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RecruitingPhase 2NCT04915248

Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.

An Open Label, Phase 2 Study to Evaluate Activity and Safety of Daratumumab in Combination With Bortezomib and Dexamethasone in Patients With Relapsed or Refractory Plasmablastic Lymphoma (DALYA Trial)

Sponsor

Fondazione Italiana Linfomi - ETS

Enrollment

28 participants

Start Date

Jul 11, 2022

Study Type

INTERVENTIONAL

Conditions

Plasmablastic Lymphoma

Summary

It is an open-label, multicenter, phase II, single arm trial to Evaluate Activity and Safety of Daratumumab in combination with Bortezomib and Dexamethasone in patients about 28 patients with Relapsed or Refractory Plasmablastic lymphoma.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — daratumumab, bortezomib, and dexamethasone — for a rare and aggressive type of blood cancer called plasmablastic lymphoma (PBL) that has returned or stopped responding to prior treatment. **You may be eligible if:** - You have been diagnosed with plasmablastic lymphoma (confirmed by biopsy) that has relapsed or is no longer responding to chemotherapy - You are 18 or older with reasonably good functional status - Your cancer is measurable on imaging - Both HIV-positive and HIV-negative patients may be eligible - You are using effective contraception if you could become pregnant **You may NOT be eligible if:** - Your cancer has spread to the brain or spinal fluid - You have had a serious allergic reaction to any of the study drugs - You have active hepatitis B, hepatitis C, or HIV with detectable virus levels - You had a stem cell transplant within the last 100 days - You have significant heart disease (recent heart attack, severe heart failure, or dangerous heart rhythm) - You have had another cancer in the last 5 years (with some exceptions like treated skin cancer) - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDaratumumab

Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen). Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent.

DRUGBortezomib

Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen). Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent.

DRUGDexamethasone

Induction phase planning one course (cycle 1) of daratumumab as single agent followed by 8 courses (cycles 2-9) of daratumumab in combination with bortezomib and dexamethasone (DVd regimen). Patients achieving at least a SD after induction will be addressed to the maintenance phase, planning a maximum of 6 cycles (cycles 10-15) of daratumumab as single agent.

Locations(18)

A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona

Ancona, Italy

Aviano - IRCCS Centro di Riferimento Oncologico di Aviano - Divisione di Oncologia e dei Tumori immuto-correlati

Aviano, Italy

A.O. Spedali Civili di Brescia - Ematologia

Brescia, Italy

Azienda Ospedaliera Universitaria Careggi - Unità funzionale di Ematologia

Florence, Italy

Milano - ASST Grande Ospedale Metropolitano Niguarda - SC Ematologia

Miano, Italy

Istituto Scientifico San Raffaele, Unità Linfomi - Dipartimento Oncoematologia

Milan, Italy

Monza - ASST MONZA Ospedale S. Gerardo - Ematologia

Monza, Italy

Napoli - AORN - Azienda Ospedaliera dei Colli Monald - U.O.C. Oncologia

Naples, Italy

U.O. Ematologia AO di Padova

Padova, Italy

A.O. Universitaria Policlinico Giaccone Di Palermo

Palermo, Italy

Ematologia IRCCS Policlinico S. Matteo di Pavia

Pavia, Italy

AO Arcispedale S.Maria Nuova Ematologia

Reggio Emilia, Italy

Roma - IRCCS Spallanzani - Servizio di Ematologia in malattie infettive

Roma, Italy

Roma - Ospedale S. Camillo - Ematologia

Roma, Italy

A.O. S. Maria di Terni - S.C. Oncoematologia

Terni, Italy

A.O. Universitaria Citta' Della Salute E Della Scienza Di Torino

Torino, Italy

Struttura Complessa di Ematologia PO TREVISO

Treviso, Italy

AOU Integrata di Verona - U.O. Ematologia

Verona, Italy

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NCT04915248

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