Back to search results

Polatuzumab Vedotin with Chemotherapy for Richter's Transformation

This study is looking at the effectiveness and safety of a treatment combination for Richter's Transformation, a type of aggressive lymphoma that can develop in people with chronic lymphocytic leukemia (CLL). The treatment involves Polatuzumab Vedotin, an immunotherapy drug, along with chemotherapy drugs: Rituximab, Etoposide, Prednisone, and Cyclophosphamide. Researchers want to see how many people achieve a complete metabolic remission or complete remission after treatment. You may be able to join if you are at least 18 years old, have a confirmed diagnosis of CLL or small lymphocytic lymphoma (SLL) with biopsy-proven Richter's Transformation to a DLBCL subtype. The study plans to enroll 20 participants, but its current status is unclear.

Study design
This is an open-label, single-arm study, meaning all participants receive the same treatment and everyone involved knows what treatment is being given. It aims to enroll 20 participants.
What's involved
You would receive up to six cycles of therapy, with each cycle lasting 21 days. You will be monitored weekly until the end of treatment, then followed for 52 weeks, and then for an additional 104 weeks to check survival and future treatments.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will be followed for 52 weeks, and then for an additional 104 weeks to assess survival and next treatments.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04679012

Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation

Recruiting
PHASE2Ages 18+InterventionalTreatment
Weill Medical College of Cornell University
~20 participants
Updated 2025-10-07 on ClinicalTrials.gov
What's tested:Polatuzumab VedotinRituximabEtoposidePrednisoneCyclophosphamideHydroxydaunomycin

At a glance

Recruiting sites
4 of 4 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete metabolic remission/complete remission (CMR/CR) rate of subjects at end of treatment (EOT)
Measured over 19 weeks

Conditions

Richter Syndrome
Chronic Lymphocytic Leukemia

Explore related trials

Richter Syndrome

NCT04679012

Where you'd take part

This study runs at 4 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Weill Cornell Medicine

    New York, New Yorkstudy coordinator listed

    Recruiting

  • Columbia University Medical Center

    New York, New Yorkno site contact published

    Recruiting

  • Mount Sinai- Icahn School of Medicine

    New York, New Yorkno site contact published

    Recruiting

  • Ohio state University

    Columbus, Ohiono site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • John Allan, M.D. · PRINCIPAL_INVESTIGATOR · Weill Medical College of Cornell University

Who to contact

Amelyn Rodriguez, R.N.
[email protected]
2127461362
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Want this trial checked against your situation?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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- Subjects 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). Subjects 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 dose of study drug.
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 undergone surgical sterilization (removal of ovaries and or uterus)
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.

Exclusion

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 through screening but add on therapies or change in therapy will be exclusionary. These continuation therapies will be permitted up 72 hours prior to study initiation. Bridging therapy with steroid up to equivalent of 40mg of Dexamethasone daily will be allowed prior to study treatment and can be continued up to 24 hours prior to study treatment)
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 past 3 years. Non-melanomatous and cervical squamous cell cancers are an exception and if excised will be allowed to enroll regardless of timing of excision.
Subject is known to be positive for HIV.
Active hepatitis C or hepatitis B defined by positive PCRs for viral DNA/RNA. Subjects with a positive Hep B core antibody and negative PCR, are allowed to enroll (prophylaxis is strongly encouraged and monthly monitoring of Hep B PCR is mandatory).
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 angina)
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 antibiotics or hospitalization within 4 weeks before Cycle 1 day 1.
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.

What this trial measures

  • Complete metabolic remission/complete remission (CMR/CR) rate of subjects at end of treatment (EOT)19 weeks

    Percentage of subjects who achieve CMR/CR on study.