Combination Chemotherapy, Rituximab, and Ixazomib Citrate in Treating Patients With Non-Hodgkin Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT02481310
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

  • Adult Burkitt Lymphoma
  • B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Burkitt Lymphoma
  • Diffuse Large B-Cell Lymphoma
  • MYC Gene Mutation
  • Plasmablastic Lymphoma

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Cytarabine — DRUG
    Given IT or intraventricularly
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Etoposide — DRUG
    Given IV
  • Ixazomib Citrate — DRUG
    Given PO
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Methotrexate — DRUG
    Given IT or intraventricularly
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Therapeutic Hydrocortisone — DRUG
    Given IT or intraventricularly
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

The purpose of this study is to evaluate the effects, good and bad of a new drug called ixazomib (also called MLN9708), when it is given along with a common treatment combination, called Dose-Adjusted EPOCH-R (DA-EPOCH-R, for short). This is a type of study called a phase I/II trial. In the phase I part, the dose of the study drug (ixazomib) will be adjusted (either up or down) to find the maximum (highest) dose that does not cause excessive (too many) harmful side effects. In the phase II part, this dose of ixazomib will be given at the maximum safe dose found in phase I. In both phase I and II, DA-EPOCH-R will be adjusted between cycles depending on how blood cell levels are affected between cycles. Ixazomib is considered investigational because it is not approved by the U.S. Food and Drug Administration (FDA). DA-EPOCH-R is a combination chemotherapy treatment developed over the last 14-15 years, and each of the drugs in this regimen is FDA-approved and considered part of the standard of care.

Key Dates

Start date
Oct 28, 2015
Status verified
Feb 2022
Primary completion
Sep 26, 2020
Completion
Jul 31, 2024

Study Design

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

Arms

  • Experimental: Treatment (combination chemotherapy, rituximab, ixazomib)
    INDUCTION: Patients receive ixazomib citrate PO on day 1 and day 8 or 15; etoposide IV, vincristine sulfate IV, and doxorubicin hydrochloride IV continuously over 96 hours on days 1-4; prednisone PO BID on days 1-5; rituximab IV 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 on day 1; and cyclophosphamide IV over 90 minutes on day 5. CNS PROPHYLAXIS: Patients with a negative LP receive methotrexate IT once per course. Patients with a positive LP receive methotrexate IT or intraventricularly OR cytarabine IT or intraventricularly OR methotrexate IT or intraventricularly, cytarabine IT or intraventricularly, and therapeutic hydrocortisone IT or intraventricularly. MAINTENANCE: Patients not treated with consolidative SCT, receive ixazomib citrate PO BID on days 1, 8, and 15. Treatment repeats every 28 days for up to one year in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

To Determine the Recommended Phase II Dose (RP2D) of Ixazomib in Combination With DA-EPOCH-R. [ Time Frame: The first 21 days of treatment ]

Locations (5)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
Tufts UniversityMedfordMassachusetts02155-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer CenterClevelandOhio44195-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILTufts University· Medford, MARutgers Cancer Institute of New Jersey· New Brunswick, NJCleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center· Cleveland, OHMedical College of Wisconsin· Milwaukee, WI

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