A Study of INCB050465 in Relapsed or Refractory Follicular Lymphoma (CITADEL-203)
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| ClinicalTrials.gov Identifier: NCT03126019 |
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Recruitment Status :
Active, not recruiting
First Posted : April 24, 2017
Results First Posted : February 10, 2022
Last Update Posted : January 5, 2024
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Sponsor:
Incyte Corporation
Information provided by (Responsible Party):
Incyte Corporation
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Brief Summary:
The purpose of this study is to assess the objective response rate of parsaclisib treatment in participants with relapsed or refractory follicular lymphoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lymphoma | Drug: Parsaclisib | Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 126 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Sequential Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2, Multicenter, Open-Label Study of INCB050465, a PI3Kδ Inhibitor in Relapsed or Refractory Follicular Lymphoma (CITADEL-203) |
| Actual Study Start Date : | March 14, 2018 |
| Actual Primary Completion Date : | February 26, 2021 |
| Estimated Study Completion Date : | July 31, 2024 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Parsaclisib
Parsaclisib tablets administered orally with water and without regard to food
Other Name: INCB050465 |
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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.
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Drug: Parsaclisib
Parsaclisib tablets administered orally with water and without regard to food
Other Name: INCB050465 |
Primary Outcome Measures :
- Objective Response Rate With Parsaclisib Based on Lugano Classification Response Criteria [ Time Frame: Up to approximately 148 weeks ]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.
Secondary Outcome Measures :
- Complete Response Rate With Parsaclisib Based on Lugano Classification Response Criteria [ Time Frame: Up to approximately 148 weeks ]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.
- Duration of Response (DOR) [ Time Frame: Up to approximately 148 weeks ]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.
- Progression-free Survival (PFS) With Parsaclisib [ Time Frame: Up to approximately 148 weeks ]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.
- Overall Survival (OS) With Parsaclisib [ Time Frame: Up to approximately 148 weeks ]OS was defined as the time from the date of the first dose of study treatment until death from any cause.
- Best Percent Change From Baseline in Target Lesion Size [ Time Frame: Up to approximately 148 weeks ]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.
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: From first dose of study drug up to approximately 148 weeks ]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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03126019
Locations
Show 83 study locations
Sponsors and Collaborators
Incyte Corporation
Investigators
| Study Director: | Fred Zheng, MD, PhD | Incyte Corporation |
Study Documents (Full-Text)
Documents provided by Incyte Corporation:
Documents provided by Incyte Corporation:
Study Protocol [PDF] December 23, 2019
Statistical Analysis Plan [PDF] January 28, 2021
| Responsible Party: | Incyte Corporation |
| ClinicalTrials.gov Identifier: | NCT03126019 |
| Other Study ID Numbers: |
INCB 50465-203 (CITADEL-203) Parsaclisib ( Other Identifier: Incyte Corporation ) 2017-001624-22 ( EudraCT Number ) |
| First Posted: | April 24, 2017 Key Record Dates |
| Results First Posted: | February 10, 2022 |
| Last Update Posted: | January 5, 2024 |
| Last Verified: | January 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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 Materials: |
Study Protocol Statistical Analysis Plan (SAP) |
| Time Frame: | Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications. |
| Access Criteria: | Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement |
| URL: | https://www.incyte.com/our-company/compliance-and-transparency |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Incyte Corporation:
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Follicular lymphoma non-Hodgkin lymphoma (NHL) phosphatidylinositol 3-kinase (PI3K) δ inhibitor |
Additional relevant MeSH terms:
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Lymphoma Lymphoma, Follicular Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders |
Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Lymphoma, Non-Hodgkin |