Ceritinib With Brentuximab Vedotin in Treating Patients With ALK-Positive Anaplastic Large Cell Lymphoma
|ClinicalTrials.gov Identifier: NCT02729961|
Recruitment Status : Withdrawn (Administrative closure)
First Posted : April 6, 2016
Last Update Posted : October 10, 2019
|Condition or disease||Intervention/treatment||Phase|
|Anaplastic Large Cell Lymphoma, ALK-Positive CD30-Positive Neoplastic Cells Present Systemic Anaplastic Large Cell Lymphoma||Drug: Brentuximab Vedotin Drug: Ceritinib Other: Laboratory Biomarker Analysis Other: Pharmacological Study||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I/II Open-Label Dose-Finding Study of Ceritinib Combined With Brentuximab Vedotin for Front-Line Treatment of ALK-Positive Anaplastic Large Cell Lymphoma|
|Actual Study Start Date :||January 3, 2018|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 1, 2023|
Experimental: Treatment (brentuximab vedotin, ceritinib)
Patients receive brentuximab vedotin IV over 30 minutes on day 1. Patients also receive ceritinib PO QD on days 8-21 of course 1 and on days 1-21 for all subsequent courses. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Drug: Brentuximab Vedotin
Other: Laboratory Biomarker Analysis
Other: Pharmacological Study
- Complete remission rate defined as the proportion of patients with CR according to the revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to 3 years ]
- Maximum tolerated dose (MTD) of ceritinib and brentuximab vedotin based on incidence of dose limiting toxicity (DLT) assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 [ Time Frame: Up to 6 weeks ]
- Objective response rate defined as the proportion of patients with complete response (CR) or partial response (PR) according to the revised Response Criteria for Malignant Lymphoma [ Time Frame: Up to 3 years ]Assessed using clinical assessment and computed tomography (CT)/positron emission tomography (PET) scans.
- Incidence of adverse events as assessed by NCI CTCAE version 4.03 [ Time Frame: Up to 30 days ]
- Laboratory abnormalities as assessed by NCI CTCAE version 4.03 [ Time Frame: Up to 3 years ]
- Overall survival (OS) [ Time Frame: From start of study treatment to date of death due to any cause, assessed up to 3 years ]
- Progression-free survival (PFS) [ Time Frame: From start of treatment to first documentation of objective tumor progression or to death due to any cause, whichever comes first, assessed up to 3 years ]Evaluate tumor lesion size in the determination of PFS by using Revised Response Criteria for Malignant Lymphoma (modified Cheson, 2011).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02729961
|United States, Washington|
|Fred Hutch/University of Washington Cancer Consortium|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Andrei Shustov||Fred Hutch/University of Washington Cancer Consortium|