OncoMatch/Clinical Trials/NCT04679012
Polatuzumab Vedotin in Combination With Chemotherapy in Subjects With Richter's Transformation
Is NCT04679012 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments for richter syndrome.
Treatment: Polatuzumab Vedotin · Rituximab · Etoposide · Prednisone · Cyclophosphamide · Hydroxydaunomycin — 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. Enrolled patients will receive up to six cycles (21-day cycles) of therapy. While on study, subjects will be monitored weekly until end of treatment, then followed for 52 weeks or until disease progression or discontinuation due to toxicity or death. After completion of the 52-week follow-up/End of study visit, Subjects will be followed for an additional 104 week period, with an assessment occurring every 12 weeks to evaluate survival outcomes and next line of treatments only.
Check if I qualifyExtracted eligibility criteria
Cancer type
Chronic Lymphocytic Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Cannot have received: therapy targeting Richter's transformation
Prior therapy targeting Richter's transformation.
Cannot have received: targeted agent (BTK inhibitor, venetoclax, PI3K inhibitor)
Exception: 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
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)
Cannot have received: allogeneic stem cell transplant
Exception: allowed if >6 months prior to study entry
Subject has undergone an allogeneic stem cell transplant for CLL within 6 months of study entry.
Lab requirements
Blood counts
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.
Kidney function
Creatinine clearance >30 ml/min/1.73m2 as calculated by the MDRD equation.
Liver function
Total bilirubin ≤ 1.5 times the upper limit of normal (ULN). Subjects with Gilbert's disease will be granted exception to this rule.
Cardiac function
Ejection fraction ≥ 50% measured by transthoracic echocardiogram or MUGA scan
Subject must have adequate bone marrow function and meet the below thresholds prior to treatment. Subject must have adequate organ function and meet the thresholds below
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Mount Sinai- Icahn School of Medicine · New York, New York
- Columbia University Medical Center · New York, New York
- Weill Cornell Medicine · New York, New York
- Ohio state University · Columbus, Ohio
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