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New treatment option for Plasmablastic Lymphoma
Official title Study to Evaluate Combined Treatment of Daratumumab, Bortezomib and Dexamethasone in PBL Patients.
ClinicalTrials.gov ID: NCT04915248
What this study is testing
What is Daratumumab?
Daratumumab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for plasmablastic lymphoma.
Also referred to as Daratumumab sc.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 18 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Histologically confirmed plasmablastic lymphoma according to WHO 2017, CD38-positive by immunohistochemistry (≥5% of positive cells) Local diagnosis...
- Patients with plasmablastic lymphoma relapsed or refractory:
- after at least one line of conventional-dose chemotherapy followed or not by autologous stem cell transplantation;
- after at least one line of conventional-dose chemotherapy and not eligible for salvage autologous or allogeneic transplantation;
- ECOG Performance Status ≤ 3;
You likely can't join if
- Histologic diagnosis different from confirmed plasmablastic lymphoma according to WHO 2017 and/or CD38 expression \< 5% of positive cells
- CNS involvement
- Patients with known hypersensitivity to the investigational drug or to product components or severe allergic or anaphylactic reactions to humanized...
- Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy including targeted small...
- Concomitant Kaposi sarcoma; however, patients with only skin involvement of KS can be included.
- Subject is:
See the full eligibility criteria
- Histologically confirmed plasmablastic lymphoma according to WHO 2017, CD38-positive by immunohistochemistry (≥5% of positive cells) Local diagnosis of PBL and local CD38 assessment ≥5% will suffice for enrollment and...
- Patients with plasmablastic lymphoma relapsed or refractory:
- after at least one line of conventional-dose chemotherapy followed or not by autologous stem cell transplantation;
- after at least one line of conventional-dose chemotherapy and not eligible for salvage autologous or allogeneic transplantation;
- ECOG Performance Status ≤ 3;
- Age ≥ 18 years;
- Both HIV-negative and HIV-positive patients are eligible;
- HIV infection responsive to ongoing cART (combination antiretroviral therapy);
- At least one measurable disease lesion identifiable by imaging:
- A nodal lesion must be at least 11 mm x 11 mm OR ≥ 16 mm in the greatest transverse diameter (regardless of short axis measurement).
- An extranodal lesion must be at least 10 mm x 10 mm.
- Women of childbearing potential (WOCBP) and men must agree to use effective contraception if sexually active. This applies for the time period between signing of the informed consent form and 7 months (for women) o 4...
- Subject understands and voluntarily signs and dates an informed consent form approved by an Independent Ethics Committee (IEC), prior to the initiation of any screening or study-specific procedures
- Subject must be able to adhere to the study visit schedule and other protocol requirements
- Histologic diagnosis different from confirmed plasmablastic lymphoma according to WHO 2017 and/or CD38 expression \< 5% of positive cells
- CNS involvement
- Patients with known hypersensitivity to the investigational drug or to product components or severe allergic or anaphylactic reactions to humanized products
- Subject has received any anti-cancer therapy including chemotherapy, immunotherapy, radiotherapy, investigational therapy including targeted small molecule agents within 14 days prior to the first dose of study drug
- Concomitant Kaposi sarcoma; however, patients with only skin involvement of KS can be included.
- Subject is:
- Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]. people with resolved infection (i.e., people who are HBsAg negative but positive for antibodies to hepatitis B core...
- Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy)
- Any history of another cancer during the last 5 years with the exception of non-melanoma skin tumors, in situ cervical carcinoma, or in situ breast cancer treated with curative intent with no history of metastatic...
- Chronic or ongoing active infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis or tuberculosis. Drugs for HIV treatment are...
- Active ongoing infection from SARS-CoV-2.
- Screening laboratory values (due to causes different than lymphoma):
- Absolute neutrophil count (ANC) \<1.0 x 109/L (unless secondary to documented marrow involvement by lymphoma)
- Platelet count \<75 x 109/L
- Hemoglobin \< 7.5 g/dL
- Alanine aminotransferase (ALT) and/or Aspartate aminotransferase (AST) \> 3.5 times the upper limit of normal (ULN)
- Alkaline phosphatase \> 3.5 times ULN
- Bilirubin \> 2 times x ULN (unless bilirubin rise is due to Gilbert's syndrome or of non-hepatic origin)
- Serum Creatinine Clearance \< 20 ml/h
- Subject has clinically significant cardiac disease, including:
- Myocardial infarction within 6 months before date of registration, or unstable or uncontrolled disease/condition related to or affecting cardiac function (e.g., unstable angina, congestive heart failure, New York Heart...
- Cardiac arrhythmia (Common Terminology Criteria for Adverse Events [CTCAE] current version Grade 2 or higher) or clinically significant ECG abnormalities. Screening 12-lead ECG showing a baseline QT interval as...
- Evidence of any other clinically significant uncontrolled condition(s)
- Significant history of neurologic, psychiatric, endocrinological, metabolic, immunologic, or hepatic disease that would preclude participation in the study or compromise ability to give informed consent
- Breastfeeding women or women with a positive pregnancy test at screening
The study team makes the final eligibility decision.
Where it's taking place
- Ancona, Italy
- Aviano, Italy
- Brescia, Italy
- Florence, Italy
- Miano, Italy
- Milan, Italy
- Monza, Italy
- Naples, Italy
- Padova, Italy
- Palermo, Italy
- Pavia, Italy
- Reggio Emilia, Italy
- Roma, Italy
- Terni, Italy
- Torino, Italy
- Treviso, Italy
- Verona, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 18 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ancona, Italy; Aviano, Italy; Brescia, Italy; Florence, Italy; Miano, Italy; Milan, Italy and 11 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.