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

Start date
Mar 8, 2017
Status verified
Aug 2025
Primary completion
Dec 1, 2024
Completion
Dec 1, 2027

Study Design

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

Arms

  • Experimental: VR-EPOCH
    * Standard chemotherapy regimen, DA-EPOCH-R, with a novel oral Bcl-2 inhibitor, venetoclax will be administered to patients * 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
  • Experimental: VR-CHOP
    * Standard chemotherapy regimen, R-CHOP, with a novel oral Bcl-2 inhibitor, venetoclax will be administered to patients * 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

Primary Outcome Measure

Rate of Complete Response by 2008 IW-CLL Response Criteria [ Time Frame: 2 years ]

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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