Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)
- Registration Number
- NCT04434937
- Lead Sponsor
- Incyte Biosciences Japan GK
- Brief Summary
The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 42
- Male or female Japanese participant who must be ≥ 18 years of age
- Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures
- Histologically confirmed, relapsed or refractory, FL Grade 1, 2, and 3a
- Ineligible for HSCT
- Must have been treated with at least 2 prior systemic therapies for FL
- Radiographically measurable lymphadenopathy or extranodal lymphoid malignancy (defined as the presence of ≥ 1 lesion that measures > 1.5 cm in the LD and ≥ 1.0 cm in the LPD, respectively) as assessed by CT or MRI
- Participants must be willing to undergo an incisional, excisional, or core needle lymph node or tissue biopsy or provide a lymph node or tissue biopsy collected after the completion of last therapy. An earlier archived lymph node or tissue biopsy is acceptable if hospitalization is required for biopsy (eg. no superficial lymph node) and SUVmax by FDG-PET is < 14
- ECOG performance status 0 to 2
- Life expectancy ≥ 12 weeks
- Adequate hematologic, hepatic, and renal functions ANC ≥ 1.0 × 109/L Hemoglobin ≥ 8.0 g/dL. Platelet count ≥ 50 × 109/L. Total bilirubin ≤ 1.5 × ULN. Participants with documented history of Gilbert's syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible.
ALT/AST ≤ 2.5× ULN or ≤ 5 × ULN in the presence of liver involvement. Calculated creatinine clearance ≥ 40 mL/min by the Cockcroft-Gault Equation or the estimated glomerular filtration rate ≥ 40 mL/min/1.73 m2 using the Modification of Diet in Renal Disease formula.
- Female participants agree to use medically acceptable contraceptive measures, should not be breastfeeding, and must have a negative pregnancy test before the start of study drug administration.
- Female participants of childbearing potential must understand and accept that pregnancy must be avoided during participation in the study.
- Male participants should avoid fathering children from screening through at least 93 days after the last dose of study treatment.
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Known histological transformation from indolent NHL to DLBCL
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History of central nervous system lymphoma (either primary or metastatic)
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Prior treatment with the following:
- Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc).
- Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
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Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months before the date of study treatment administration
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Active graft-versus-host disease
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Use of immunosuppressive therapy within 28 days of the date of study treatment administration
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Concurrent anticancer therapy
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Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease
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Current or previous other malignancy within 3 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in situ of the cervix, or other noninvasive or indolent malignancy without sponsor approval.
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Hepatitis B (HBV) or HCV infection
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Current New York Heart Association Class II to IV congestive heart failure or uncontrolled arrhythmia
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description parsaclisib parsaclisib parsaclisib will be taken orally QD with water without regard to food except on mornings of PK clinic visits
- Primary Outcome Measures
Name Time Method Objective Response Rate (ORR) up to approximately 3 years ORR was defined as the percentage of participants with a complete response (CR) or partial response (PR) as defined by revised response criteria for lymphoma, as determined by an Independent Review Committee (IRC). CR: target nodes/nodal masses regressed to ≤1.5 centimeters (cm) in the longest transverse diameter (LDi); no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate. PR: ≥50% decrease in sum of the product of the diameters (SPD) of up to 6 target measurable nodes and extranodal sites; absent/regressed nonmeasured lesions (but no increase); spleen regressed by \>50% in length beyond normal; and no new lesions.
- Secondary Outcome Measures
Name Time Method Complete Response Rate (CRR) up to approximately 3 years CRR was defined as the percentage of participants with a CR as defined by revised response criteria for lymphoma, as determined by an IRC. CR was defined as: target nodes/nodal masses regressed to ≤1.5 cm in the LDi; no nonmeasured lesions; regression to normal for organ enlargement; no new lesions; and normal bone marrow by morphology and negative immunohistochemistry if indeterminate.
