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Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19+ Lymphoproliferative Disorder (LPD)

StatusRecruiting
PhaseNot applicable
Started2024-11-22
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 24 months later Dec 16, 2027 → Dec 16, 2029
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2027-12-16 → 2029-12-16
Completion pushed: 2027-12-16 → 2031-12-16
2026-08-10
Study Status, Study Description, Arms and Interventions, Eligibility v5
Eligibility criteria+134 characters
[...] al procedure Willingness to provide mandatory hair follicle or skin punch biopsy specimens (skin punch biopsy specimens will be obtained from Mayo Clinic Rochester patients only) for correlative research Willing to return to enrolling ins [...] ctive monitoring phase of the study) Willingness to provide mandatory saliva andor buccal samplesswab sample for correlative research Exclusion Criteria: Ineligible for CAR-T therapy Patients diagnosed with myeloid neoplasm before CAR-T therapy
Study description+14 characters
[...] OUTLINE: Patients undergo bone marrow aspiration and hair, buccalsaliva, andbuccal salivaswab, or skin sample collection up to 14 days prior to lymphodepleting (L [...] of clonal evolution or myeloid neoplasm if not done during CFU on day 90. Patients with unexplained cytopenia at day 90 are [...]
2026-01-06
Study Status v4
Primary completion date2025-12-16→2027-12-16
Completion date2025-12-16→2027-12-16
2025-10-21
Study Status, Study Description, Arms and Interventions, Contacts/Locations v3
Study description-38 characters
[...] clonal and non-clonal cytopenia following CAR-T cell therapy on research basis. SECONDARY OBJECTIVE: I. Characterize the baseline transcri [...] with non-clonal and clonal cytopenia following CAR-T therapy on research basis. OUTLINE: Patients undergo bone marrow aspiration and hair, [...] evolution or myeloid neoplasm if not done during on day 90. Additionally, patients a receive genetic counselor consultation on study. Patients with unexplained cytopenia at day 90 are followed u [...]
Study sitesdetails revised at 6 of 7 sites
2025-10-09
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2025-04-18
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2024-11-16→confirmed 2024-11-22
Eligibility criteria+87 characters
[...] tory bone marrow aspirate specimens for correlative research. All bone marrow aspirate samples are collected during a clinical procedure Willingness to provide mandatory hair follicle specimens for [...] onitoring phase of the study) Willingness to provide saliva and buccal samples for research Exclusion Criteria: Ineligible for CAR- [...]
Study description+9 characters
[...] y. OUTLINE: Patients undergo bone marrow aspiration and hair, buccal, and saliva sample collection up to 14 days prior to lymphod [...]
Study sitesdetails revised at 7 of 7 sites
2024-10-03
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
Multiple Myeloma
1,228 trials monitored
See 75 trials at risk
This clinical trial evaluates the impact of preexisting and therapy-emergent germline and somatic variants on cytopenia in patients with multiple myeloma or CD19 positive lymphoproliferative disorder (LPD) following chimeric antigen receptor T-cell (CAR-T) therapy. The most common adverse event after CAR-T therapy is lower than normal blood cells (cytopenia) and up to one third of patients experience cytopenia that last longer than 30 days post-infusion. Germline and somatic variants are changes in genes found using cancer genomic tests. Cancer genetic/genomic testing is a series of tests that find specific changes in cancer cells or in blood deoxyribonucleic acid. Identifying gene mutations may help identify the risk of cytopenia in patients with multiple myeloma or CD19 positive LPD following CAR-T therapy.
Trial Details
NCT Number NCT06630104
Lead Sponsor Mayo Clinic
Conditions Lymphoproliferative Disorder, Multiple Myeloma
Enrollment 82 participants
Start Date 2024-11-22
Primary Completion 2029-12-16 (estimated)
Study Completion 2031-12-16 (estimated)
Updated on ClinicalTrials.gov 2026-10-01