Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05371093 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Study of Axicabtagene Ciloleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Follicular Lymphoma

Study acronym: ZUMA-22
StatusActive, Not Recruiting
PhasePhase 3
Started2022-09-22
View on ClinicalTrials.gov ↗

Amendment history

2025-10-14
Study Identification, Study Status, Study Design v31
Start date2022-09-12→2022-09-22
Enrollment targetestimated 230→confirmed 231
2025-05-07
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v30
Trial statusRecruiting→Active, Not Recruiting
Study sites69→52
2025-03-25
Study Status, Contacts/Locations v29
Study sitesdetails revised at 47 of 69 sites
2024-12-20
Study Status, Contacts/Locations v28
Study sitesdetails revised at 3 of 69 sites
2024-11-21
Study Status, Contacts/Locations v27
Study sitesdetails revised at 3 of 69 sites
Show 26 earlier versions
2024-10-18
Study Identification, Study Status, Contacts/Locations v26
Study sitesdetails revised at 5 of 69 sites
2024-09-12
Study Status, Contacts/Locations v25
Study sitesdetails revised at 1 of 69 sites
2024-08-20
Study Status, Contacts/Locations v24
Study sitesdetails revised at 1 of 69 sites
2024-07-25
Study Status v23
Re-verified, no change to tracked fields
2024-06-28
Study Status, Contacts/Locations v22
Study sitesdetails revised at 1 of 69 sites
2024-06-04
Study Status, Contacts/Locations v21
Study sitesdetails revised at 1 of 69 sites
2024-04-29
Study Status, Contacts/Locations v20
Study sites66→69
2024-04-04
Study Status, Contacts/Locations v19
Primary completion date2031-01→2030-10
Completion date2031-01→2030-10
Study sites64→66
2024-02-26
Study Status, Contacts/Locations v18
Study sites58→64
2024-01-31
Study Status, Contacts/Locations v17
Study sites56→58
2023-12-22
Study Status, Eligibility, Contacts/Locations v16
Study sites39→56
Eligibility criteria+8 characters
[...] nt cardiac disease 6 months before randomization Neuropathy Gradegreater 1than orgrade 2 Females who are pregnant or breastfeeding Individuals of [...]
2023-11-28
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility v15
Primary completion date2029-07→2031-01
Completion date2029-07→2031-01
Eligibility criteria+456 characters
[...] 4} Adequate renal, hepatic, pulmonary, and cardiac function Key Exclusion Criteria: TransformedPresence of large B cell lymphoma or transformed FL Small lymphocytic lymphoma Lymphoplasmacytic lymphoma Full-thickness involvement of the gastric wall by lymphoma FL Grade 3b Prior CD19-targeted therapy Prior CAR therapy or [...] atitis B virus or hepatitis C virus History or presence of a clincially significant central nervous system (CNS) disorder. History of autoimmun [...] volvement History of clinically significant cardiac disease within 6 months ofbefore randomization Neuropathy greater than Grade 1 or 2 F [...] [...]
Secondary endpoints15 to 16 entries
Percentage of Participants with Replication-competent Retrovirus in Blood Over time
2023-09-07
Study Status, Contacts/Locations v14
Study sites36→39
2023-08-07
Study Status, Contacts/Locations v13
Study sites28→36
2023-06-20
Study Status, Contacts/Locations v12
Study sites17→28
2023-04-26
Study Status, Contacts/Locations v11
Study sites11→17
2023-03-22
Study Status, Study Description, Contacts/Locations v10
Study sites10→11
2023-02-23
Study Status, Contacts/Locations v9
Study sites8→10
2023-02-03
Study Status, Contacts/Locations v8
Study sites7→8
2022-12-02
Study Status v7
Re-verified, no change to tracked fields
2022-11-11
Study Status, Contacts/Locations v6
Start date2022-09-22→2022-09-12
Study sites4→7
2022-10-07
Study Status, Contacts/Locations v5
Primary completion date2027-04→2029-07
Completion date2029-04→2029-07
Start dateestimated 2022-08→confirmed 2022-09-22
Study sites1→4
2022-08-17
Study Status v4
Re-verified, no change to tracked fields
2022-07-29
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Start date2022-07→2022-08
Study sitesdetails revised at 1 of 1 site
2022-07-26
Study Status, Contacts/Locations v2
Study sites0→1
2022-06-02
Study Status, References v1
2022-05-09
Original filing
The goal of this clinical study is test how well the study drug, axicabtagene ciloleucel, works in participants with relapsed/refractory follicular lymphoma
Trial Details
NCT Number NCT05371093
Lead Sponsor Kite, A Gilead Company
Conditions Relapsed/Refractory Follicular Lymphoma
Enrollment 231 participants
Start Date 2022-09-22
Primary Completion 2030-10 (estimated)
Study Completion 2030-10 (estimated)
Updated on ClinicalTrials.gov 2025-10-15