Duration of Response (DOR) up to 20.0 months DOR was defined as the time from the first documented evidence of CR or PR until disease progression or death from any cause among participants who achieved an objective response, as determined by radiographic disease assessment provided by an IRC. Progressive disease was defined as ≥1 of the following: abnormal individual node/lesion meeting specific criteria; new/recurrent splenomegaly; new/clear progression of pre-existing nonmeasured lesions; regrowth of any previously resolved lesions; new node \>1.5 cm in any axis; new extranodal site \>1.0 cm in any axis; assessable disease of any size attributable to lymphoma; new/recurrent involvement of bone marrow.
Progression-free Survival (PFS) up to approximately 3 years 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. Progressive disease was defined as any new lesion or increase by ≥ 50% of previously involved sites from nadir.
Overall Survival up to approximately 3 years Overall survival was defined as the time from the date of the first dose of study treatment until death from any cause.
Best Percentage Change in Target Lesion Size From Baseline, as Determined by Independent Review Committee and the Investigator up to approximately 3 years Target lesion size was measured by the sum of the products of the diameters of all target lesion sizes. The best percent change from Baseline was defined as the largest decrease, or smallest increase if no decrease, from Baseline in target lesion sizes on/before new anti-lymphoma therapy during the study. Percentage change was calculated as (\[the post-Baseline value minus the Baseline value\] / the Baseline value) x 100.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) up to 1041 days An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could therefore have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last administration of study drug.
Number of Participants With Any Grade 3 or Higher TEAE up to 1041 days An adverse event was as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug and within 30 days of the last administration of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Trial Locations
- Locations (30)
Hyogo College of Medicine Hospital
🇯🇵Hyogo, Japan
Shizuoka Cancer Center
🇯🇵Shizuoka, Japan
Nho Shikoku Cancer Center
🇯🇵Matsuyama, Japan
Tenri Hospital
🇯🇵Nara, Japan
Kobe City Medical Center General Hospital
🇯🇵Kobe, Japan
Nho Hokkaido Cancer Center
🇯🇵Sapporo, Japan
Hokuyukai Sapporo Hokuyu Hospital
🇯🇵Hokkaido, Japan
Tokai University Hospital
🇯🇵Isehara, Japan
National Hospital Organization Nagoya Medical Center
🇯🇵Nagoya, Japan
Fukushima Medical University Hospital
🇯🇵Fukushima, Japan
Ja-Aichi Anjo Kosei Hospital
🇯🇵Anjo, Japan
University of Fukui Hospital
🇯🇵Fukui, Japan
Niigata Cancer Center Hospital
🇯🇵Niigata, Japan
Jiaikai Imamura General Hospital
🇯🇵Kagoshima, Japan
Jcho Kyushu Hospital
🇯🇵Fukuoka, Japan
Nho Matsumoto Medical Center
🇯🇵Matsumoto, Japan
Nho Mito Medical Center
🇯🇵Ibaraki, Japan
Nagano Red Cross Hospital
🇯🇵Nagano, Japan
Japanese Red Cross Nagoya Daini Hospital
🇯🇵Nagoya, Japan
Miyagi Cancer Center
🇯🇵Natori, Japan
Red Cross Nagoya Daini Hospital
🇯🇵Nagoya, Japan
Okayama University Hospital
🇯🇵Okayama, Japan
Yokohama Municipal Citizens Hospital
🇯🇵Yokohama, Japan
Yokohama City University Medical Center
🇯🇵Yokohama, Japan
National Hospital Organization Kyushu Cancer Center
🇯🇵Fukuoka, Japan
Kansai Medical University Hospital
🇯🇵Hirakata, Japan
University Hospital Kyoto Prefectural University of Medicine
🇯🇵Kyoto, Japan
Tohoku University Hospital
🇯🇵Sendai-shi, Japan
Ogaki Municipal Hospital
🇯🇵Ogaki, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Japan