LymphomasCIKNCT01828008
Treatment of CD20 Antibody Plus CIK for Patients With Refractory Lymphomas
An observational study of Lymphomas, run by Han weidong.
Trial summary
To study the safety and efficacy of CD20 antibody usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lymphomas
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Apr 2013to May 2015
- How long will I take part?
- 5 Years
- Phase
- Observational
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: the patients with CD20-positive Lymphomas
Who may be able to join
- diagnosed as B-cell lymphoma with CD20 positiveness, and need to therapy
Who cannot join
- to refuse the therapy and need not tolerate the therapy
About this study
To study the safety and efficacy of CD20 antibody usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas.
Read the detailed description
Autologous CIK transfusion within 3 days post CD20 antibody treatment.
- Conditions
- Lymphomas
- Keywords
- Mabthera, cytokine induced killer cell
- Medical subject headings
- Lymphoma
What is being measured
The primary outcome is the main question the study is designed to answer.
disease free survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphomasStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Han weidong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Han weidong, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01828008
- Sponsor's protocol ID
- BT-004
- Acronym
- CIK
- Status last verified
- Jan 2013
- First submitted
- 6 Apr 2013
- Last updated
- 10 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of CD20 Antibody Plus CIK for Patients With Refractory Lymphomas
- ClinicalTrials.gov ID
- NCT01828008
- Acronym / sponsor ID
- CIK / BT-004
- Conditions
- Lymphomas
- Keywords
- Mabthera, cytokine induced killer cell
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Han weidongUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 10 Apr 2013 (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.
To study the safety and efficacy of CD20 antibody usage followed by CIK transfusion in refractory and/or chemoresistant lymphomas.
Detailed description
Autologous CIK transfusion within 3 days post CD20 antibody treatment.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- the patients with CD20-positive Lymphomas
Key inclusion criteria (1 listed)
- diagnosed as B-cell lymphoma with CD20 positiveness, and need to therapy
Key exclusion criteria (1 listed)
- to refuse the therapy and need not tolerate the therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
disease free survival
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphomas, run by Han weidong.
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 1 inclusion and 1 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 10 Apr 2013. 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.
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?
disease free survival (time frame: 5 years). 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 10 Apr 2013.