Lymphoma

Open-Label Study of Parsaclisib, in Japanese Participants With Relapsed or Refractory Follicular Lymphoma (CITADEL-213)

Incyte Study ID:

INCB 50465-213

CT.gov ID:

NCT04434937
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Eudra ID:

N/A

EU CT Number:

N/A

Collaborator:

N/A

Study Contact Information:

+81 3-3507-5795 or [email protected]

Study Complete

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Results Available

Protocol

Available Languages: English

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Statistical Analysis Plan (SAP)

Available Languages: English

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Clinical Study Purpose

The purpose of this study is to assess the efficacy and safety of parsaclisib in Japanese participants with relapsed or refractory follicular lymphoma

Clinical Study Summary

MEDICAL CONDITION(S)

Lymphoma

PRODUCT

Drug: parsaclisib

COLLABORATORS

N/A

DATE

Sep 2020 - Oct 2023

TYPE

Interventional

PHASE

Phase 2

SEX

Female & Male

AGE

18+ years

ACCEPTS HEALTHY VOLUNTEERS

Clinical Study Locations

Name

NATIONAL HOSPITAL ORGANIZATION NAGOYA MEDICAL CENTER

NAGOYA, Japan, 460-0001

Name

Red Cross Nagoya Daini Hospital

Nagoya, Japan, 4668650

Name

NHO SHIKOKU CANCER CENTER

MATSUYAMA, Japan, 791-0280

Name

NIIGATA CANCER CENTER HOSPITAL

NIIGATA, Japan, 951-8566

Name

KOBE CITY MEDICAL CENTER GENERAL HOSPITAL

KOBE, Japan, 650-0047

Name

UNIVERSITY HOSPITAL KYOTO PREFECTURAL UNIVERSITY OF MEDICINE

KYOTO, Japan, 602-8566

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Key Inclusion and Exclusion Criteria

Inclusion Criteria

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

Exclusion Criteria

Known histological transformation from indolent NHL to DLBCL
History of central nervous system lymphoma (either primary or metastatic)

Requirements information

Inclusion Criteria

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.

Exclusion Criteria

Known histological transformation from indolent NHL to DLBCL
History of central nervous system lymphoma (either primary or metastatic)
Prior treatment with the following:
a. Selective PI3Kδ or pan-PI3K inhibitors (eg, idelalisib, copanlisib, duvelisib, etc).
b. Bruton's tyrosine kinase inhibitor (eg, ibrutinib).
Allogeneic SCT within the last 6 months, or autologous SCT within the last 3 months before the date of study treatment administration
Active graft-versus-host disease
Use of immunosuppressive therapy within 28 days of the date of study treatment administration
Concurrent anticancer therapy
Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, neurological, cerebral, or psychiatric disease
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.
Hepatitis B (HBV) or HCV infection
Current New York Heart Association Class II to IV congestive heart failure or uncontrolled arrhythmia

Protocol Summary

Incyte Study ID:

INCB 50465-213

Primary Purpose:

Treatment

Allocation:

N/A

Study Design:

Single Group Assignment

Masking:

None (Open Label)

Interventions:

Drug: parsaclisib

Enrollment:

Primary Outcome

Open