A Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy
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|ClinicalTrials.gov Identifier: NCT04071366|
Recruitment Status : Recruiting
First Posted : August 28, 2019
Last Update Posted : April 13, 2021
|Condition or disease||Intervention/treatment||Phase|
|Cytokine Release Syndrome||Drug: Itacitinib Drug: Immune effector cell therapy||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||62 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2, Single-Arm, Open-Label Study of Itacitinib for the Prevention of Cytokine Release Syndrome Induced by Immune Effector Cell Therapy|
|Actual Study Start Date :||February 7, 2020|
|Estimated Primary Completion Date :||March 15, 2022|
|Estimated Study Completion Date :||March 15, 2022|
Itacitinib 200 mg once daily for 30 days.
Other Name: INCB039110
Drug: Immune effector cell therapy
Participants will receive IEC therapy that is approved by the health authority in the country where the study is being conducted for any approved hematologic indication.
- Proportion of participants who develop ≥ Grade 2 CRS [ Time Frame: Day 14 ]Assessed using American Society for Blood and Marrow Transplantation (ASBMT) CRS Consensus Grading.
- Proportion of participants with immune effector cell-associated neurotoxicity syndrome (ICANS) after IEC therapy [ Time Frame: Day 28 ]Assessed using the ICANS Consensus Grading.
- Duration of ICANS regardless of CRS [ Time Frame: Day 28 ]Assessed using the ICANS Consensus Grading.
- Duration of all grades of CRS [ Time Frame: Day 28 ]Assessed using ASBMT CRS Consensus Grading.
- Proportion of participants with any grade of CRS after IEC therapy [ Time Frame: 48 hours ]Assessed using ASBMT CRS Consensus Grading.
- Proportion of participants with ≥ Grade 2 CRS after first IEC therapy [ Time Frame: Day 28 ]Assessed using ASBMT CRS Consensus Grading.
- Number of treatment-emergent adverse events [ Time Frame: Day -3 through safety follow-up, up to approximately 60 days. ]Defined as adverse events reported for the first time or worsening of a pre-existing event after first dose of itacitinib.
- Number of hospital admissions for participants with CRS and/or ICANS [ Time Frame: Through end of study, up to 180 days. ]
- Duration of hospital stay for participants with CRS and/or ICANS [ Time Frame: Through end of study, up to 180 days. ]
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): NCT04071366
|Contact: Incyte Corporation Call Center (US)||firstname.lastname@example.org|
|United States, Florida|
|University of Miami Sylvester Comprehensive Cancer Center||Recruiting|
|Miami, Florida, United States, 33136|
|Moffitt Cancer Center||Recruiting|
|Tampa, Florida, United States, 33612|
|United States, Kansas|
|The University of Kansas Cancer Center||Not yet recruiting|
|Westwood, Kansas, United States, 66205|
|United States, Massachusetts|
|Massachusetts General Hospital||Recruiting|
|Boston, Massachusetts, United States, 02114|
|United States, Missouri|
|Washington University School of Medicine||Recruiting|
|Saint Louis, Missouri, United States, 63110|
|United States, New York|
|Columbia University Medical Center||Recruiting|
|New York, New York, United States, 10032|
|Memorial Sloan Kettering Cancer Center||Recruiting|
|New York, New York, United States, 10065|
|United States, Ohio|
|Cincinnati Childrens Hospital Medical Center||Recruiting|
|Cincinnati, Ohio, United States, 45229|
|United States, Oregon|
|Oregon Health & Science University||Recruiting|
|Portland, Oregon, United States, 97239|
|United States, Pennsylvania|
|University of Pennsylvania Hospital||Recruiting|
|Philadelphia, Pennsylvania, United States, 19104|
|United States, Wisconsin|
|Medical College of Wisconsin||Recruiting|
|Milwaukee, Wisconsin, United States, 53226|
|Study Director:||Peter Langmuir, MD||Incyte Corporation|