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

  • STATUS
    Recruiting
  • End date
    Jun 3, 2024
  • participants needed
    20
  • sponsor
    Weill Medical College of Cornell University
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Updated on 3 January 2022
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platelet count
cyclophosphamide
rituximab
etoposide
neutrophil count

Summary

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.

Description

This is an open label, single arm, phase II investigator initiated clinical trial, evaluating efficacy and safety of Polatuzumab vedotin added to a modified infusional dose adjusted R-EPOCH like regimen, given on an inpatient basis, every 21 days, in subjects with Richter's Transformation.

Details
Condition Richter Syndrome, Chronic Lymphocytic Leukemia
Treatment Rituximab, cyclophosphamide, etoposide, prednisone, Polatuzumab Vedotin, Hydroxydaunomycin, Hydroxydaunomycin
Clinical Study IdentifierNCT04679012
SponsorWeill Medical College of Cornell University
Last Modified on3 January 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

Subject must have confirmed diagnosis of CLL 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 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
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 Criteria

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
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