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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04334174
Other study ID # IIT-2019-BRENTICON-T
Secondary ID
Status Withdrawn
Phase Phase 2
First received
Last updated
Start date May 29, 2020
Est. completion date February 1, 2023

Study information

Verified date February 2023
Source University of Kansas Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

For participants with CD30 positive Mature T-cell lymphomas who have received brentuximab vedotin, cyclophosphamide, doxorubicin, and prednisone (A-CHP) as induction (4 to 6 cycles) and achieved complete response (CR) or chemo-sensitive partial response (PR) and deemed suitable for autologous stem cell transplant (ASCT) as consolidation, the investigators propose to add brentuximab vedotin after ASCT. There is currently no standard of care treatment to prevent relapse after upfront treatment or ASCT for CD30-positive peripheral T-cell lymphoma's (PTCL)s. An agent that could improve outcomes in this population would be a major contribution to the field and is likely to be practice changing. Therefore, in addition to studying the anti-lymphoma activity of A-CHP as induction therapy, for participants who respond to induction the investigators propose to add brentuximab vedotin consolidation after ASCT in participants treated with consolidative upfront ASCT.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 1, 2023
Est. primary completion date December 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - A-CHP for 6 cycles. First cycle may be cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP)- based if already planned and then 5 cycles of A-CHP. - Performance status of 0-2. - Participants with CD30 positive mature T- cell lymphomas who have received A-CHP as induction and achieved complete response (CR) or chemo- sensitive partial response (PR) and deemed suitable for ASCT as consolidation. - Eligible disease types: - Anaplastic lymphoma kinase (ALK)- negative systemic Anaplastic large-cell lymphoma (sALCL) - Peripheral T-cell lymphoma- not otherwise specified (PTCL-NOS) - Angioimmunoblastic T-cell lymphoma (AITL) - Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1) - Enteropathy-associated T-cell lymphoma (EATL) - Hepatosplenic T-cell lymphoma (HSTCL) - Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography (PET) and measurable disease by Computed tomography (CT), as assessed by the site radiologist. - Adequate organ function. Exclusion Criteria: - Enrolled in any other treatment clinical trial. - Is breastfeeding. - Active severe or medically significant or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment. - Has human immunodeficiency virus (HIV) infection, hepatitis B surface antigen-positive status, or known or suspected active hepatitis C infection. - Left ventricular ejection fraction (LVEF) less than 45% or symptomatic cardiac disease, or myocardial infarction within the past 6 months. - Previous treatment with complete cumulative doses of doxorubicin or other anthracyclines. - Baseline, moderate, peripheral neuropathy or patients with the demyelinating form of Charcot-Marie-Tooth syndrome. - Post auto or allo stem cell transplant (SCT). - Cerebral/meningeal disease related to the underlying malignancy. - History of progressive multifocal leukoencephalopathy (PML). - Current diagnosis of any of the following: - Primary cutaneous CD30-positive T-cell lymphoproliferative disorders and lymphomas. Cutaneous ALCL with tumor spread outside of the skin and to lymph nodes away from the primary site are eligible.

Study Design


Intervention

Drug:
Brentuximab Vedotin
Brentuximab Vedotin will be dosed at 1.8 milligram (mg) per (/) kilogram (Kg) of participants body weight will be infused intravenously every three weeks for up to ten infusions.

Locations

Country Name City State
United States The University of Kansas Cancer Center, Westwood Campus Kansas City Kansas

Sponsors (2)

Lead Sponsor Collaborator
University of Kansas Medical Center Seagen Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of participants who experience safety related issues caused by study treatment: CTCAEv5 Using the Common Terminology Criteria for Adverse Events version 5 (CTCAEv5) to evaluate participants reaction to treatment. Up to three years
Secondary Progression Free Survival Comparing statistical survival rates with survival rates of study participants. From date of randomization until the date of first documented progression or to death due to any cause, whichever comes first, up to 3 years.
Secondary The number of adverse events or laboratory abnormalities Monitoring the number of adverse events or laboratory abnormalities using the CTCAEv5 as reference. 30 days
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