollment;
  • Patients who participated in other clinical trials and used other trial-related drugs within 3 months prior to enrollment;
  • Those vaccinated within 1 month prior to enrollment;
  • Those receiving hematopoietic cytokines, e.g. granulocyte colony-stimulating factor (G-CSF) within 2 weeks prior to enrollment;
  • Those with the maximum dose of >100mg Prednisone Acetate Tablets or equivalent cortisols for more than 5 days for the purpose of controlling lymphoma, or with the daily dose of >30mg Prednisone Acetate Tablets or equivalent cortisols for more than 10 days for the other purposes. For the patients with daily dose of ≤30mg Prednisone Acetate Tablets or equivalent cortisols, there shall be written record on stable use of pre-randomization dose for at least 4 weeks;
  • Patients with peripheral nervous system or central nervous system disorder;
  • Patients with suspected active or latent tuberculosis;
  • Patients with known uncontrolled active bacterial, viral, fungal, mycobacterial, parasitic or other infections (excluding nail bed fungal infection) or with any significant systemic infection event that requires intravenous antibiotic treatment or hospitalization (except for neoplastic fever) within 4 weeks prior to enrollment;
  • HIV antibody positive;
  • HCV antibody positive;
  • HBV infection: (1) HBsAg positive, or (2) HBsAg negative, HBcAb positive and HBV DNA > 1 × 103
  • Patients with complicated other diseases that might restrict the patients from participation in the clinical trial in the opinion of the investigator, including but not limited to:
  • Cardiovascular disease: congestive heart failure (NYHA Class III-IV), unstable angina, poorly controlled arrhythmias, poorly controlled hypertension or hypotension or myocardial infarction in the past 6 months; Severe mental illness; Gastric ulcer, intestinal infarction or gastrointestinal perforation (except for ones caused by primary disease); Pulmonary diseases (asthma, interstitial lung disease or severe obstructive pulmonary disease); Poorly controlled diabetes.
  • Patients with contraindication to any drug in the CHOP chemotherapy regime;
  • Patients with allergy constitution or known to be allergic to the active ingredient, excipient or rodent product or xenogeneic protein of any drug contained in this clinical trial (including the CHOP regime);
  • Patients unsuitable for enrollment due to alcohol or drug abuse in the opinion of the investigator;
  • Female in the pregnancy or breast-feeding period;
  • Those unsuitable to participate in the clinical trial in the opinion of the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital of College of Medicine, Zhejiang University

    Hangzhou

Other trials in China

About this study

Official title: A Phase III, Multicenter, Randomized, Double-blind Study Comparing the Efficacy and Safety of SIBP-02 (Rituximab Biosimilar) and Rituximab Combination With CHOP in Previously Untreated Subjects With CD20+ DLBCL

This is a randomised, double-blind, positive drug parallel controlled equivalence clinical trial initiated at about 30 sites in China.

In the trial, it is planned to enroll 414 subjects, randomized to two treatment groups in a ratio of 1:1 to receive the test drug and the positive control.

Being tested
SIBP-02, Rituximab
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.

  • SIBP-02Drug

    Injection，100mg/10ml

  • RituximabDrug

    Injection，100mg/10ml

Study groups in NCT04361279
Study groupRoleWhat they receive
SIBP-02ExperimentalBiological: SIBP-02, 375 mg/m2, intravenous infusion, administered on day1. Drug: Cyclophosphamide, 750 mg/m2, intravenous infusion, administered on day2. Drug: Doxorubicin Hydrochloride, 50 mg/m2, intravenous infusion, administered on day2. Drug: Vincristine Sulfate, 1.4 mg/m2, intravenous infusion, administered on day2. Drug: Prednisone Acetate Tablets, 100 mg, orally administered on day2-6, one time per day. Treatment cycle: 6 cycles, each cycle is 3 weeks.
Receives: Drug: SIBP-02
RituximabActive comparatorBiological: Rituximab, 375 mg/m2, intravenous infusion, administered on day1. Drug: Cyclophosphamide, 750 mg/m2, intravenous infusion, administered on day2. Drug: Doxorubicin Hydrochloride, 50 mg/m2, intravenous infusion, administered on day2. Drug: Vincristine Sulfate, 1.4 mg/m2, intravenous infusion, administered on day2. Drug: Prednisone Acetate Tablets, 100 mg, orally administered on day2-6, one time per day. Treatment cycle: 6 cycles, each cycle is 3 weeks.
Receives: Drug: Rituximab

What is being measured

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

  1. Overall Response Rate (ORR)

    defined as the proportion of patients with Complete Response (CR) and Partial Response (PR) in accordance with the evaluation criteria of the International Working Group (IWG) Lymphoma Efficacy Evaluation System (2007)

    Measured: After 6 cycles of treatment, each cycle is 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2020
  2. Study start25 Jul 2019
  3. Primary completion20 May 2022
  4. Study completion20 May 2022

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04361279
Sponsor's protocol ID
SIBP-02-03
Status last verified
Dec 2023
First submitted
22 Apr 2020
Last updated
27 Dec 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SIBP-02 and Rituximab in people with Diffuse Large B-Cell Lymphoma, run by Shanghai Institute Of Biological Products 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 11 inclusion and 25 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: finished, as of the sponsor's last update on 27 Dec 2023. 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 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Response Rate (ORR) (time frame: After 6 cycles of treatment, each cycle is 3 weeks). 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 NCT04361279.

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 27 Dec 2023.

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