Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06630104
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-03
Brief Title:
Understanding the Mechanisms of Clonal and Non-clonal Cytopenia Following CAR-T Therapy for Multiple Myeloma or CD19 Lymphoproliferative Disorder LPD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Understanding the Mechanisms of Clonal and Non-Clonal Cytopenia Following CAR-T Therapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 geneticgenomic 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
Detailed Description:
PRIMARY OBJECTIVE
I Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy
SECONDARY OBJECTIVE
I Characterize the baseline transcriptomic signature associated with non-clonal and clonal cytopenia following CAR-T therapy
OUTLINE
Patients undergo bone marrow aspiration and hair and saliva sample collection up to 14 days prior to lymphodepleting LD therapy Patients undergo clinical follow-up CFU on day 90 post-CAR-T therapy Patients with unexplained cytopenia also undergo bone marrow aspiration for sequencing analysis on day 90 and at development of myeloid neoplasm post-cytotoxic therapies MN-pCT during CFU Patients also undergo bone marrow aspiration at determination of clonal 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 up every 90 days for up to 2 years until resolution Patients without unexplained cytopenia are followed clinically for up to 2 years
I Determine the preexisting and therapy-emergent germline and somatic variants associated with an increased risk of clonal and non-clonal cytopenia following CAR-T cell therapy
SECONDARY OBJECTIVE
I Characterize the baseline transcriptomic signature associated with non-clonal and clonal cytopenia following CAR-T therapy
OUTLINE
Patients undergo bone marrow aspiration and hair and saliva sample collection up to 14 days prior to lymphodepleting LD therapy Patients undergo clinical follow-up CFU on day 90 post-CAR-T therapy Patients with unexplained cytopenia also undergo bone marrow aspiration for sequencing analysis on day 90 and at development of myeloid neoplasm post-cytotoxic therapies MN-pCT during CFU Patients also undergo bone marrow aspiration at determination of clonal 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 up every 90 days for up to 2 years until resolution Patients without unexplained cytopenia are followed clinically for up to 2 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None