Treatment of CD20 Antibody Plus CIK for Patients With Refractory Lymphomas (CIK)
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| ClinicalTrials.gov Identifier: NCT01828008 |
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Recruitment Status : Unknown
Verified January 2013 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Not yet recruiting
First Posted : April 10, 2013
Last Update Posted : April 10, 2013
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Sponsor:
Han weidong
Information provided by (Responsible Party):
Han weidong, Chinese PLA General Hospital
| Tracking Information | |||
|---|---|---|---|
| First Submitted Date | April 6, 2013 | ||
| First Posted Date | April 10, 2013 | ||
| Last Update Posted Date | April 10, 2013 | ||
| Study Start Date | April 2013 | ||
| Estimated Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures |
disease free survival [ Time Frame: 5 years ] | ||
| Original Primary Outcome Measures | Same as current | ||
| Change History | No Changes Posted | ||
| Current Secondary Outcome Measures | Not Provided | ||
| Original Secondary Outcome Measures | Not Provided | ||
| Current Other Pre-specified Outcome Measures | Not Provided | ||
| Original Other Pre-specified Outcome Measures | Not Provided | ||
| Descriptive Information | |||
| Brief Title | Treatment of CD20 Antibody Plus CIK for Patients With Refractory Lymphomas | ||
| Official Title | Not Provided | ||
| Brief Summary | 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 Type | Observational [Patient Registry] | ||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | 5 Years | ||
| Biospecimen | Not Provided | ||
| Sampling Method | Probability Sample | ||
| Study Population | the patients with CD20-positive Lymphomas | ||
| Condition | Lymphomas | ||
| Intervention | Not Provided | ||
| Study Groups/Cohorts | Not Provided | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Unknown status | ||
| Estimated Enrollment |
20 | ||
| Original Estimated Enrollment | Same as current | ||
| Estimated Study Completion Date | May 2015 | ||
| Estimated Primary Completion Date | May 2015 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria | Inclusion Criteria: - diagnosed as B-cell lymphoma with CD20 positiveness, and need to therapy Exclusion Criteria: - to refuse the therapy and need not tolerate the therapy |
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| Sex/Gender |
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| Ages | 18 Years to 90 Years (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||
| Listed Location Countries | Not Provided | ||
| Removed Location Countries | |||
| Administrative Information | |||
| NCT Number | NCT01828008 | ||
| Other Study ID Numbers | BT-004 | ||
| Has Data Monitoring Committee | Yes | ||
| U.S. FDA-regulated Product | Not Provided | ||
| IPD Sharing Statement | Not Provided | ||
| Responsible Party | Han weidong, Chinese PLA General Hospital | ||
| Study Sponsor | Han weidong | ||
| Collaborators | Not Provided | ||
| Investigators | Not Provided | ||
| PRS Account | Chinese PLA General Hospital | ||
| Verification Date | January 2013 | ||