A Study Evaluating Safety, PK, and Efficacy of Tafasitamab and Parsaclisib in Participants With Relapsed/Refractory Non Hodgkin Lymphoma (R/R NHL) or Chronic Lymphocytic Leukemia (CLL)

Browse trials for

• Leukemia, Lymphocytic, Chronic, B-Cell 1,603
• Lymphoma, Non-Hodgkin 1,989
• Recurrence 4,279
• Leukemia 5,441

Keywords

• Relapsed or Refractory
• Leukemia
• tafasitamab
• parsaclisib
• MOR00208
• INCMOR00208

Leukemia, Lymphocytic, Chronic, B-Cell

1,603 studies on the registry are indexed under Leukemia, Lymphocytic, Chronic, B-Cell; 243 are open to participants now.

This study's enrollment of 54 is above the median of 40 across 1,325 interventional studies indexed under Leukemia, Lymphocytic, Chronic, B-Cell.

Lead sponsor

Incyte Corporation is the lead sponsor of 286 studies on the registry; 37 are open to participants now.

Of its 144 completed or terminated interventional studies of FDA-regulated products, 93 (65%) have results posted.

Study arms

• Experimental
  tafasitamab + parsaclisib

  Participants will be assigned to disease specific cohorts based on the histology of their underlying disease. Cohort 1: R/R DLBCL Cohort 2: R/R MCL Cohort 3: R/R FL Cohort 4: R/R MZL Cohort 5: R/R CLL/SLL

  Drug: tafasitamab · Drug: parsaclisib

Interventions

• Drugtafasitamab

  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.

  Also known as: INCMOR00208

• Drugparsaclisib

  parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.

  Also known as: INCB050465

Primary outcomes

1. 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

2. 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

3. 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

4. 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.

   Time frame: up to 1002 days

Secondary outcomes

1. 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

2. 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

3. 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

4. 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

5. 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

6. 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

7. 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

8. 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

Baseline characteristics

Study documents

• Study protocol · Sep 13, 2022
• Statistical analysis plan · Mar 31, 2022

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — 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 information: Study protocol, Sap