Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.
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|ClinicalTrials.gov Identifier: NCT01670370|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2012
Last Update Posted : February 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma||Drug: R-GemOx||Phase 2|
Previous studies showed that the combination of rituximab, gemcitabine and oxaliplatin (R-GemOx) achieved high efficacy with a low toxicity profile in relapsed and refractory DLBCL. This regimen might be considered a putative treatment option for elderly patients. To our knowledge, the efficacy and safety of R-GemOx when given as first-line therapy in elderly patients with DLBCL remains unknown. The investigators therefore developed a two-weekly regimen of rituximab combined with GemOx regimen as first line treatment in elderly DLBCL and investigate its efficacy and safety.
Primary Outcome Measures:
- overall response rate
Secondary Outcome Measures:
- progression free survival
- overall survival
- safety and toxicity
Enrollment: 60 Study Start Date: August 2012 Primary Completion Date: Dec 2015
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Single-arm, Open-label, Phase 2 Study to Evaluate Efficacy and Safety of R-GemOx Regimen as First-line Treatment in Elderly Patients With Diffuse Large B-cell Lymphoma (DLBCL).|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2019|
Experimental: Rituximab+Gemcitabine+oxaliplatin (R-GemOx)
Rituximab: 375 mg/m2 IV day1, Gemcitabine 1g/m2 IV day 2, oxaliplatin 100mg/m2 IV day2(every 14 days)
Rituximab Gemcitabine Oxaliplatin
- overall response rate [ Time Frame: at the end of 3 cycles and 6 cycles of R-GemOx regimen(each cycle is 14 days) ]overall response rate after 3 cycles and at the end of R-GemOx regimen.
- progression free survival [ Time Frame: Two-year ]from date of inclusion to date of progression, relapse from response, or death from any cause or last follow-up.
- overall survival [ Time Frame: Two-year ]from the date of inclusion to date of death, irrespective of cause or last follow-up.
- The incidence and severity of adverse events [ Time Frame: Up to 30 days following the last dose of study drug ]All the treatment related adverse events was evaluated according to common terminology criteria adverse events(CTCAE) version 4.0
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): NCT01670370
|Principal Investigator:||WEI XU, M.D., Ph.D.||The First Affiliated Hospital with Nanjing Medical University|