TAK-659 + Chemotherapy for Lymphoma

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Reem Karmali

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Northwestern University

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Reem Karmali

Principal Investigator

Northwestern University

Eligibility Criteria

This trial is for patients with a confirmed diagnosis of high-risk Diffuse Large B-cell Lymphoma (DLBCL), including several subtypes and those transformed from low-grade lymphoma. Participants may have started one cycle of R-CHOP chemotherapy or plan to start it, must have measurable disease on scans, and should not have severe ongoing effects from previous cancer treatments.

Inclusion Criteria

My diagnosis is a specific type of aggressive lymphoma.

I finished my first R-CHOP cycle within the last 21 days or plan to start it after signing up.

My cancer is the ABC/non-GCB type, confirmed by specific tests.

Treatment Details

Interventions

• Cyclophosphamide (Chemotherapy Agent)
• Doxorubicin Hydrochloride (Chemotherapy Agent)
• Prednisone (Corticosteroid)
• Rituximab (Monoclonal Antibody)
• TAK-659 (Spleen Tyrosine Kinase Inhibitor)
• Vincristine Sulfate (Vinca Alkaloid)

Trial Overview The study tests TAK-659 combined with standard chemotherapy (Rituximab, Prednisone, Vincristine Sulfate, Doxorubicin Hydrochloride, Cyclophosphamide) in treating DLBCL. It aims to find the safe dose level and effectiveness of TAK-659 over an up-to-18-week treatment period within a total participation time frame of up to 3 years.

Participant Groups

Group I: TAK-659 80mg + R-CHOP Experimental Treatment 6 Interventions

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.

Group II: TAK-659 60mg + R-CHOP Experimental Treatment 6 Interventions

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.

Group III: TAK-659 100mg + R-CHOP Experimental Treatment 6 Interventions

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.

Cyclophosphamide is already approved in Canada, Japan for the following indications:

Approved in Canada as Neosar for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma
• Rheumatoid arthritis

Approved in Japan as Endoxan for:

• Breast cancer
• Ovarian cancer
• Multiple myeloma
• Leukemia
• Lymphoma

Who Is Running the Clinical Trial?

Northwestern University

Lead Sponsor

Trials

1,674

Recruited

989,000+

Dr. Jeffrey Sherman

Northwestern University

Chief Medical Officer

MD from Northwestern University

Dr. Alicia Löffler

Northwestern University

Chief Executive Officer since 2010

PhD from the University of Massachusetts at Amherst, post-doctoral training at Caltech

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School