NCT02374424

Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients

Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Lymphoma (DLBCL) Patients Before High-Dose Chemotherapy BEAM With Autologous Stem Cell Transplantation (ASCT)

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Fondazione Italiana Linfomi - ETS · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Aim of this trial is to assess the efficacy of new anti-CD20 antibody (GA101) in association with DHAP as induction therapy before high dose chemotherapy BEAM with ASCT in patients with relapsed/refractory DLBCL.

Detailed description

This is a prospective, multicenter, single arm, phase II trial 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 assess whether the addition of GA101 to DHAP is more promising than standard R-DHAP, as induction therapy before high dose chemotherapy BEAM with ASCT with respect to response. The study is designed primarily to evaluate the efficacy of GA101-DHAP in patients with DLBCL who have relapsed or are refractory to one chemotherapy regimen and secondarily to assess safety and capability to mobilize peripheral stem cells The study is designed with two stages and with stopping rules after the first stage. In particular, at the end of the first stage, the study will be stopped if the efficacy is too low or if the toxicity, measured during the drug administration period, is too high with respect to pre-defined thresholds. .

Conditions

• Diffuse, Large B-Cell, Lymphoma

Interventions

Type	Name	Description
DRUG	GA101_DHAP	Aim of the study is to assess whether the addition of GA101 to DHAP is more promising than standard R-DHAP, as induction therapy before high dose chemotherapy BEAM with ASCT with respect to response. Scheme of treatment: * GA101 1000 mg iv day 1, 8, 15 on first cycle (starting from cycle 2, GA101 1000 mg day 1) * Cisplatin 100 mg/sqm iv day 1 of every cycles in 24-hours infusion * Cytarabine 2000 mg/sqm in 3-hours infusion every 12 hours iv day 2 of every cycles * Dexamethasone 40 mg day 1-4 of every cycles * Pegfilgrastim 6 mg sc single dose 24 hours after the end of chemotherapy or G-CSF from day 4 till stem cell harvest during mobilization's course (II o III cycle GA101-DHAP) * GA101 1000 mg iv 24 hours before apheresis as purging in vivo during second courses of therapy

Timeline

• Start date: 2014-11-05
• Primary completion: 2018-02-01
• Completion: 2020-06-23
• First posted: 2015-02-27
• Last updated: 2022-06-06

Locations

10 sites across 1 country: Italy