Trials / Withdrawn
WithdrawnNCT05966233
R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient With Relapsed or Refractory Diffuse Large B Cell Lymphoma
Phase II Randomized Clinical Trial to Evaluate the Efficacy of the Addition of Polatuzumab Vedotin to Standard Chemotherapy R-DHAP (POLA-R-DHAP) as Induction Pre-transplantation Therapy in Patients With Diffuse Large B-Cell Lymphoma Refractory/Relapsed After First Line Treatment.
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Fondazione Italiana Linfomi - ETS · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
Prospective, multicenter, open label, phase II randomized clinical trial in DLBCL patients relapsed or refractory to first line R-chemo, aged 18-70 years and candidate to autologous transplant. Patients will be randomized 1:1 to received 4 cycles of R-DHAP or R-DHAP plus Polatuzumab Vedotin as induction treatment plus autologous transplant.
Detailed description
Prospective, multicenter, open label, phase II randomized clinical trial in DLBCL patients relapsed or refractory to first line R-chemo, aged 18-70 years and candidate to autologous transplant. Patients will be randomized 1:1 to received 4 cycles of R-DHAP or R-DHAP plus Polatuzumab Vedotin as induction treatment. PET-CT scan performed after induction be centrally review for disease response. Responding patients (CR) after induction will be addressed to receive Autologous Stem Cells Transplantation (ASCT) consolidation as per local guidelines. Patients achieving PR can proceed with ASCT or with a 3rd-line treatment, according to the physician judgment. Patients in SD/PD will be diverted to salvage strategies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | R-DHAP | * Rituximab 375 mg/m2 IV on D0 or D1 * Dexamethasone 40 mg/day IV or PO on D1-4 * Ara-C 2 g/m2 IV on D2 (2 doses every 12h) or D2 and D3 * Cisplatin 100 mg/ m2 IV on D1 |
| DRUG | Pola-R-DHAP | * Polatuzumab Vedotin 1.8 mg/kg IV on D1 * Rituximab 375 mg/m2 IV on D0 or D1 * Dexamethasone 40 mg/day IV or PO on D1-4 * Ara-C 2 g/m2 IV on D2 (2 doses every 12h) or D2 and D3 * Cisplatin 100 mg/ m2 IV on D1 |
Timeline
- Start date
- 2024-01-01
- Primary completion
- 2029-01-01
- Completion
- 2029-01-01
- First posted
- 2023-07-28
- Last updated
- 2024-05-21
Locations
37 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT05966233. Inclusion in this directory is not an endorsement.