Clinical trial · Interventional
Optimal Dose Finding Study ABT-199 and Ibrutinib in MCL
Multi-institution Phase I/Ib Study of Ibrutinib With ABT-199 in Relapsed/Refractory Mantle Cell Lymphoma
NCT02419560CI-TRIAL-00058692completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.98 |
| Recurrent Lymphoma, Mantle-Cell | Mantle Cell Lymphoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABT-199 and Ibrutinib Combination | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- ABT-199 and Ibrutinib Combination
- description
- Participants will take ABT-199 (dose 100-400 mg) and Ibrutinib (dose 280-560 mg).
- interventionNames
- Drug: ABT-199 and Ibrutinib Combination
Primary outcomes (1)
- measure
- Incidence of Dose Limiting Toxicities
- timeFrame
- 30 Days Following Start of Treatment
Secondary outcomes (5)
- measure
- Incidence and Severity of Adverse Events
- timeFrame
- Through 30 Days Following the Last Treatment
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDJayappa KD, Tran B, Gordon VL, Morris C, Saha S, Farrington CC, O'Connor CM, Zawacki KP, Isaac KM, Kester M, Bender TP, Williams ME, Portell CA, Weber MJ, Narla G. PP2A modulation overcomes multidrug resistance in chronic lymphocytic leukemia via mPTP-dependent apoptosis. J Clin Invest. 2023 Jul 3;133(13):e155938. doi: 10.1172/JCI155938. PMID 37166997
- DERIVEDPortell CA, Wages NA, Kahl BS, Budde LE, Chen RW, Cohen JB, Varhegyi NE, Petroni GR, Williams ME. Dose-finding study of ibrutinib and venetoclax in relapsed or refractory mantle cell lymphoma. Blood Adv. 2022 Mar 8;6(5):1490-1498. doi: 10.1182/bloodadvances.2021005357. PMID 34700344