Phase II Randomized Study With R-DHAP +/- Bortezomib as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Eligible to Transplantation. BR-DHAP Versus R-DHAP. (FIL_VERAL12)
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|ClinicalTrials.gov Identifier: NCT01805557|
Recruitment Status : Active, not recruiting
First Posted : March 6, 2013
Last Update Posted : July 7, 2020
|Condition or disease||Intervention/treatment||Phase|
|Diffuse Large B-cell Lymphoma Refractory Diffuse Large B-cell Lymphoma Recurrent||Drug: R-DHAP Drug: BR-DHAP||Phase 2 Phase 3|
This is a prospective, multicenter, two-arm randomized phase II screening trial34 in young patients (18-65 years) affected by relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL) at diagnosis, eligible to high-dose therapy.
Aim of the study is to to assess whether the addition of Bortezomib to R-DHAP is more promising than standard R-DHAP, as induction therapy before high dose chemotherapy with ASCT with respect to response and safety. Patients will be randomized at first relapse between: a) the standard salvage therapy Rituximab in association to DHAP every 28 days (R-DHAP) for 4 cycles and b) Bortezomib in association to the same regimen (BR-DHAP). In both arms the induction therapy is followed by autologous stem cell transplantation or, if indicated, by allogeneic stem cell transplant.
A patient is considered evaluable if it is possible to assess response by PET after 4 cycle or, if a patient withdraws from the study for PD, before completion of study treatment.
After providing written informed consent, patients will be evaluated for eligibility during a 21-day screening period. If they continue to meet eligibility criteria, they will be randomized to receive the first dose of BR-DHAP or R-DHAP .
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||108 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Randomized Study With R-DHAP +/- Bortezomib as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Eligible to Transplantation. BR-DHAP Versus R-DHAP.|
|Actual Study Start Date :||February 4, 2013|
|Actual Primary Completion Date :||March 12, 2019|
|Estimated Study Completion Date :||November 21, 2020|
Active Comparator: R-DHAP
R-DHAP x 2, restaging, mobilization and harvest of peripheral stem cell + R-DHAP x 2, restaging with PET evaluation
Bortezomib + R-DHAP x 2, restaging, mobilization and harvest of peripheral stem cell + Bortezomib + R-DHAP x 2, restaging with PET evaluation
- Complete Response (CR) Rate [ Time Frame: At the end of the induction phase (6 months) ]Proportion of CR according to the Cheson 2007 response criteria, evaluated by PET scan
- Overall Response Rate (ORR) [ Time Frame: At the end of the induction phase (6 months) ]ORR at the end of the induction treatment is defined as Complete Response (CR) or Partial Response according to the Cheson 2007 response criteria, evaluated by PET scan
- Overall Survival (OS) [ Time Frame: 36 months ]OS will be defined as the time between the date of randomization and the date of death from any cause
- Number of Patients With Treatment-Related Adverse Events (AEs)/Serious Adverse Events (SAEs) as a Measure of Safety [ Time Frame: 12 months ]Incidence of grade 3 or higher Toxicity measured by CTCAE v.4 during therapy
- Mobilizing potential [ Time Frame: 6 months ]Amount of CD34+ stem cell collected/Kg
- Number of Patients completing ASCT [ Time Frame: 12 months ]Proportion of randomized patients successfully completing ASCT
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): NCT01805557
|Study Director:||Umberto Vitolo, MD||SC Ematologia 2-AO Città della Salute e della Sienza-Molinette|