A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma
Completed · Phase 2
Conditions studied: Lymphoma
In brief
The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.
Key facts
- Study ID
- NCT03126019
- Run by
- Incyte Corporation
- People needed
- 126
- Starts
- 2018-03-14
- Expected to finish
- 2024-06-07
- Last updated by the study team
- 2025-03-14
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Aged 18 years or older.
- Histologically confirmed, relapsed or refractory, follicular B-cell non-Hodgkin lymphoma (NHL) (follicular lymphoma) Grade 1, 2, and 3a.
- Ineligible for hematopoietic stem cell transplant.
- Must have been treated with at least 2 prior systemic therapies.
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the longest dimension and ≥ 1.0 cm in the longest perpendicular dimension as assessed by computed tomography or magnetic resonance imaging.
- Must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy from the most recent available archival tissue.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
You may not qualify if…
- Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
- History of central nervous system lymphoma (either primary or metastatic).
- Prior treatment with idelalisib, other selective phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitors, or a pan-PI3K inhibitor.
- Prior treatment with a Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
- Allogeneic stem cell transplant within the last 6 months, or autologous stem cell transplant within the last 3 months before the date of study treatment administration.
- Active graft-versus-host disease.
- Participants positive for hepatitis B surface antigen or hepatitis B core antibody will be eligible if they are negative for hepatitis B virus-deoxyribonucleic acid (HBV-DNA). Participants positive for anti-hepatitis C virus (HCV) antibody will be eligible if they are negative for HCV-ribonucleic acid (RNA).
Where it is running
- Beverly Hills Cancer Center — Beverly Hills, California, United States
- Synergy Hematology and Oncology Medical Associates — Los Angeles, California, United States
- St. Joseph Heritage Healthcare — Santa Rosa, California, United States
- American Institute of Research Corporate Office — Whittier, California, United States
- Cancer Center of Central Connecticut — Southington, Connecticut, United States
- Florida Cancer Specialists & Research Institute — Fort Myers, Florida, United States
- Asclepes Research Centers — Spring Hill, Florida, United States
- Clinical Trials of Swla Llc — Lake Charles, Louisiana, United States
- Saint Agnes Hospital — Baltimore, Maryland, United States
- Barbara Ann Karmanos Cancer Hospital — Detroit, Michigan, United States
- Hattiesburg Clinic Hematology — Hattiesburg, Mississippi, United States
- Saint Luke'S Hospital — Kansas City, Missouri, United States
- Sarah Cannon Research Institute — Kansas City, Missouri, United States
- Clinical Research Alliance, Inc. — New Hyde Park, New York, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Gabrail Cancer Center — Canton, Ohio, United States
- University of Pennsylvania Health System — Philadelphia, Pennsylvania, United States
- Charleston Hematology Oncology Associates Pa — Charleston, South Carolina, United States
- Tennessee Oncology — Nashville, Tennessee, United States
- Renovatio Clinical Consultants Llc — Spring, Texas, United States
- University of Washington — Seattle, Washington, United States
- Western Health — St Albans, Victoria, Australia
- Border Medical Oncology — Wodonga, Victoria, Australia
- St Vincent'S Hospital Sydney — Darlinghurst, Australia
- Arizona Oncology Associates - Biltmore Cancer Center — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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