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) (topMIND)
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|ClinicalTrials.gov Identifier: NCT04809467|
Recruitment Status : Active, not recruiting
First Posted : March 22, 2021
Last Update Posted : September 22, 2022
|Condition or disease||Intervention/treatment||Phase|
|Chronic Lymphocytic Leukemia Non Hodgkin Lymphoma||Drug: tafasitamab Drug: parsaclisib||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Masking Description:||Open Label|
|Official Title:||A Phase 1b/2a Basket Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of Combination Therapy With the Anti CD19 Monoclonal Antibody Tafasitamab and the PI3Kδ Inhibitor Parsaclisib in Adult Participants With Relapsed/Refractory Non Hodgkin Lymphoma or Chronic Lymphocytic Leukemia|
|Actual Study Start Date :||September 16, 2021|
|Estimated Primary Completion Date :||October 31, 2023|
|Estimated Study Completion Date :||October 31, 2023|
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
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.
Other Name: INCMOR00208
parsaclisib will be administered at protocol defined dose for cycles 1 through disease progression.
Other Name: INCB050465
- Phase 1b : Number of Treatment Emergent Adverse Events [ Time Frame: Up to 25 months ]Any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
- Phase 1b : Incidence of Dose Limiting Toxicities [ Time Frame: 28 Days ]Dose-limiting toxicity will be defined as the occurrence of any of the toxicities as per protocol. All DLTs will be assessed for severity by the investigator using CTCAE v5.0 criteria.
- Phase 2a : Overall Response Rate [ Time Frame: Up to 25 months ]Defined as the percentage of participants experiencing a best response of Complete Response/Complete Metabolic Response (CR/CMR) or Partial Response/Partial Metabolic Response (PR/PMR) according to the Lugano criteria (Cheson et al 2014) for NHL and the iwCLL criteria (Hallek et al 2018) for CLL.
- Pharmacokinetics Parameter : Cmax of tafasitamab [ Time Frame: Up to 24 months ]Maximum Observed Plasma Concentration of tafasitamab
- Pharmacokinetics Parameter : Cmin of tafasitamab [ Time Frame: Up to 24 months ]Minimum Observed Plasma Concentration of tafasitamab
- Pharmacokinetics Parameter : Tmax of tafasitamab [ Time Frame: Up to 24 months ]Time to reach maximum plasma concentration of tafasitamab
- Pharmacokinetics Parameter : AUC(t) of tafasitamab [ Time Frame: Up to 24 months ]Area under the concentration-time curve from time zero to time of tafasitamab
- Pharmacokinetics Parameter : Ctrough of tafasitamab [ Time Frame: Up to 24 months ]C trough concentration of tafasitamab
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04809467
|Study Director:||Oliver Manzke, MD||Incyte Corporation|