Study of Venetoclax Plus DA-EPOCH-R for the Treatment of Aggressive B-Cell Lymphomas

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Weill Medical College of Cornell University
Study ID
NCT03036904
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Venetoclax — DRUG
    Venetoclax will be administered orally on days 3-12 in cycle 1, and days 1-10 with all subsequent cycles except dose level -1. If dose level -1 is required, venetoclax will be administered on days 3-7 in cycle 1 and 1-5 with subsequent cycles.
  • Rituximab — DRUG
    Rituximab will be administered as an IV infusion at 375 mg/m2 on day 1 of each cycle of DA-EPOCH-R, immediately prior to the start of chemotherapy. Oral pre-medication 650 mg of acetaminophen and 50-100 mg diphenhydramine hydrochloride will be administered 30 to 60 minutes prior to starting each infusion of rituximab. The first rituximab infusion should be started at 50 mg/hr, and increased in 50-mg/hr increments every 30 minutes to a maximum rate of 400 mg/hr. If this rate of escalation is well tolerated the second and subsequent infusions can begin at a rate of 100 mg/hr and increase in 100 mg/hr increments every 30 minutes to a maximum of 400 mg/hr. CAUTION: DO NOT ADMINISTER AS AN INTRAVENOUS PUSH OR BOLUS.
  • 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.
  • Vincristine Sulfate — DRUG
    Vincristine Sulfate 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.
  • 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.
  • 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.
  • Doxorubicin Hydrochloride — DRUG
    Doxorubicin Hydrochloride 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 is a phase I, open label, single-arm, multi-center, dose-finding study of venetoclax in combination with DA-EPOCH-R in patients with aggressive B-Cell Lymphomas.

Key Dates

Start date
Feb 6, 2017
Status verified
Aug 2022
Primary completion
Nov 11, 2021
Completion
Nov 11, 2021

Study Design

Enrollment
31 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Venetoclax plus DA-EPOCH-R
    Venetoclax will be given in conjunction with 6 cycles of DA-EPOCH-R (doxorubicin hydrochloride, etoposide, vincristine sulfate, cyclophosphamide, prednisone, rituximab). The dosing schedule and regimen for DA-EPOCH-R will follow established protocols. Venetoclax will be administered days 1-10 of each 21-day cycle, with the exception of cycle 1, during which venetoclax dose will commence on day 3 and continue through day 12, so as to clarify attribution of any observed TLS and/or infusion reactions, and minimize tumor lysis syndrome (TLS) risk.

Primary Outcome Measure

Determination of the maximal tolerated dose (MTD) [ Time Frame: Approximately 24 months ]

Locations (6)

FacilityCityStateZIPSite coordinators
Massachusetts General Hospital Cancer CenterBostonMassachusetts02284-
Washington University School of MedicineSt LouisMissouri63110-
Weill Cornell MedicineNew YorkNew York10065-
Ohio State University Medical CenterColumbusOhio43210-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
MD Anderson Cancer CenterHoustonTexas77030-

Find similar trials in Boston, MA

By research site
Massachusetts General Hospital Cancer Center· Boston, MAWashington University School of Medicine· St Louis, MOWeill Cornell Medicine· New York, NYOhio State University Medical Center· Columbus, OHFox Chase Cancer Center· Philadelphia, PAMD Anderson Cancer Center· Houston, TX

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