Decitabine Plus R-CHOP in Diffuse Large B-cell Lymphoma (DR-CHOP)
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|ClinicalTrials.gov Identifier: NCT02951728|
Recruitment Status : Active, not recruiting
First Posted : November 1, 2016
Last Update Posted : March 11, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B Cell Lymphoma||Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: Decitabine||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase I/II Trial of Decitabine + R-CHOP in Diffuse Large B-Cell Lymphoma|
|Study Start Date :||October 2016|
|Actual Primary Completion Date :||May 2019|
|Estimated Study Completion Date :||October 2020|
Experimental: Decitabine plus R-CHOP
Rituximab 375 mg/m2 IV d6; Cyclophosphamide 750mg/m2 IV d7; Doxorubicin 50mg/m2 IV d7; Vincristine 1.4 mg/m2 IV d7; Prednisone 60 mg/m2 PO d7-11;
Decitabine will be administered intravenously at dose levels as follow in Phase 1:
Dose level 1: Decitabine 10 mg/m2 days 1-5; Dose level 2: Decitabine 15 mg/m2 days 1-5; Dose level 3: Decitabine 20 mg/m2 days 1-5 and determine the maximum tolerated dose.
In phase 2, Decitabine will be administered intravenously at MTD.
- maximum tolerated dose [ Time Frame: day1 to 21 ]The primary endpoint for the phase I portion of the study is to determine the maximum tolerated dose of Decitabine when given in combination with a standard dose (q21 day) regimen of R-CHOP in patients with DLBCL.
- complete response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ]The primary endpoint for the phase II portion of the study will be complete response rate.
- Overall response rate [ Time Frame: 21 days after 6 cycles of treatment (each cycle is 21 days) ]
- Event-free survival [ Time Frame: 2 years ]
- Overall survival [ Time Frame: 2 years ]
- Progression-free survival [ Time Frame: 2 years ]
- Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v4.0 [ Time Frame: Up to 30 days after completion of study 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): NCT02951728
|Shanghai Ruijin Hospital|
|Shanghai, China, 20025|
|Principal Investigator:||Weili Zhao, MD，PhD||Shanghai Jiao Tong University School of Medicine|