The purpose of this single-arm, open-label, Phase 1b/2a, multicenter basket study is to evaluate whether tafasitamab and parsaclisib can be safely combined at the recommended Phase 2 dose (RP2D) and dosing regimen that was established for each of the 2 compounds as a treatment option for adult participants with R/R B-cell malignancies.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
54
tafasitamab will be administered at a protocol defined dose once a week for cycles 1-3 and every other week from cycle 4 until progression.
parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE )
An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study treatment. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug.
Time frame: up to 1092 days
Number of Participants With Any ≥Grade 3 TEAE
An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until 90 days after the last dose of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. 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.
Time frame: up to 1092 days
Number of Participants With Dose-limiting Toxicities (DLTs)
A DLT was defined as the occurrence of any protocol-defined toxicity up to and including Day 28 (Cycle 1/Day 28), except those with a clear alternative explanation.
Time frame: up to 28 days
Objective Response Rate Based on Investigator Assessment: Percentage of Participants With CR/CMR or PR/PMR According to Lugano Criteria for NHL and International Working Group for Chronic Lymphocytic Leukemia (iwCLL) Criteria for CLL
Lugano complete response/complete metabolic response (CR/CMR): target nodes/masses of lymph nodes/extralymphatic sites (LNs/ELSs) regressed to ≤1.5 cm; no non-measured lesions; organ enlargement regressed to normal; no new lesions (NNLs); normal bone marrow. Lugano partial response/partial metabolic response (PR/PMR): LNs/ELSs, ≥50% decrease in the product of perpendicular diameters sum for multiple lesions; no/regressed non-measured lesions, no increase; organ enlargement; NNLs. iwCLL CR: no LNs ≥1.5 cm; spleen size \<13 cm/liver size normal; no constitutional symptoms; normal circulating lymphocyte count (CLC); ≥100 × 10\^9 platelets/L; hemoglobin ≥11 g/dL; normocellular, no CLL cells, no B-lymphoid nodules in marrow. iwCLL PR decrease of ≥50% in lymph nodes, liver and/or spleen, and CLC from baseline; constitutional symptoms; ≥100 × 10\^9 platelets/L or increase of ≥50% over baseline in platelet count and hemoglobin; presence of CLL cells, or of B-lymphoid nodules, or not done.
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University of Alabama At Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States
University of Southern California
Los Angeles, California, United States
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, United States
Community Health Network, Inc.
Indianapolis, Indiana, United States
Norton Cancer Institute
Louisville, Kentucky, United States
Cancer Center For Blood Disorders
Bethesda, Maryland, United States
University of Michigan
Ann Arbor, Michigan, United States
Clinical Research Alliance
New Hyde Park, New York, United States
Ohio State University
Columbus, Ohio, United States
Jefferson University Hospitals
Philadelphia, Pennsylvania, United States
...and 40 more locations
Time frame: up to 1002 days
Cmax of Tafasitamab When Given in Combination With Parsaclisib
Cmax was defined as the maximum observed plasma or serum concentration of tafasitamab.
Time frame: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion
Tmax of Tafasitamab When Given in Combination With Parsaclisib
tmax was defined as the time to the maximum concentration of tafasitamab.
Time frame: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion
AUClast of Tafasitamab When Given in Combination With Parsaclisib
AUClast was defined as the area under the plasma concentration-time curve from time zero to the time of the last measurable concentration.
Time frame: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion
AUC0-inf of Tafasitamab When Given in Combination With Parsaclisib
AUC0-inf was defined as the area under the plasma concentration-time curve from time zero to infinity (time that the drug is no longer present in the body).
Time frame: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion
Clast of Tafasitamab When Given in Combination With Parsaclisib
AUC0-inf was defined as the last measurable plasma drug concentration.
Time frame: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion
t1/2 of Tafasitamab When Given in Combination With Parsaclisib
t1/2 was defined as the drug's elimination half-life, which is the time it takes for the concentration of a drug in the body to decrease by 50%.
Time frame: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion
CL of Tafasitamab When Given in Combination With Parsaclisib
CL was defined as the apparent total body clearance of drug from plasma.
Time frame: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion
VZ of Tafasitamab When Given in Combination With Parsaclisib
Vz was defined as the volume of distribution.
Time frame: Cycle 1 Day 1; before tafasitamab infusion (predose); immediately after tafasitamab infusion; 1 hour and 4 hours post-infusion