A Phase II Study of Duvelisib Maintenance After First-Line Therapy for Peripheral T-Cell Lymphoma
City of Hope Medical Center
Summary
This phase II trial tests how well duvelisib works as treatment that is given to help keep cancer from coming back after it has disappeared following the initial therapy (maintenance) for patients with peripheral T-cell lymphomas. Duvelisib is in a class of medications called kinase inhibitors. It works by blocking the signals that cause cancer cells to multiply. This helps to stop the spread of cancer cells.
Description
PRIMARY OBJECTIVE: I. Determine the efficacy of duvelisib maintenance therapy in peripheral T-cell lymphoma (PTCL) patients who have achieved a complete response (CR) following first-line treatment and are either ineligible for or decline consolidative autologous stem cell transplantation (ASCT). SECONDARY OBJECTIVE: I. Determine the tolerability and preliminary survival outcomes of duvelisib maintenance therapy. EXPLORATORY OBJECTIVE: I. Examine the association between biomarkers (e.g., minimal residual disease \[MRD\]) and clinical outcomes (overall response rate \[ORR\], progression fr…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative. * Assent, when appropriate, will be obtained per institutional guidelines * Age: ≥ 18 years * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * Histologically confirmed nodal T-follicular helper (TFH) cell lymphomas or PTCL-not otherwise specified (NOS). Nodal TFH cell lymphomas encompass three subtypes: * Angioimmunoblastic T-cell lymphoma (AITL)(World Health Organization 4th edition revised \[WHO4R\])/follicular helper T-cell lymphoma (TFH lymphoma), angioimmunoblastic type (In…
Interventions
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration
- ProcedureBone Marrow Biopsy
Undergo bone marrow biopsy
- ProcedureComputed Tomography
Undergo CT scan
- DrugDuvelisib
Given PO
- ProcedurePositron Emission Tomography
Undergo PET scan
- OtherSurvey Administration
Location
- City of Hope Medical CenterDuarte, California