Status:
WITHDRAWN
Study of Brentuximab Vedotin as Therapy After Autologous Stem Cell Transplant in Cluster of Differentiation Antigen 30 (CD30) Positive Peripheral TCell Lymphomas
Lead Sponsor:
University of Kansas Medical Center
Collaborating Sponsors:
Seagen Inc.
Conditions:
T Cell Lymphoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 compl...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04334174
Start Date
May 29 2020
End Date
February 1 2023
Last Update
February 3 2023
Active Locations (1)
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1
The University of Kansas Cancer Center, Westwood Campus
Kansas City, Kansas, United States, 66205