Neoplasms

Blood and Lymph Conditions

Immune System Diseases

All Conditions

Rare Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Venetoclax

Ibrutinib

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg

Each medication is taken daily. Treatment cycles are 28 days long.

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg

Each medication is taken daily. Treatment cycles are 28 days long.

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg

Each medication is taken daily. Treatment cycles are 28 days long.

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg

Each medication is taken daily. Treatment cycles are 28 days long.

The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion.

Chaitra Ujjani, MD

This is a phase I/II study in which patients will be enrolled in a standard 3+3 design. Once the maximum tolerated dose (MTD) is determined amongst patients with relapsed or refractory grade 1-3a follicular lymphoma, there will be a 17-patient phase II study.

In vitro studies of ibrutinib and venetoclax have noted significant cytotoxicity and synergy in mantle cell lymphoma and chronic lymphocytic leukemia cell lines.Data have demonstrated synergy between the two agents in various other B-cell Non-Hodgkin Lymphoma (NHL) cell lines. The investigators theorize that the combination of ibrutinib and venetoclax will provide dual, yet unique, targeted inhibition for patients with follicular lymphoma, resulting in both significant efficacy and less nonspecific toxicity.

Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma

The maximum tolerated dose of Ibrutinib and Venetoclax as determined by number of DLTs observed. • If 0/3 DLT is observed, dose escalation will continue to the next upper dose level. • If ≥ 2/3 DLTs are observed, then the dose finding procedure will be terminated.

• If 1/3 DLT is observed, then 3 additional patients will be enrolled in the same dose level. If no DLT is observed from the additional 3 patients, then dose escalation will continue to the next upper dose level. If any DLT is observed from the 3 additional patients, then the previously lower dose will be chosen as the MTD and the dose finding procedure will be terminated.

Number of participants on the recommended phase II dose level 2, with a partial or complete response, as determined by the revised Lugano Response Criteria for Non-Hodgkin Lymphoma,

Steady-state plasma concentrations of ibrutinib

Steady-state plasma concentrations of venetoclax

Toxicity (attribute and grade) will be summarized for each dose level for all patients who receive at least one dose of study treatment

AbbVie

Pharmacyclics LLC.

Hackensack Meridian Health

Georgetown University

Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.

Phase 1- Dose Level 0

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.

Phase 1 - Dose Level 1

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.

Phase 1 - Dose Level 2

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg Each medication is taken daily. Treatment cycles are 28 days long. Ibrutinib: Ibrutinib is dispensed as a capsule. Venetoclax: Venetoclax is dispensed as a tablet.

Phase 1- Dose Level 3

The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion. Phase II Dose = Dose level 2, Ibrutinib (560mg), Venetoclax (600mg).

Phase II- Dose Level 2

Ibrutinib (capsule) - 420mg Venetoclax (tablet) - 400mg

Each medication is taken daily. Treatment cycles are 28 days long.

Ibrutinib: Ibrutinib is dispensed as a capsule.

Venetoclax: Venetoclax is dispensed as a tablet.

Phase I - Dose Level 0

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 400mg

Each medication is taken daily. Treatment cycles are 28 days long.

Ibrutinib: Ibrutinib is dispensed as a capsule.

Venetoclax: Venetoclax is dispensed as a tablet.

Phase I - Dose Level 1

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 600mg

Each medication is taken daily. Treatment cycles are 28 days long.

Ibrutinib: Ibrutinib is dispensed as a capsule.

Venetoclax: Venetoclax is dispensed as a tablet.

Phase I - Dose Level 2

Ibrutinib (capsule) - 560mg Venetoclax (tablet) - 800mg

Each medication is taken daily. Treatment cycles are 28 days long.

Ibrutinib: Ibrutinib is dispensed as a capsule.

Venetoclax: Venetoclax is dispensed as a tablet.

Phase I - Dose Level 3

The Phase II dose will be the maximum tolerated dose as determined in the Phase I portion.

Ibrutinib: Ibrutinib is dispensed as a capsule.

Venetoclax: Venetoclax is dispensed as a tablet.

Phase II Dose

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

Dose Level 0: Ibrutinib (capsule) - 420mg, Venetoclax (tablet) - 400mg

Each medication is taken daily. Treatment cycles are 28 days long.

Recommended Phase 2 Dose (RP2D)

Recommended Phase II Dose Level = Dose level 2, Ibrutinib (560mg), Venetoclax (600mg).

Dose Level 2

Combined Phase I and Phase II participant on RP2D, Dose Level 2

Spots Global Cancer Trial Database for Ibrutinib and Venetoclax in Relapsed and Refractory Follicular Lymphoma

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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