B-cell Non Hodgkin's LymphomaPhase 1NCT02206308
Safety, Pharmacokinetics and Pharmacodynamics of Recombinant Chimeric Anti-CD20 Monoclonal Antibody in Patients With B-cell Non-Hodgkin's Lymphoma.
A Phase 1 study testing Chimeric anti-CD20 monoclonal antibody in people with B-cell Non Hodgkin's Lymphoma, run by Sinocelltech Ltd..
Trial summary
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- B-cell Non Hodgkin's Lymphoma
- What is being tested?
- Chimeric anti-CD20 monoclonal antibody
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- May 2012to Jul 2013
- Phase
- Phase 1
- 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
- aged from 18 to 75 years
- having histologically confirmed NHL expressing CD20 antigen
- having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and expected survival of at least ≥ 3 months
- signed an informed consent form which was approved by the institutional review board of the respective medical center
Who cannot join
- single measurable lesion ≥7 cm in diameter
- with serious hematologic dysfunction (white blood cell count of <3.0×103/μL; absolute neutrophil count of <1.5×103/ μL; platelet count of < 75×103/μL; hemoglobin level of < 8.0 g/dL; serum immunoglobulin G(IgG) level of <600 mg/dL);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×ULN )
- having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
- had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
- had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry
- with other malignancies ; or central nervous system (CNS) lymphoma, AIDS- related lymphoma; or active opportunistic infection, a serious nonmalignant disease
Show all 10Show fewer
- having hepatitis B virus surface antigen and /or antibodies to hepatitis C virus or human immunodeficiency virus
- with pleural effusions or ascites secondary to lymphoma; or high risk of tumor lysis syndrome; or recent major surgery (within 28 days )
- with a history of allergic reaction or protein product allergy including murine proteins
- pregnant or lactating or not accepted birth control methods including male patients
About this study
Official title: A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
- Conditions
- B-cell Non Hodgkin's Lymphoma
- Being tested
- Chimeric anti-CD20 monoclonal antibody
- Keywords
- Chimeric anti-CD20 monoclonal antibody(SCT400), escalating doses, safety, pharmacokinetics and pharmacodynamics
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chimeric anti-CD20 monoclonal antibodyBiological
Also called SCT400
| Study group | Role | What they receive |
|---|---|---|
| single arm | Experimental | Three escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses; Receives: Biological: Chimeric anti-CD20 monoclonal antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with infusion-related reaction and with drug-related adverse events.
Measured: up to 27 weeks
Secondary outcomes (1)
Area Under the plasma concentration versus time curve (AUC) of SCT400
Measured: prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2014 (estimated)
- Study startMay 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell Non Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Sinocelltech Ltd.The 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinocelltech Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuan kai Shi, PhD, Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02206308
- Sponsor's protocol ID
- SCT400NHLI
- Status last verified
- Dec 2013
- First submitted
- 30 Jul 2014
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose Escalation Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SCT400, a Recombinant Chimeric Anti-CD20 Monoclonal Antibody，in Patients With CD20+ B-cell Non Hodgkin's Lymphoma.
- ClinicalTrials.gov ID
- NCT02206308
- Acronym / sponsor ID
- SCT400NHLI
- Conditions
- B-cell Non Hodgkin's Lymphoma
- Keywords
- Chimeric anti-CD20 monoclonal antibody(SCT400), escalating doses, safety, pharmacokinetics and pharmacodynamics
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Sinocelltech Ltd.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 1 Aug 2014 (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.
The purpose of this study is to determine whether SCT400 is safe and effective in the treatment of B-cell Non Hodgkin's lymphoma
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm | Experimental | Biological: Chimeric anti-CD20 monoclonal antibodyThree escalating single-dose groups of chimeric anti-CD20 monoclonal antibody(SCT400) : 250 mg/m2 , 375 mg/m2，500 mg/m2, once a week for 4 doses; |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged from 18 to 75 years
- having histologically confirmed NHL expressing CD20 antigen
- having relapsed non-Hodgkin's lymphoma(NHL) after at least one prior course of standard therapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 according to WHO scale, and expected survival of at least ≥ 3 months
- signed an informed consent form which was approved by the institutional review board of the respective medical center
Key exclusion criteria (10 listed)
- single measurable lesion ≥7 cm in diameter
- with serious hematologic dysfunction (white blood cell count of <3.0×103/μL; absolute neutrophil count of <1.5×103/ μL; platelet count of < 75×103/μL; hemoglobin level of < 8.0 g/dL; serum immunoglobulin G(IgG) level of <600 mg/dL);, hepatic dysfunction (total bilirubin level of > 1.5×upper limit of normal（ULN）; aspartate amino transferase (AST) and alanine amino transferase (ALT) levels of >2.5 × ULN (≥5 × ULN for patients with liver metastases)); and renal dysfunction (serum creatinine level of > 1.5×ULN )
- having to be at least 4 weeks beyond prior anticancer therapy including corticosteroid, or participating in other clinical trial or have not recovered from significant toxicities of prior therapy
- had received rituximab or other anti-CD20(+) monoclonal antibody treatment within 1 year before enrollment
- had received hematopoietic cytokines, e.g CSF、EPO within 1 week prior to study entry
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 |
|---|---|---|
| Chimeric anti-CD20 monoclonal antibodyAlso: SCT400 | Biological | single arm |
Primary outcome
Number of participants with infusion-related reaction and with drug-related adverse events.
Time frame: up to 27 weeks
1 secondary outcome
Area Under the plasma concentration versus time curve (AUC) of SCT400
Time frame: prior to the initial dose on day 1 and 0,2,4,8,24,48,72,96,120 hours post-dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2014.
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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.
Yuan kai Shi, PhD principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences; Beijing， China
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Chimeric anti-CD20 monoclonal antibody in people with B-cell Non Hodgkin's Lymphoma, run by Sinocelltech Ltd..
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 5 inclusion and 10 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 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of participants with infusion-related reaction and with drug-related adverse events. (time frame: up to 27 weeks). 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 Aug 2014.