NCT05966233 (FIL_POLARDHAP) is a Phase 2 clinical trial of R-DHAP in Diffuse Large B Cell Lymphoma Refractory, sponsored by Fondazione Italiana Linfomi - ETS.

Who is sponsoring NCT05966233?

NCT05966233 is sponsored by Fondazione Italiana Linfomi - ETS.

What drugs are being tested in NCT05966233?

Interventions in NCT05966233: R-DHAP, Pola-R-DHAP.

What condition does NCT05966233 study?

NCT05966233 studies Diffuse Large B Cell Lymphoma Refractory, Diffuse Large B-cell Lymphoma Recurrent.

Is NCT05966233 still recruiting?

NCT05966233 is currently withdrawn. Last updated 20 May 2024.

Last reviewed 2024-05-20 · How we verify

NCT05966233: FIL_POLARDHAP

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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.

Withdrawn Phase 2 Last updated 20 May 2024

What this trial tests

Phase 2 trial testing R-DHAP in Diffuse Large B Cell Lymphoma Refractory. Withdrawn.

Timeline

1 January 2024

Primary endpoint
1 January 2029

1 January 2029

Quick facts

Lead sponsor	Fondazione Italiana Linfomi - ETS
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Start date	1 January 2024
Primary completion	1 January 2029
Estimated completion	1 January 2029
Sites	37 locations across Italy

Drugs / interventions tested

R-DHAP — full drug profile →
Pola-R-DHAP — full drug profile →

Conditions studied

Diffuse Large B Cell Lymphoma Refractory — all drugs for Diffuse Large B Cell Lymphoma Refractory →
Diffuse Large B-cell Lymphoma Recurrent — all drugs for Diffuse Large B-cell Lymphoma Recurrent →

Sponsor

Fondazione Italiana Linfomi - ETS — full company profile →

Who can join

Adults 18 to 70, any sex, with Diffuse Large B Cell Lymphoma Refractory or Diffuse Large B-cell Lymphoma Recurrent. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Progression free survival (PFS)
Time frame: From treatment start up to 30 months (6 months treatment period and 24 months of follow-up)
Time between the randomization to first documentation of recurrence, progression or death from any cause

Sponsor's own 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 plus autologous transplant.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of R-DHAP

Trials testing the same drug.

NCT01805557 — Phase II Randomized Study With R-DHAP +/- Bortezomib as Induction Therapy in Relapsed/Refractory Diffuse Large B-cell Ly · Phase 2, PHASE3 · completed

Other recruiting trials for Diffuse Large B Cell Lymphoma Refractory

Currently open trials in the same condition.

NCT06789159 — A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL) · Phase 1 · recruiting

Other Fondazione Italiana Linfomi - ETS trials

Trials by the same sponsor.

NCT07453095 — Study With Glofitamab in Patients With MCL and Inadequate Response or Relapse Following CAR T-cell Therapy · Phase 2 · not yet recruiting
NCT07256158 — PET Guided Dose Reduction for InvOlved Site Radiotherapy In Early sTage Unfavourable Hodgkin Lymphoma · Phase 3 · not yet recruiting
NCT07207785 — PirtobrUtinib as Frontline Therapy for Elderly Unfit/Frail Patient With MAntle Cell Lymphoma · Phase 2 · not yet recruiting
NCT06781359 — Study on Plasmablastic Lymphoma Patients · recruiting
NCT06492837 — Study With Mosunetuzumab and Zanubrutinib in R/R Follicular Lymphoma Patients · Phase 2 · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05966233 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fondazione Italiana Linfomi - ETS
Last refreshed: 20 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05966233.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing