Non-Hodgkin Lymphoma or Chronic Lymphocytic Leukemia MedDRA version: 20.0 Level: PT Classification code 10076596 Term: Marginal zone lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.0 Level: LLT Classification code 10012883 Term: Diffuse lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 21.1 Level: PT Classification code 10026801 Term: Mantle
Conditions
Interventions
Product Name: parsaclisib 1 mg compressa
Product Code: [INCB050465 1 mg compressa]
Pharmaceutical Form: Tablet
INN or Proposed INN: PARSACLISIB
CAS Number: 1426698-88-5
Current Sponsor code: INCB05046
Sponsors
INCYTE CORPORATION
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged >= 18 years at the time of consent. 2. Ability to comprehend and willingness to sign a written ICF and comply with all study visits and procedures. 3. Histologically confirmed R/R B-cell malignancy of the following types: a. Cohort 1: DLBCL not otherwise specified, T-cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr virus–positive DLBCL of the elderly, Grade 3b FL, high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements (double-hit or triple-hit lymphoma), histological transformation from an earlier diagnosis of low-grade lymphoma (such as FL, MZL, CLL) into DLBCL b. Cohort 2: MCL with documentation of either overexpression of cyclin D1 or t(11;14) c. Cohort 3: FL Grade 1, 2, and 3a d. Cohort 4: MZL, including extranodal, nodal, and splenic subtypes e. Cohort 5: CLL or SLL 4. Received at least 2 prior systemic treatment regimens as follows: a. Cohorts 1 and 2 (DLBCL, MCL): Must have been previously treated with at least 1 prior chemoimmunotherapy regimen that included an anti-CD20 antibody. This includes treatments such as chemotherapy plus rituximab or obinutuzumab, with or without rituximab or obinutuzumab maintenance. Note: At least 6 doses of anti-CD20 chemoimmunotherapy must have been given in prior therapy. b. Cohorts 3 and 4 (FL, MZL): Must have been previously treated with at least 1 prior chemoimmunotherapy or immunotherapy regimen that included an anti-CD20 antibody. This includes treatments such as rituximab or obinutuzumab monotherapy or chemotherapy plus rituximab or obinutuzumab, with or without rituximab or obinutuzumab maintenance. Note: At least 6 doses of anti-CD20 immunotherapy must have been given in prior therapy. c. Cohort 5 (CLL/SLL): Must have been previously treated with at least 1 prior systemic therapy including a BTK inhibitor regimen or chemoimmunotherapy regimen that included an anti-CD20 antibody. 5. Relapsed, progressive, or refractory NHL or CLL: a. Relapsed: PD after response of CR to prior therapy. b. Progressive: PD after response of PR or stable disease to prior therapy. c. Refractory: achieved less than PR to the last prior therapy, or achieved a CR or PR that lasted =65 years) yes F.1.3.1 Number of subjects for this age range 70
Exclusion criteria
Exclusion criteria: 1. Any other histological type of lymphoma according to the WHO 2016 classification of lymphoid neoplasms, for example, primary mediastinal B-cell lymphoma, Burkitt lymphoma, B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma (gray zone lymphoma); primary effusion lymphoma; primary cutaneous DLBCL, leg type; intravascular B cell lymphoma. 2. History of or evidence of CNS lymphoma (primary and secondary). 3.Any anticancer and/or investigational therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization) within 30 days or 5 half-lives (whichever is greater) prior to the first dose of study treatment (C1D1). 4. Inadequate recovery (> Grade 1) from toxicity and/or complications from a major surgery before C1D1.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: * Dose confirmation period (Phase 1b): To determine the safety, tolerability, and DLTs of combination therapy with tafasitamab + parsaclisib in participants with R/R NHL or CLL who have been previously treated with at least 2 prior lines of systemic anti-lymphoma therapy. * Dose expansion period (Phase 2a): To assess the preliminary efficacy of combination therapy with tafasitamab + parsaclisib in participants with R/R NHL or CLL who have been previously treated with at least 2 prior lines of systemic anti-lymphoma therapy.;Secondary Objective: To estimate the PK of tafasitamab when given as combination therapy with parsaclisib;Primary end point(s): * Dose confirmation period (Phase 1b): Incidence and severity of TEAEs and incidence of DLTs. * Dose expansion period (Phase 2a): ORR, defined as the percentage of participants having best response of CR/CMR or PR/PMR per investigator assessment.;Timepoint(s) of evaluation of this end point: * Dose confirmation period (Phase 1b): after 1 cycle (28 days) * Dose expansion period (Phase 2a): ORR will be analyzed when all subjects in the respective cohort have received at least 1 post-baseline disease assessment or have progressed, withdrawn from the study, or died | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PK parameters of tafasitamab when given in combination with parsaclisib. Ctrough (ie, predose), Cmax, tmax, Cmin, and AUCt will be summarized by descriptive statistics.;Timepoint(s) of evaluation of this end point: throughout the study | — |
Countries
France, Germany, Italy, Spain, United States
Contacts
Public ContactClinical Trial Information
Incyte Corporation
Outcome results
None listed