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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
No Placebo-Only Group
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.
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.
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Efficacy of novel biomarker-guided risk based strategy to monitor remission
Secondary study objectives
Leukemia
Overall survival
Time to HCT
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,958 Previous Clinical Trials
41,112,520 Total Patients Enrolled
Nirali N Shah, M.D.Principal InvestigatorNational Cancer Institute (NCI)
13 Previous Clinical Trials
2,507 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a stem cell transplant before.My leukemia is CD19 positive according to a specific genetic test.I need ongoing treatment or monitoring for my brain condition.I have a history of cancer outside the bone marrow that doesn't need constant monitoring.I am between 1 and 25 years old.My cancer's genetic changes are trackable with a blood or bone marrow test.
Research Study Groups:
This trial has the following groups:- Group 1: 1/Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.