A Phase II Study of Venetoclax in Combination With Dose-adjusted EPOCH-R or R-CHOP for Patients With Richter's Syndrome

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Dana-Farber Cancer Institute
Study ID
NCT03054896
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Richter Syndrome

Eligibility Criteria

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

Interventions

  • Venetoclax — DRUG
    Venetoclax is an Antineoplastic Agent; BCL-2 Inhibitor
  • DA-EPOCH-R — OTHER
    Intensive chemotherapy regiment
  • R-CHOP — OTHER
    Intensive chemotherapy regiment

Study Details

This research study is evaluating the combination of a study drug, venetoclax, and a standard chemotherapy regimen, R-EPOCH or R-CHOP, as a possible treatment for Richter's Syndrome. The drugs involved in this study are: * Venetoclax * R-EPOCH: * Rituximab * Etoposide * Prednisone * Vincristine Sulfate (Oncovin) * Cyclophosphamide * Doxorubicin Hydrochloride (Hydroxydaunomycin) * R-CHOP: * Rituximab * Cyclophosphamide Vincristine * Doxorubicin Hydrochloride (Hydroxydaunomycin) * Sulfate (Oncovin) * Prednisone

Key Dates

First listed
Feb 16, 2017
Start date
Mar 8, 2017
Status verified
Jun 2026
Primary completion
Dec 24, 2025
Completion
Dec 1, 2027

Study Design

Enrollment
69 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VR-EPOCH (Cohort 1)
    * Standard chemotherapy regimen, DA-EPOCH-R * Chemotherapy cycles will be administered approximately every 3 weeks * Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg
  • Experimental: VR-CHOP (Cohort 2)
    * Standard chemotherapy regimen, R-CHOP * Chemotherapy cycles will be administered approximately every 3 weeks * Initial venetoclax dose ramp-up will be done in a condensed fashion over approximately 5 days, followed by continuous daily dosing of 400mg

Primary Outcome Measure

3-month Rate of Complete Response (CR) [ Time Frame: Relevant to this endpoint, it is at 3 month. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Dana Farber Cancer InstituteBostonMassachusetts02215-
Ohio State UniversityColumbusOhio43210-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Boston, MA

By research site
Dana Farber Cancer Institute· Boston, MAOhio State University· Columbus, OHMD Anderson Cancer Center· Houston, TX

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