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Diffuse Large B Cell LymphomaPhase 3NCT02772822

A Study Comparing the Efficiency and Safety of S-CHOP(Cyclophosphamide, Hydroxydaunomycin, Oncovin, and Prednisone) Versus R-CHOP in Untreated CD20(Cluster of Differentiation Antigen 20)-Positive DLBCL Patients

A Phase 3 study testing SCT400 plus CHOP and Rituximab plus CHOP in people with Diffuse Large B Cell Lymphoma, run by Sinocelltech Ltd. at 1 site 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 The sponsor has not verified this record for over two years, so it may be out of date.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 primary objective of the study is to assess the efficiency of SCT400 plus CHOP versus Rituximab plus CHOP in untreated CD20-positive DLBCL Patients. The secondary objective of the study is to evaluate the safety of SCT400 plus CHOP, as well as the presence of human anti-chimeric antibodies (HACA). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Diffuse Large B Cell Lymphoma
What is being tested?
SCT400 plus CHOP and Rituximab plus CHOP
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
330 participants
Where
1 siteChina
Study dates
Jun 2016to Dec 2019
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Untreated CD20-positive DLBCL confirmed by local histopathology.
  • International Prognostic Index (IPI) score of 0 to 2:
  • Score 0 needs to accompanied by bulky disease, which is defined as the presence of a tumor mass with a diameter of more than 7.5 cm.
  • 18 years to 70 years; Male or female patients.
  • More than 6 months life expectancy.
  • At least one measurable lymph node:
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  • For nodal tumor mass, more than 1.5 cm in the long axis and more than 1.0 cm in the short axis; For extranodal tumor mass, more than 1.0 cm in the long axis.
  • Eastern Cooperative Oncology Group(ECOG) performance status of 0 to 2.
  • Adequate cardiac function (LVEF≥50%).
  • Adequate hematological function: absolute neutrophil count(ANC) ≥1.5*109/L and platelet count(PLT) ≥75*109/L.
  • Fertile patients must use effective contraception during the treatment and within 3 months after the treatment.
  • Signed an informed consent form which was approved by the institutional review board of the respective medical center.

Who cannot join

  • Known allergic reactions against human or murine monoclonal antibody, murine products, or foreign proteins.
  • Known allergic reactions against any component of CHOP regimen.
  • Previous treatment for DLBCL, including chemotherapy, immunotherapy, partial radiotherapy for lymphoma, monoclonal antibody therapy or surgical treatment (excluding lymph node biopsies and surgical resection for non-lymphoma lesions).
  • History of cytotoxic drugs treatment or anti-CD20 monoclonal antibody treatment for other disease (e.g., rheumatoid arthritis), or prior use of any monoclonal antibody within 3 months.
  • Primary central nervous system(CNS) lymphoma, secondary CNS involvement, grey zone lymphoma (GZL) between burkitt and DLBCL, primary effusion lymphoma, plasmablastic lymphoma, primary cutaneous DLBCL, anaplastic lymphoma kinase(ALK) positive DLBCL or transformed lymphoma.
  • History of other cancer within the past 5 years except cured basal cell skin cancer, squamous cell carcinoma, cutaneous melanoma or carcinoma in situ of the cervix.
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  • Patients who have significant cardiac disease, including heart disease of grade Ⅲ of Ⅳ according to the New York Heart Association(NYHA) system, or occurrence of myocardial infarction, unstable arrhythmia, unstable angina or severe hypertension in the past 6 months or peripheral nervous system(PNS) or CNS disease.
  • Previously suffered from progressive multifocal leukoencephalopathy.
  • Having continuous treatment of corticosteroid drugs lasting for more than 10 days:
  • Prednisone with the dosage over 30mg/day; Other corticosteroid drugs with equal dosage.
  • Participation in another clinical trial in the past 3 months.
  • Recent major surgery within 4 weeks.
  • Use of hemopoietic cytokine in the past 2 weeks, e.g. granulocyte colony stimulating factor(G-CSF).
  • Vaccination with a attenuated live vaccine within 4 weeks.
  • Abnormal laboratory values:
  • Creatinine more than 1.5 times normal value; Aspartate aminotransferase(AST) or alanine aminotransferase(ALT) more than 2.5 times normal value (5 times if hepatic involvement); total bilirubin(T-BIT) more than 1.5 times normal value(3 times if hepatic involvement); Without anticoagulant therapy, partial thromboplastin time(PTT), activated partial thromboplastin time(APTT) or international normalized ratio(INR) more than 1.5 times normal value.
  • Active Infectious disease or significant infections requiring intravenous antibiotic therapy or hospitalization in the past 4 weeks (exception of tumor induced fever).
  • Suspected active or latent tuberculosis.
  • Seropositive for human immunodeficiency virus (HIV) or hepatitis C antibodies. Hepatitis B virus(HBV) positive patient (including positive hepatitis B surface antigen or positive hepatitis B virus core antibody) may participate if his serum HBV DNA level is sufficient low.
  • Other disease or symptom by the investigator's discretion.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100076

