A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma

Browse trials for

• Lymphoma 5,578
• Lymphoma, Follicular 931

Keywords

• Follicular lymphoma
• non-Hodgkin lymphoma (NHL)
• phosphatidylinositol 3-kinase (PI3K) δ inhibitor

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 126 is above the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Lead sponsor

Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.

Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.

Study arms

• Experimental
  Treatment A: Parsaclisib 20 mg QD for 8 Weeks Followed by 20 mg QW

  Participants received parsaclisib 20 mg once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to approximately 52 weeks.

  Drug: Parsaclisib

• Experimental
  Treatment B: Parsaclisib 20 mg QD for 8 Weeks Followed by 2.5 mg QD

  Participants received parsaclisib 20 mg QD for 8 weeks followed by 2.5 mg QD for up to approximately 52 weeks.

  Drug: Parsaclisib

Interventions

• DrugParsaclisib

  Parsaclisib tablets administered orally with water and without regard to food

  Also known as: INCB050465

Primary outcomes

1. Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria

   ORR=percentage of participants with complete response(CR) or partial response(PR) per revised response criteria for lymphomas,determined by independent review committee(IRC).Criteria for CR:1.Target nodes/nodal masses of lymph nodes,extralymphatic sites regressed to≤1.5cm in longest dimension transverse diameter of lesion(LDi);2.Absence of non-measured lesion;3.Organ enlargement regressed to normal;4.No new lesions;5.Normal bone marrow morphology;if indeterminate,immunohistochemistry negative.Criteria for PR:1.Lymph nodes,extralymphatic sites- ≥50%decrease in sum of product of perpendicular diameters for multiple lesions(SPD)of up to 6 target measurable nodes,extranodal sites;if lesion is too small to measure on computed tomography(CT),assign5mm×5mm as default;if no longer visible,0×0mm.Node\>5mm×5mm but smaller than normal,use actual measurement.2.Absent/regressed non-measured lesions,no increase.3.Organ enlargement-Spleen regressed by\>50%in length beyond normal.4.No new lesions.

   Time frame: Up to approximately 148 weeks

Secondary outcomes

1. Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria

   CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphomas as determined by an IRC. The criteria for CR included: 1. Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3. Organ enlargement regressed to normal; 4. No new lesions; 5. Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative.

   Time frame: Up to 1193 days

2. Duration of Response (DOR)

   DOR=time from first documented evidence of CR or PR until disease progression or death from any cause among participants who achieve an objective response as determined by IRC. Criteria for CR: 1.Target nodes/nodal masses of lymph nodes and extralymphatic sites must regress to ≤ 1.5 cm in LDi; 2. Absence of non-measured lesion; 3.Organ enlargement regressed to normal; 4.No new lesions; 5.Bone marrow must be normal by morphology; if indeterminate, immunohistochemistry negative. The criteria for PR included: 1.Lymph nodes and extralymphatic sites- a. ≥50% decrease in SPD of up to 6 target measurable nodes and extranodal sites; b. when a lesion is too small to measure on CT, assign 5 mm×5 mm as the default; c.when no longer visible, 0×0 mm. For a node \>5 mm×5 mm but smaller than normal, use actual measurement. 2.Non-measured lesions- Absent/regressed, but no increase. 3. Organ enlargement-Spleen must have regressed by \>50% in length beyond normal. 4.No new lesions.

   Time frame: Up to 1193 days

3. Progression-free Survival (PFS) With Parsaclisib

   PFS was defined as the time from the date of the first dose of study treatment until the earliest date of disease progression, as determined by radiographic disease assessment provided by an IRC, or death from any cause.

   Time frame: Up to 1193 days

4. Overall Survival (OS) With Parsaclisib

   OS was defined as the time from the date of the first dose of study treatment until death from any cause.

   Time frame: Up to 1193 days

5. Best Percent Change From Baseline in Target Lesion Size

   Target lesion size is measured by the sum of the product of diameters of all target lesion sizes and is determined by the IRC. The best percent change from Baseline is defined as the largest decrease, or smallest increase (if no decrease available), from Baseline in target lesion sizes on/before new (next-line) anti-lymphoma therapy during the study. Baseline is the last non-missing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.

   Time frame: Up to 1193 days

6. Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

   An adverse event (AE) is defined as any untoward medical occurrence associated with use of a drug in humans, whether or not considered drug related, that occurs after a participant provides informed consent. TEAE is any AE either reported for first time or worsening of a pre-existing event after first dose of study drug and within 30 days of last administration of study drug regardless of starting new anti-lymphoma therapy. SAE is any untoward medical occurrence that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, leads to a congenital anomaly/birth defect or is considered to be an important medical event that may not result in death, be immediately life-threatening, or require hospitalization but may be considered serious when, based on appropriate medical judgment, the event may jeopardize the participant or may require medical or surgical intervention.

   Time frame: up to approximately 1992 days

Baseline characteristics

Study documents

• Study protocol · Dec 23, 2019
• Statistical analysis plan · Jan 28, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency

Supporting information: Study protocol, Sap