Trial of R-GemOx Regimen in Previously Untreated Elderly Patients With DLBCL.
|ClinicalTrials.gov Identifier: NCT01670370|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2012
Last Update Posted : April 11, 2018
|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 2018|
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
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|