drugset / Trial / NCT02374424
Phase II Study With Ga101-DHAP as Induction Therapy in Relapsed/Refractory DLBCL Patients
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2014-11-05
- Primary completion
- 2018-02
- Completion
- 2020-06-23
Outcome
Outcome not reported
Stopped (Enrollment): “Interim analysis planned as per protocol didn't provide positive outcome therefore enrollment was not reopened. However, the enrolled patients concluded therapy and continued into the follow-up phase. The study was closed only after LVLP.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Obinutuzumab | Monoclonal antibody | 1000 mg | Intravenous |
| Background | Cisplatin | Other / unclassified | 100 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | 2000 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | 40 mg | — |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |