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

Part of paid clinical trials in New York, New York.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT04679012
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Polatuzumab Vedotin — DRUG
    Polatuzumab vedotin will be administered as an IV infusion at 1.8mg/kg on Day 1 of each cycle, every 21 days.
  • Rituximab — DRUG
    Rituximab will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
  • Etoposide — DRUG
    Etoposide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
  • Prednisone — DRUG
    Prednisone will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. Prednisone will be given orally.
  • Cyclophosphamide — DRUG
    Cyclophosphamide will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.
  • Hydroxydaunomycin — DRUG
    Hydroxydaunomycin will be obtained from commercial supply, and will be given for a total of 6 cycles for all patients. The drug will be given by IV route.

Study Details

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.

Key Dates

Start date
Sep 24, 2021
Status verified
Oct 2025
Primary completion
Sep 30, 2026
Completion
Sep 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Polatuzumab vedotin plus R-EPCH
    Polatuzumab vedotin will be given in conjunction with 6 cycles of R-EPCH (rituximab, etoposide, prednisone, cyclophosphamide, hydroxydaunorubicin). The dosing schedule and regimen for R-EPCH will follow established protocols. Polatuzumab vedotin will be administered on Day 1 of each 21-day cycle.

Primary Outcome Measure

Complete metabolic remission/complete remission (CMR/CR) rate of subjects at end of treatment (EOT) [ Time Frame: 19 weeks ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Andrew Lipsky, MD
Andrew Lipsky, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai- Icahn School of MedicineNew YorkNew York10029
Suchitra Sundaram, MD
Suchitra Sundaram, MD (PRINCIPAL_INVESTIGATOR)
Weill Cornell MedicineNew YorkNew York10065
Amelyn Rodriguez, R.N.
[email protected]
2127461362
Katherine Greig, R.N.
[email protected]
2127466738
John Allan, M.D. (PRINCIPAL_INVESTIGATOR)
Ohio state UniversityColumbusOhio43210
Adam Kittai
Adam Kittai, MD (PRINCIPAL_INVESTIGATOR)

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