Combination Chemotherapy and TAK-659 as Front-Line Treatment in Treating Patients With High-Risk Diffuse Large B Cell Lymphoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT03742258
Phase
PHASE1
Status
Completed

Conditions

  • Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma Activated B-Cell Type
  • Diffuse Large B-Cell Lymphoma Germinal Center B-Cell Type
  • Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6 Rearrangements
  • High Grade B-Cell Lymphoma, Not Otherwise Specified
  • T-Cell/Histiocyte-Rich Large B-Cell Lymphoma

Eligibility Criteria

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

Interventions

  • Cyclophosphamide — DRUG
    Given IV
  • Doxorubicin Hydrochloride — DRUG
    Given IV
  • Prednisone — DRUG
    Given PO
  • Rituximab — BIOLOGICAL
    Given IV
  • Spleen Tyrosine Kinase Inhibitor TAK-659 — DRUG
    Given PO
  • Vincristine Sulfate — DRUG
    Given IV

Study Details

The purpose of this research study is to evaluate a new investigational drug, TAK-659, given in combination with standard chemotherapy, for the treatment of Diffuse Large B-cell Lymphoma (DLBCL). ?Investigational? means that TAK-659 has not been approved by the United States Food and Drug Administration (FDA) for use as a prescription or over-the-counter medication to treat a certain condition. The primary purpose of this study is to find the appropriate and safe dose of the study drug to be used in combination with standard chemotherapy for the treatment of your disease and to determine how well the drug works in treating the disease. Other objectives include measuring the amount of the study drug in the body at different times after taking the study drug. Participation in the study is expected to last for up to 3 years after receiving the last dose of the study drug. Patients will receive the study treatment for up to 18 weeks, as long as they are benefitting.

Key Dates

Start date
Mar 13, 2019
Status verified
Jun 2025
Primary completion
Mar 12, 2021
Completion
Feb 8, 2024

Study Design

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

Arms

  • Experimental: TAK-659 60mg + R-CHOP
    Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 1 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: TAK-659 80mg + R-CHOP
    Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 2 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.
  • Experimental: TAK-659 100mg + R-CHOP
    Patients receive rituximab IV, cyclophosphamide IV, doxorubicin hydrochloride IV over 3-5 minutes, and vincristine sulfate IV on day 1, and prednisone PO on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Beginning in cycle 2, patients also receive spleen tyrosine kinase inhibitor TAK-659 Dose Level 3 PO QD on days 1-21. Treatment repeats every 21 days for up to 5 courses in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Maximum Tolerated Dose (MTD) [ Time Frame: The first 21 days after the participant received their first dose of TAK-695 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611-
Northwestern Lake Forest HospitalLake ForestIllinois60045-

Find similar trials in Chicago, IL

By research site
Northwestern University· Chicago, ILNorthwestern Lake Forest Hospital· Lake Forest, IL

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