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ABT-199 and Ibrutinib Combination

Phase 1

Lymphoma, Mantle-Cell | Small molecule | Oncology |AbbVie Inc.|Last Updated: May 24, 2022

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

ABT-199 and Ibrutinib Combination · 1 trial · 2 indications

Phase 1 1
NCT02419560Optimal Dose Finding Study ABT-199 and Ibrutinib in MCLLymphoma, Mantle-Cell
COMPLETED37 Analytics
PHASE1COMPLETED
Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL
Lymphoma, Mantle-Cell
NCT0241956037
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Study Endpoints

Primary Endpoints

Incidence of Dose Limiting Toxicities
30 Days Following Start of Treatment

Secondary Endpoints

Incidence and Severity of Adverse Events
Through 30 Days Following the Last Treatment
Overall Response Rate
Every Year Until Death; an Average of 2 Years
Complete Response Rate
Every Year Until Death; an Average of 2 Years
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
ABT-199 and Ibrutinib CombinationEXPERIMENTALParticipants will take ABT-199 (dose 100-400 mg) and Ibrutinib (dose 280-560 mg).

Interventions

NameTypeDescription
ABT-199 and Ibrutinib CombinationDRUGBoth are administered orally once daily.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

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...

Countries:United States
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Frequently asked questions about ABT-199 and Ibrutinib Combination

What is ABT-199 used for?

ABT-199 is an investigational small molecule being studied for use in several blood cancers and autoimmune conditions, including chronic lymphocytic leukemia, non-Hodgkin lymphoma, small lymphocytic lymphoma, mantle-cell lymphoma, acute myelogenous leukemia, and lupus erythematosus. It is being developed by AbbVie Inc. and is currently in Phase 2 clinical development.

Who makes ABT-199?

ABT-199 is being developed by AbbVie Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker ABBV. The drug is an investigational small molecule in Phase 2 clinical development for oncology and autoimmune indications.

What phase is ABT-199 in?

ABT-199 is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA. The drug is being studied for multiple conditions, including chronic lymphocytic leukemia, non-Hodgkin lymphoma, and lupus erythematosus.

What clinical trials is ABT-199 in?

ABT-199 has completed three Phase 1 clinical trials. NCT01328626 evaluated safety and pharmacokinetics in 222 patients with relapsed or refractory chronic lymphocytic leukemia and non-Hodgkin lymphoma. NCT01682616 studied ABT-199 in combination with rituximab in 49 patients with relapsed chronic lymphocytic leukemia and small lymphocytic lymphoma. NCT01686555 evaluated the drug in 97 female patients with systemic lupus erythematosus.

Is ABT-199 being studied in mantle-cell lymphoma?

Yes, ABT-199 is being studied in mantle-cell lymphoma. A completed Phase 1 trial, NCT02419560, evaluated optimal dosing of ABT-199 in combination with ibrutinib in 37 patients with recurrent mantle-cell lymphoma. The trial was conducted in the United States.

What is the development status of ABT-199 in lupus erythematosus?

ABT-199 has been studied in lupus erythematosus. A completed Phase 1 trial, NCT01686555, evaluated the safety, tolerability, and pharmacokinetics of ABT-199 in 97 female patients with systemic lupus erythematosus. The trial was conducted in the United States, Germany, Mexico, and Puerto Rico.