Lower Dose Decitabine Based Therapy in Patients With Refractory and/or Chemotherapy Resistant Solid Tumors or B Cell Lymphomas (CIK)
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|ClinicalTrials.gov Identifier: NCT01799083|
Recruitment Status : Unknown
Verified January 2016 by Han weidong, Chinese PLA General Hospital.
Recruitment status was: Recruiting
First Posted : February 26, 2013
Last Update Posted : January 28, 2016
|Condition or disease||Intervention/treatment||Phase|
|Solid Tumors B Cell Lymphoma||Drug: Decitabine Biological: cytokine-induced killer cell||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase 1/2 Study of Decitabine Alone and/or in Combination With Chemotherapy and/or Cytokine Induced Killer Cell Transfusion in Patients With Relapsed or Refractory Solid Tumors and B Cell Lymphomas|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||December 2017|
A continuous 5-day treatment of lower dose decitabine within 4-6 weeks is regarded as a treatment cycle, transfusion of auto-CIK cells or chemotherapy regimen may be used for patients.
A continuous 5-day lower-dose decitabine transfusion will be performed for patients during each treatment cycle, and autologous cytokine-induced killer cells may be transfused or chemotherapy may be also added.
Other Name: Dacogen
Biological: cytokine-induced killer cell
Autologous cytokine-induced killer cells may be used for patients before and after decitabine treatment.
Other Name: CIK transfusion
- Response confirmed by non-investigational CT or MRI, or confirmed by biopsy [ Time Frame: within the first 30 days after four-cycle treatment ]
- tumor marker [ Time Frame: at least once within 30 days afther completing four-cycle treatment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01799083
|Biotherapeutic Department of Chinese PLA General Hospital||Recruiting|
|Beijing, Beijing, China, 100853|
|Contact: Wei D Han, Doctor +86-10-66937463 firstname.lastname@example.org|
|Contact: Xue C Lu, Doctor +86-10-66876237 email@example.com|
|Sub-Investigator: Yang Liu, Master|
|Sub-Investigator: Bo Yang, Doctor|
|Sub-Investigator: Yao Wang, Master|
|Sub-Investigator: Yan Zhang, Doctor|
|Principal Investigator: Wei D Han, Doctor|
|Sub-Investigator: Xue C Lu, Doctor|