TAK-659 in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 122

Inclusion Criteria

1. Male or female patients aged 18 years or older.
2. Patients must have histologically confirmed DLBCL, including de novo disease or transformed disease from indolent NHL. High-grade B-cell lymphoma with MYC and BCL-2 and/or BCL-6 translocations (double-hit
DLBCL under DLBCL, NOS, based on the 2008 WHO classification criteria) is not eligible for this study.
a. Local pathology review for histological confirmation:
- A formalin-fixed, paraffin-embedded (FFPE) tumor block or appropriately stained slides from a fresh biopsy is required.
3. Relapsed or refractory to =2 prior lines of chemotherapy based on standard of care with certain requirements for prior therapy.
4. For patients who have relapsed or progressed after achieving a response, documented, investigator-assessed relapse or progression after the last treatment is required.
5. Must have FDG-PET–avid measurable disease that meets the size criteria per IWG as assessed on cross-sectional imaging by CT/MRI.
6. ECOG performance status score of 0 or 1.
7. Life expectancy of >3 months
8. Patients must have adequate organ function, including the following:
a. Bone marrow reserve: absolute neutrophil count (ANC) =1000/µL, platelet count =75,000/µL (=50,000/µL for patients with bone marrow involvement), and hemoglobin =8 g/dL (red blood cell [RBC] and
platelet transfusion allowed =14 days before assessment).
b. Hepatic: total bilirubin =1.5 times the upper limit of the normal range (ULN); ALT and AST =2.5xULN.
c. Renal: creatinine clearance =60 mL/min either as estimated by the Cockcroft-Gault equation or based on urine collection (12 or 24 hours).
d. Others:
•Lipase =1.5xULN and amylase =1.5xULN with no clinical symptoms suggestive of pancreatitis or cholecystitis.
•Blood pressure =Grade 1 (hypertensive patients are permitted if their blood pressure is controlled to =Grade 1 by hypertensive medications and glycosylated hemoglobin is =6.5%).
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 49
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 73

Exclusion Criteria

1. CNS lymphoma; active brain or leptomeningeal metastases.
2. Known human immunodeficiency virus (HIV)–related malignancy.
3. Systemic anticancer treatment (including investigational agents) less than 3 weeks before the first dose of study treatment.
4. Radiotherapy less than 3 weeks before the first dose of study treatment.
5. Known HIV positive (testing not required).
6. Known hepatitis B surface antigen positive or known or suspected active hepatitis C infection.
7. Prior ASCT within 6 months or prior ASCT at any time without full hematopoietic recovery before Cycle 1 Day 1, or allogeneic stem cell transplant any time.
8. Participants with certain cardiovascular conditions are excluded.
9. Major surgery within 14 days before the first dose of study drug or incomplete recovery from any complications from surgery.
10. Systemic infection requiring parenteral antibiotic therapy or other serious infection (bacterial, fungal, or viral) within 21 days before the first dose of study drug.
11. Treatment with high-dose corticosteroids for anticancer purposes within 7 days before the first dose of TAK-659.
12. Patients with another malignancy within 2 years of study start. Patients with nonmelanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection and are
considered disease-free at the time of study entry.
13. Known gastrointestinal (GI) disease or GI procedure that could interfere with the oral absorption or tolerance of TAK-659.
14. Certain wash-out restrictions before the first dose of study drug on inhibitors of P-gp and/or strong reversible inhibitors of CYP3A, strong CYP3A mechanism-based inhibitors or strong CYP3A inducers and/or Pgp inducers, grapefruit containing food or beverages.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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