MedTrace Logo

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

NCT05966233 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2024-05-21

No results posted yet for this study

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.

Conditions

  • Diffuse Large B Cell Lymphoma Refractory
  • Diffuse Large B-cell Lymphoma Recurrent

Interventions

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

Sponsors & Collaborators

  • Roche Pharma AG

    collaborator INDUSTRY

  • Fondazione Italiana Linfomi - ETS

    lead OTHER

Principal Investigators

  • Monica Balzarotti, MD · Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas - Rozzano (MI)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-31
Primary Completion
2029-01-31
Completion
2029-01-31

Countries

  • Italy

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05966233 on ClinicalTrials.gov