2023-02-21
notable
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v4
Trial statusRecruiting→Active, Not Recruiting
Primary completion dateestimated 2022-12-31→confirmed 2022-03-13
Completion date2025-12-31→2027-03-13
Study sitesdetails revised at 1 of 1 site
2021-07-23
minor
Study Status, Arms and Interventions, Outcome Measures v3
Secondary endpointsdetails revised at 6 of 6 entries
2021-04-09
minor
Study Status, Study Description, Study Design, Arms and Interventions, Outcome Measures, Eligibility v2
Eligibility criteria+97 characters
[...] r up to 5 years (if received CD19/CD22 CAR-T cell infusion)
March 2021 amendment: Healthy HLA-matched related or haploidentical donor (only for HSCT cohort)
Exclusion Criteria:
<50% expression of both CD19 and CD22 on [...]
Secondary endpoints5 to 6 entries
March 2021 amendment: Incidence of chronic GVHD (only for HSCT cohort)
Primary endpoints5 to 7 entries
March 2021 amendment: incidence of aGVHD grade 2-4 (only for HSCT cohort)
March 2021 amendment: incidence of graft failure before day 100 (only for HSCT cohort)
Study description+383 characters
[...] eshold for excess toxicity or suboptimal effect is achieved.
Based on interim analysis in March 2021 after the enrollment 5th study subject reaches day 28 study population will be divided into three cohorts:
CD19-positive (both CD19 and CD22 expressed on over 50% of leukemia cells), low and high disease burden.
CD19-negative (CD22 expressed on over 50% of le [...]
2020-11-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Study sitesdetails revised at 1 of 1 site
2020-07-31
minor
Original filing