Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL

• Status: Active, not recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the optimal dosing scheme for the combination of ibrutinib with ABT-199 for the treatment of relapsed or refractory mantle cell lymphoma (MCL).

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Craig Portell, MD
• Collaborator: AbbVie
• Treatments: Venetoclax

Criteria

Inclusion Criteria:

1. Diagnosed with Mantle Cell Lymphoma and has had at least one chemotherapy.

2. Subjects must have measurable or evaluable disease.

3. ECOG Performance Status of 0-2.

4. Must be referred for treatment with ibrutinib.

5. Must have adequate organ function.

Exclusion Criteria:

1. Subject is pregnant.

2. Prior malignancy (except nonmelanomatous skin cancer) unless disease free for a minimum of 2 years; non-invasive conditions such as carcinoma in situ of the breast, oral cavity, or cervix are all permissible.

3. Known CNS lymphoma.

4. Prior or current treatment with certain medications. Talk to Study Contact for specifics.

5. Subject is at high risk for TLS.

6. Subject has malabsorption syndrome or other condition which may affect an enteral route of administration.

7. Subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.

8. Significant history of heart disease.

9. Subject has an active infection.

10. Known active Hepatitis B or Hepatitis C.

11. A serious uncontrolled medical disorder that in the opinion of the investigator would impair the ability of the subject to receive protocol therapy.