Other trials in China

About this study

Official title: A Phase Ⅲ, Multi-center, Randomized, Controlled Study to Compare the Efficiency and Safety of SCT400(Recombinant Chimeric Anti-CD20 Monoclonal Antibody, Experimental Drug) Plus CHOP Versus Rituximab Plus CHOP in Untreated CD20-positive DLBCL Patients

The primary objective of the study is to assess the efficiency of SCT400 plus CHOP versus Rituximab plus CHOP in untreated CD20-positive DLBCL Patients.

The secondary objective of the study is to evaluate the safety of SCT400 plus CHOP, as well as the presence of human anti-chimeric antibodies (HACA).

Being tested
SCT400 plus CHOP, Rituximab plus CHOP
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.

  • SCT400 plus CHOPDrug

  • Rituximab plus CHOPDrug

Study groups in NCT02772822
Study groupRoleWhat they receive
ExperimentalExperimentalSCT400 plus CHOP, six cycles SCT400: 375 mg/m2, IV, day 1 of each cycle Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle Doxorubicin: 50 mg/m2, IV, day 2 of each cycle Vincristine: 1.4 mg/m2, up to a maximal dose of 2 mg, IV, day 2 of each cycle Prednisone: 100 mg, po, day 2 to day 6 of each cycle
Receives: Drug: SCT400 plus CHOP
Active ComparatorActive comparatorRituximab plus CHOP, six cycles Rituximab: 375 mg/m2, IV, day 1 of each cycle Cyclophosphamide: 750 mg/m2, IV, day 2 of each cycle Doxorubicin: 50 mg/m2, IV, day 2 of each cycle Vincristine: 1.4 mg/m2, up to a maximal dose of 2 mg, IV, day 2 of each cycle Prednisone: 100 mg, po, day 2 to day 6 of each cycle
Receives: Drug: Rituximab plus CHOP

What is being measured

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

  1. Overall response rate(ORR) after completion of treatment

    Measured: 18 weeks

Secondary outcomes (7)

  1. Complete remission(CR) plus complete remission/unconfirmed(CRu) after completion of treatment

    Measured: 18 weeks

  2. Progression-free survival(PFS)

    Measured: 1 year

  3. Event-free survival(EFS) at 1 year and directly after an event, whichever comes first. The events are defined as progressive disease, relapse, death from any cause, or new anticancer treatment

    Measured: 1 year

  4. Duration of remission(DOR) measured from prior achievement of complete remission or partial remission to occurrence of an event or at 1 year, whichever comes first. The events are defined as progressive disease, relapse of death from any cause

    Measured: 1 year

  5. Overall survival(OS)

    Measured: 1 year

  6. Comparison of adverse events(AEs) between the two study arms

    Measured: 1 year

  7. Number of participants with seropositive for human anti-chimeric antibody(HACA) between the two study arms

    Measured: 1 year

Timeline

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

  1. First posted16 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJun 2019 (estimated)
  4. Study completionDec 2019 (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
Single blind
Who is masked
Participant
Enrolment
330 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02772822
Sponsor's protocol ID
SCT400NHL3
Status last verified
May 2016
First submitted
6 May 2016
Last updated
16 May 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SCT400 plus CHOP and Rituximab plus CHOP in people with Diffuse Large B Cell Lymphoma, run by Sinocelltech Ltd. 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 12 inclusion and 20 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 16 May 2016. 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?

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?

Overall response rate(ORR) after completion of treatment (time frame: 18 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 NCT02772822.

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 16 May 2016.

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