A Study of INCB050465 in Relapsed or Refractory Mantle Cell Lymphoma Previously Treated With or Without a Bruton's Tyrosine Kinase (BTK) Inhibitor

Browse trials for

• Lymphoma 5,577
• Lymphoma, Mantle-Cell 783

Keywords

• Mantle cell lymphoma
• non-Hodgkin lymphoma
• Bruton's tyrosine kinase (BTK)
• phosphatidylinositol 3-kinase (PI3K)

Lymphoma

5,577 studies on the registry are indexed under Lymphoma; 824 are open to participants now.

This study's enrollment of 162 is above the median of 40 across 4,507 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
  Cohort 1: Treatment A (Exposed to Ibrutinib)

  Participants received parsaclisib 20 mg tablets, orally, once daily (QD) for 8 weeks followed by 20 mg once weekly (QW) for up to 52 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

  Drug: Parsaclisib

• Experimental
  Cohort 1: Treatment B (Exposed to Ibrutinib)

  Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to 116 weeks. Participants who were exposed to ibrutinib before enrollment were included in this group.

  Drug: Parsaclisib

• Experimental
  Cohort 2: Treatment A (Bruton's Tyrosine Kinase Inhibitor Naïve)

  Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 20 mg QW for up to approximately 145 weeks. Participants who had not received a BTK inhibitor previously were included in this group.

  Drug: Parsaclisib

• Experimental
  Cohort 2: Treatment B (Bruton's Tyrosine Kinase Inhibitor Naïve)

  Participants received parsaclisib 20 mg tablets, orally, QD for 8 weeks followed by 2.5 mg QD for up to approximately 136 weeks. Participants who had not received a BTK inhibitor previously were included in this group.

  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 (ORR)

   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 1016 days

Secondary outcomes

1. 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 1016 days

2. Complete Response Rate (CRR)

   CRR is defined as the percentage of participants with a CR as defined by 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 1016 days

3. Progression-Free Survival (PFS)

   PFS is 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 1016 days

4. Overall Survival (OS)

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

   Time frame: Up to 2017 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 nonmissing measurement obtained before the first administration of study drug. A negative percent change from Baseline indicates improvement.

   Time frame: Up to 1016 days

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

   An adverse event (AE) is 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. A TEAE is any AE either reported for the first time or worsening of a pre-existing event after first dose of study drug and within 30 days of the last administration of study drug regardless of starting new anti-lymphoma therapy. A 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: From first dose of study drug up to 2045 days

Baseline characteristics

Study documents

• Study protocol · Jan 30, 2020
• 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 — Individual participant data (IPD) will be made available to interested researchers after the end of study, a thorough analysis, and the publication of the data in the clinical study report (CSR). As required, results of the data will be posted to ClinicalTrials.gov. Upon request, individual investigators may obtain IPD from the sponsor. The format for data delivery will be determined between sponsor and investigator.

Supporting information: Study protocol, Sap