CompletedPhase 1

Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL

United States37 participantsStarted 2015-04

Plain-language 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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Diagnosed with Mantle Cell Lymphoma and has had at least one chemotherapy.
✓. Subjects must have measurable or evaluable disease.
✓. ECOG Performance Status of 0-2.
✓. Must be referred for treatment with ibrutinib.
✓. Must have adequate organ function.

Exclusion criteria

✕. Subject is pregnant.
✕. 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.
✕. Known CNS lymphoma.
✕. Prior or current treatment with certain medications. Talk to Study Contact for specifics.
✕. Subject is at high risk for TLS.
✕. Subject has malabsorption syndrome or other condition which may affect an enteral route of administration.
✕. Subject has known contraindication or allergy to both xanthine oxidase inhibitors and rasburicase.
✕. Significant history of heart disease.

What they're measuring

Incidence of Dose Limiting Toxicities

Timeframe: 30 Days Following Start of Treatment

Trial details

NCT IDNCT02419560

SponsorCraig Portell, MD

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-05

View on ClinicalTrials.gov More Lymphoma, Mantle-Cell trials