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NGS Monitoring for Acute Lymphoblastic Leukemia

N/A

Recruiting

Led By Nirali N Shah, M.D.

Research Sponsored by National Cancer Institute (NCI)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 year post cd19 cart infusion

Awards & highlights

Study Summary

This trial will test whether tests of blood & tissue can help predict B-ALL relapse after CART therapy & whether HCT is needed.

Who is the study for?

This trial is for children and young adults aged 1 to 25 with B-ALL who have recently undergone CART therapy but haven't had a stem cell transplant. They should be in remission, without measurable cancer cells, and have an identified donor for potential future HCT.Check my eligibility

What is being tested?

The study tests if regular blood and bone marrow NGS testing after CART therapy can predict relapse in B-ALL patients. It aims to determine the necessity of additional treatments like HCT by monitoring B-cell recovery.See study design

What are the potential side effects?

While the trial focuses on testing rather than treatment, procedures include blood draws and bone marrow biopsies which may cause discomfort, bleeding, or infection at the puncture site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 year post cd19 cart infusion

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1 year post cd19 cart infusion

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 year post cd19 cart infusion for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy of novel biomarker-guided risk based strategy to monitor remission

Secondary outcome measures

Leukemia

Overall survival

Time to HCT

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: 1/InterventionExperimental Treatment1 Intervention

Systematic, frequent monitoring intervention to risk stratify pts for risk of relapse postCART

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)Lead Sponsor

13,667 Previous Clinical Trials

40,926,022 Total Patients Enrolled

Nirali N Shah, M.D.Principal InvestigatorNational Cancer Institute (NCI)

13 Previous Clinical Trials

2,469 Total Patients Enrolled

Media Library

1/Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05621291 — N/A

Acute Lymphoblastic Leukemia Research Study Groups: 1/Intervention

Acute Lymphoblastic Leukemia Clinical Trial 2023: 1/Intervention Highlights & Side Effects. Trial Name: NCT05621291 — N/A

1/Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05621291 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could I potentially qualify to take part in this research endeavor?

"This medical trial is accepting 60 participants aged between 1 and 25 displaying b-lymphocytes, as well as fulfilling additional criteria: being NGS clonality sample positive for MRD assessment; negative NGS MRD rating within 42 days post CD19 CART infusion and before the first on-study intervention; having received their first 4-1BB based construct (Kymriah or an equivalent) not exceeding 42 days beforehand; confirmation of a CD19+ B-ALL diagnosis with an informative NGS clonality sample; bone marrow morphologic complete remission plus flow cytometry measurable residual disease negativity within the previously mentioned period of"

Answered by AI

Are there any available openings in this research endeavor?

"Clinicaltrials.gov indicates that this trial, which was originally published on December 11th 2022 and last updated five days later, is not currently enrolling new patients. However, there are an abundance of other clinical trials actively recruiting right now with a total of 1497 open studies in progress."

Answered by AI

Are octogenarians able to enroll in this experiment?

"The requirements for participating in this trial hinge on the patient's age, with inclusion limited to those between 1 year and 25 years old. Subsequently, 465 clinical trials are available to minors while 1188 studies have been designed for seniors."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leu...

2024. "A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leu...". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05621291.