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New treatment option for Richter Syndrome
Official title Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
ClinicalTrials.gov ID: NCT04679012
What this study is testing
What is Polatuzumab Vedotin?
Polatuzumab Vedotin is an investigational medicine, given as an once-weekly infusion into a vein, being studied as a potential treatment for richter syndrome.
Also referred to as Polivy.
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
- This study evaluates the effectiveness and safety of Polatuzumab vedotin plus infusional chemoimmunotherapy containing rituximab, etoposide, prednisone, cyclophosphamide and hydroxydaunorubicin. This is a single arm study.
- Phase 2: a mid-size study of how well it works
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
- Subject must have confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL) based upon 2018 International Workshop on CLL (IwCLL) criteria, with...
- Subject must be ≥18 years of age.
- Subject must be able to sign informed consent
- Ability and willingness to comply with the study protocol procedures
- Life expectancy of at least 24 weeks
You likely can't join if
- Diagnosis of Richter's Transformation not of DLBCL subtype (including but not limited to Hodgkin lymphoma, PLL)
- Prior therapy targeting Richter's transformation.
- Any subject that initiates a targeted agent such as BTKi, venetoclax, or PI3K prior to enrollment (Continuation of a targeted CLL directed therapy...
- Subject has undergone an allogeneic stem cell transplant for CLL within 6 months of study entry.
- Subject has an active or presumed secondary malignancy at time of enrollment. A subject will be eligible if a previous malignancy was treated with...
- Subject is known to be positive for HIV.
See the full eligibility criteria
- Subject must have confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL) based upon 2018 International Workshop on CLL (IwCLL) criteria, with biopsy proven Richter's Transformation to a DLBCL subtype.
- Subject must be ≥18 years of age.
- Subject must be able to sign informed consent
- Ability and willingness to comply with the study protocol procedures
- Life expectancy of at least 24 weeks
- Subject must have an Eastern Cooperative Oncology Group performance status of ≤2.
- Subject must have measurable disease with atleast on LN\>- 1.5cm in longest diameter
- Subject must have adequate bone marrow function and meet the below thresholds prior to treatment.
- Absolute neutrophil count of ≥1000 cell/uL
- Hemoglobin ≥ 7 g/dL
- Platelet count ≥ 30,000 cells/uL- people may receive growth factor or transfusion support no less than 7 days prior to enrollment or C1 D1.
- Subject must have adequate organ function and meet the thresholds below:
- Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). people with Gilbert's disease will be granted exception to this rule.
- Creatinine clearance \>30 ml/min/1.73m2 as calculated by the MDRD equation.
- Ejection fraction ≥ 50% measured by transthoracic echocardiogram or MUGA scan
- For women of childbearing potential: agreement to remain abstinent or use of contraceptive methods that result in a failure rate of \< 1% per year during the treatment period and for at least 12 months after the last...
- A woman is considered to be of childbearing potential if she is post-menarcheal, has not reached a postmenopausal state (i.e. ≥ 12 months of amenorrhea with no identified cause other than menopause) and has not...
- Acceptable forms of contraception are bilateral tubal ligation, male sterilization, or copper intrauterine devices.
- For women considered to have childbearing potential a negative serum pregnancy test within 7 days prior to study enrollment and dosing is required.
- For men, agreement to remain abstinent, or to use a condom plus an additional contraceptive method during the treatment period and for at least 5 months after the last dose of study drug.
- Men must agree not to donate sperm during that period of time. Male patients interested in preservation of fertility should be advised to sperm bank prior to enrollment and treatment initiation.
- Diagnosis of Richter's Transformation not of DLBCL subtype (including but not limited to Hodgkin lymphoma, PLL)
- Prior therapy targeting Richter's transformation.
- Any subject that initiates a targeted agent such as BTKi, venetoclax, or PI3K prior to enrollment (Continuation of a targeted CLL directed therapy such as a BTKi, venetoclax, or PI3K will be permitted as a bridge...
- Subject has undergone an allogeneic stem cell transplant for CLL within 6 months of study entry.
- Subject has an active or presumed secondary malignancy at time of enrollment. A subject will be eligible if a previous malignancy was treated with curative intent and there is no evidence of disease recurrence for the...
- Subject is known to be positive for HIV.
- Active hepatitis C or hepatitis B defined by positive PCRs for viral DNA/RNA. people with a positive Hep B core antibody and negative PCR, are allowed to enroll (prophylaxis is strongly encouraged and monthly monitoring...
- Subject has baseline ≥ Grade 2 or greater peripheral neuropathy.
- History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
- Clinical evidence or known central nervous system involvement with transformed large cells
- Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results
- Significant cardiovascular disease (such as New York Heart Association Class III or IV cardiac disease, congestive heart failure, myocardial infarction within the previous 6 months, unstable arrhythmias, or unstable...
- Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment or any major episode of infection requiring treatment with intravenous...
- Major surgery within 4 weeks before the start of Cycle 1 day 1. Superficial lymph node biopsies or laprascopic lymph node biopsies are exclusionary to this rule.
The study team makes the final eligibility decision.
Where it's taking place
- New York, New York, United States
- Columbus, Ohio, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to 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 New York, New York, United States; Columbus, Ohio, United States. 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.