IRB #

STUDY00017566

Title

A Phase 1 Dose Escalation, Open-Label Study of Venetoclax in Combination with Navitoclax and Chemotherapy in Subjects with Relapsed/Refractory Acute Lymphoblastic Leukemia or Relapsed/Refractory Lymphoblastic Lymphoma

Principal Investigator

Jessica Leonard

Study Purpose

The purpose of this study is to address the following primary questions:
- Is venetoclax in combination with navitoclax safe? How well do they work for your cancer?
- Is venetoclax and navitoclax in combination with chemotherapy safe? How well do they work all together for your cancer?
- What side effects are caused by different doses of the combination of venetoclax, navitoclax and chemotherapy?
- How much are venetoclax and navitoclax absorbed in the body at different times after taking them? This is called pharmacokinetics.
- How many participants move on to stem cell transplants?
- Are there biomarkers (substances such as cells, proteins, DNA) found in the blood, bone marrow, or tissue that may show the effects or progression of the cancer and how your cancer is reacting to venetoclax and navitoclax?
- Can we measure minimal residual disease (the level of disease in your blood and bone marrow)?

Medical Condition(s)

Acute Lymphoblastic Leukemia, Lymphomblastic Lymphoma

Eligibility Criteria

-Age 4 or older
-Have Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
-Your disease has relapsed (come back) after treatment or is refractory (has not responded to treatment)

Age Range

4 - 45

Healthy Volunteers Needed

No

Duration of Participation

Your participation in this study may last up to 9 months. After that time, your investigator may keep you on venetoclax and navitoclax if you are still benefitting from treatment. You will receive study treatment until your disease worsens, you can no longer tolerate study treatment, or until you meet any of the criteria for stopping the study. After completing the study, you will be asked to provide information such as status on your disease and whether any new therapies are taken.

Minors Included

Yes

Contact

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

Sponsor

AbbVie, Inc.

Recruitment End

12/31/2027

Compensation Provided

No


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