IRB #

STUDY00017005

Title

IIT Phase I Study of pevonedistat (MLN4924, TAK924) in combination with ibrutinib in patients with relapsed/refractory chronic lymphocytic leukemia and non-Hodgkin lymphoma

Principal Investigator

Alexey Danilov

Study Purpose

The purpose of this study is find a safe and tolerable dose of pevonedistat when given in combination with ibrutinib, and to identify what effects, good or bad, treatment with these two drugs has on relapsed/refractory chronic lymphocytic leukemia (CLL) and non-Hodgkin lymphoma (NHL).

Medical Condition(s)

Chronic lymphocytic leukemia (CLL)
Non-Hodgkin lymphoma (NHL)
Relapsed
Refractory

Eligibility Criteria

Participants must be 18 years or older, and have a diagnosis of relapsed/refractory CLL or NHL.

Key exclusion criteria includes:
- Intolerance to ibrutinib
- Chronic treatment with BCRP inhibitors (cyclosporine, eltrombopag)
- Chronic use of prednisone exceeding 20mg/day or other equivalent corticosteroids
- Evidence of, or active treatment for, graft-versus-host disease
- Uncontrolled immune hemolysis or thrombocytopenia
- Known cardiopulmonary disease
- History of HIV infection or known/suspected active hepatitis B and C infection
- Pregnant or breastfeeding

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Participants will receive 18 cycles (approximately 1 year) of treatment. If minimal residual disease has not been reached at the end of 18 cycles, a participant may continue on ibrutinib until disease progression. After treatment is finished, the investigator will continue to follow participants for side effects every 3 to 6 months until disease progression or death.

Minors Included

No

Contact

Clinical Trials Information Line
503-494-1080
trials@ohsu.edu

Sponsor

Takeda Global Research & Development Center, Inc.

Recruitment End

06/18/2021

Compensation Provided

No


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