R-DHAP vs POLA-R-DHAP Followed by Autologous Transplant as First Salvage Treatment in Patient Wit… (NCT05966233) | Clinical Trial Compass
WithdrawnPhase 2
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
Stopped: Sponsor decision
Italy0Started 2024-01
Plain-language 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.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Histologically documented diagnosis of Diffuse Large B-Cell Lymphoma Not otherwise specified (DLBCL-NOS) as defined in the 2022 edition of the World Health Organization (WHO) classification; are also admitted documented diagnosis of:
✓. Known availability of biopsy material (at relapse/refractory or previous most recent). Re-biopsy highly encouraged even if not mandatory. Central pathology review required, but not mandatory for registration and treatment start;
✓. Relapse or refractoriness after the first line R-chemo (R-CHOP o similar). Previous treatment with polatuzumab containing regimen is allowed as per clinician judgment;
✓. CAR-T not indicated or unavailable;
✓. Age 18-70 years. sGA mandatory for patients 65-70 years old: only category FIT admitted \[20\] (see Appendix A);
✓. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2 if not related to lymphoma disease (see Appendix B);
✓. Measurable disease ≥ 1.5 cm in longest diameter, and measurable in 2 perpendicular dimensions;
✓. Normal blood count defined as: neutrophils at least 1.500/mmc, platelets at least 75.000/mmc, haemoglobin at least 8,0 g/dL with transfusion independence, unless abnormalities due to underlying disease (bone marrow involvement), at the moment of signing informed consent;
Exclusion criteria
✕. Any histology other than DLBCL
✕. Primary mediastinal lymphoma (PMBCL)
What they're measuring
1
Progression free survival (PFS)
Timeframe: From treatment start up to 30 months (6 months treatment period and 24 months of follow-up)