Relmacabtagene Autoleucel in Hematologic Malignancies
A Real-world Study for the Treatment of Hematologic Malignancies With Relmacabtagene Autoleucel
1 other identifier
observational
150
1 country
2
Brief Summary
To evaluate the efficacy and safety of Relmacabtagene Autoleucel in the treatment of adult patients with hematologic malignancies in real-world
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2023
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2023
CompletedFirst Posted
Study publicly available on registry
November 21, 2023
CompletedStudy Start
First participant enrolled
December 28, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2038
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2038
November 21, 2023
November 1, 2023
15 years
November 15, 2023
November 15, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ORR
Percentage of participants with CR \[CMR;CRR\] or PR \[partial metabolic response (PMR);
15 years
Secondary Outcomes (5)
CRR
15 years
Duration of response (DOR)
15 years
Progression-Free Survival (PFS)
15 years
Overall Survival (OS)
15 years
Adverse events (AEs)
15 years
Study Arms (1)
Relmacabtagene Autoleucel
Relmacabtagene Autoleucel administered as a single IV infusion at a target dose of 1 x 10\^8 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day1.
Interventions
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells
Eligibility Criteria
Hematologic Malignancies
You may qualify if:
- Signed informed consent
- Patients who have been treated with Relma-cel, including those who have received off-label products;
- If previously enrolled in another clinical study, they must have completed follow-up in the previous study, or have withdrawn or lost follow-up in the previous study.
You may not qualify if:
- Patients who have been treated with Relma-cel and then have been treated with other CAR-T products.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100010, China
Peking University International Hospital
Beijing, Beijing Municipality, 100010, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2023
First Posted
November 21, 2023
Study Start
December 28, 2023
Primary Completion (Estimated)
December 31, 2038
Study Completion (Estimated)
December 31, 2038
Last Updated
November 21, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will not share