Study Stopped
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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
FIL_POLARDHAP
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.
1 other identifier
interventional
N/A
1 country
37
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jan 2024
Longer than P75 for phase_2
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 21, 2023
CompletedFirst Posted
Study publicly available on registry
July 28, 2023
CompletedStudy Start
First participant enrolled
January 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
May 21, 2024
May 1, 2024
5 years
July 21, 2023
May 20, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression free survival (PFS)
Time between the randomization to first documentation of recurrence, progression or death from any cause
From treatment start up to 30 months (6 months treatment period and 24 months of follow-up)
Secondary Outcomes (7)
Event-Free Survival (EFS)
From treatment start up to 30 months (6 months treatment period and 24 months of follow-up)
Complete response rate (CRR)
From treatment start up to end of treatment evaluation (about 6 months)
Overall response rate (ORR)
From treatment start up to end of treatment evaluation (about 6 months)
Overall Survival (OS)
From treatment start up to 30 months (6 months treatment period and 24 months of follow-up)
Incidence and severity of AEs
From start to end of induction treatment evaluation (about 3 months)
- +2 more secondary outcomes
Study Arms (2)
R-DHAP
ACTIVE COMPARATORR-DHAP x4 + autologous transplant/salvage treatment (based on centrally review response)
Pola-R-DHAP
EXPERIMENTALPola-R-DHAP x4 + autologous transplant/salvage treatment (based on centrally review response)
Interventions
* 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
* 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
Eligibility Criteria
You may qualify if:
- 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:
- T-cell/histiocyte-rich large B-cell lymphoma (THRLBCL)
- Epstein-barr virus (EBV)-associated DLBCL
- Double-hit and triple-hit high grade B-cell lymphomas (HGBL DH/TH)
- High-grade B-cell lymphoma, NOS (HGBL)
- Transformed FL not previously untreated
- Follicular large B-cell lymphoma (FLBL, former follicular 3b)
- 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;
- Adequate liver function, assessed by baseline laboratory values; the increase to up to 2.5 ULN for transaminases and up to 1.5 ULN for bilirubin admitted for cases with documented liver involvement by lymphoma;
- +7 more criteria
You may not qualify if:
- Any histology other than DLBCL
- Primary mediastinal lymphoma (PMBCL)
- Known central nervous system lymphoma
- Known history of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- Contraindication to any drug in the chemotherapy regimen
- Left ventricular ejection fraction (LVEF) \< 50%
- Neuropathy ≥ grade 2
- Subject is:
- Seropositive for hepatitis B, defined by a positive test for hepatitis B surface antigen \[HBsAg\]. EXCEPTION: Subjects with serologic findings suggestive of HBV vaccination (HBsAb positivity as the only serologic marker) AND a known history of prior HBV vaccination, do not need to be tested for HBV DNA by PCR
- Known to be seropositive for hepatitis C. EXCEPTION: Patients with presence of HCV antibody, but PCR negative for HCV-RNA are eligible
- Positive for human immunodeficiency virus (HIV) infection
- Any uncontrolled active systemic infection requiring intravenous (IV) antibiotics
- History of stroke or intracranial hemorrhage within the past 6 months.
- History of clinically relevant liver or renal insufficiency; significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, rheumatologic, hematologic, psychiatric, or metabolic disturbances
- Clinically significant cardiovascular disease
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fondazione Italiana Linfomi - ETSlead
- Roche Pharma AGcollaborator
Study Sites (37)
A.O. SS. Antonio e Biagio e Cesare Arrigo, S.C. Ematologia
Alessandria, Italy
AOU Ospedali Riuniti, Clinica di Ematologia
Ancona, Italy
Azienda Ospedaliera S.Giuseppe Moscati, S.C. Ematologia e Trapianto emopoietico
Avellino, Italy
IRCCS Centro di Riferimento Oncologico di Aviano, Divisione di Oncologia e dei Tumori immuto-correlati
Aviano, Italy
IRCCS Istituto Tumori Giovanni Paolo II, U.O.C Ematologia
Bari, Italy
Cliniche Humanitas Gavazzeni, Oncologia
Bergamo, Italy
ASST Spedali Civili di Brescia, Ematologia
Brescia, Italy
Fondazione del Piemonte per l'Oncologia - IRCCS, Ematologia
Candiolo, Italy
Arnas Nuovo Ospedale Garibaldi Nesima, U.O.C. Ematologia
Catania, Italy
A.O. S. Croce e Carle, S.C. di Ematologia e Trapianto di Midollo Osseo
Cuneo, Italy
Azienda Ospedaliera Universitaria Careggi, Unitа funzionale di Ematologia
Florence, Italy
Ospedale Vito Fazzi, Ematologia
Lecce, Italy
ASST Ovest Milanese - Legnano, U.O.C. Ematologia
Legnano, Italy
ASST Grande Ospedale Metropolitano Niguarda, SC Ematologia
Milan, Italy
Istituto Scientifico San Raffaele, Unitа Linfomi - Dipartimento Oncoematologia
Milan, Italy
Ospedale Maggiore Policlinico - Fondazione IRCCS Ca Granda, Ematologia
Milan, Italy
Fondazione IRCCS San Gerardo dei Tintori, Ematologia
Monza, Italy
AOU Maggiore della Caritа di Novara, SCDU Ematologia
Novara, Italy
A.O. Ospedali Riuniti Villa Sofia-Cervello, Divisione di Ematologia
Palermo, Italy
Ospedale S. Maria della Misericordia, Ematologia
Perugia, Italy
P.O. Spirito Santo di Pescara, UOS Dipartimentale - Centro di diagnosi e Terapia dei linfomi
Pescara, Italy
Ospedale Guglielmo da Saliceto, U.O.Ematologia
Piacenza, Italy
AOU Pisana, U.O. Ematologia
Pisa, Italy
A.O.R. "San Carlo", U.O. Ematologia
Potenza, Italy
Ospedale delle Croci, Ematologia
Ravenna, Italy
Azienda Unitа Sanitaria Locale-IRCCS - Arcispedale Santa Maria Nuova, Ematologia
Reggio Emilia, Italy
AO San Giovanni Addolorata, S.C. Ematologia
Roma, Italy
AO Sant Andrea, Ematologia
Roma, Italy
Policlinico Umberto I - Universitа "La Sapienza", Istituto Ematologia -Dipartimento di Medicina Traslazionale e di Precisione
Roma, Italy
Policlinico Universitario Campus Bio-Medico, Ematologia - Trapianto cellule staminali - Medicina Trasfusionale e Terapia cellulare
Roma, Italy
Istituto Clinico Humanitas, U.O. Ematologia
Rozzano, Italy
AOU Senese, U.O.C. Ematologia
Siena, Italy
A.O.U. Citta della Salute e della Scienza di Torino, Ematologia Universitaria
Torino, Italy
A.O.U. Citta della Salute e della Scienza di Torino, S.C.Ematologia
Torino, Italy
Ospedale Ca Foncello, S.C di Ematologia
Treviso, Italy
A.O.C. Panico, U.O.C Ematologia e Trapianto
Tricase, Italy
Azienda Sanitaria Universitaria Giuliano Isontina (ASUGI), SC Ematologia
Trieste, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Monica Balzarotti, MD
Dipartimento di Oncologia Medica ed Ematologia - Istituto Clinico Humanitas - Rozzano (MI)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 21, 2023
First Posted
July 28, 2023
Study Start
January 1, 2024
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Last Updated
May 21, 2024
Record last verified: 2024-05