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Cell Therapy

Allogeneic stem cell transplant with ⍺/β CD3+ T-cell and CD19+ B-cell depleted graft for Acute Lymphoblastic Leukemia

Phase 2
Recruiting
Led By Jordan Milner, MD
Research Sponsored by University of Florida
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 2 years
Awards & highlights

Study Summary

This trial will test a new method of stem cell transplantation for patients with certain types of leukemia and lymphoma. The study will look at how safe and effective it is to remove certain types of cells from

Who is the study for?
This trial is for patients with certain blood cancers like ALL, AML, CML, lymphoma and high-risk MDS. Participants should be in specific stages of their disease such as first or second remission or have a limited amount of cancer cells in the bone marrow. It's not open to those who don't meet these specific conditions.Check my eligibility
What is being tested?
The study tests a stem cell transplant technique using the Miltenyi CliniMACS Prodigy system to remove certain immune cells (⍺/β CD3+ T-cells and CD19+ B-cells) from donor cells before transplantation into patients with various malignant diseases.See study design
What are the potential side effects?
Potential side effects may include complications related to stem cell transplants such as infections due to weakened immunity, graft-versus-host disease where donor cells attack the body, and reactions during infusion.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Acute graft versus host disease (aGVHD) incidence
Secondary outcome measures
Adenovirus viremia incidence
Cytomegalovirus (CMV) viremia incidence
Epstein-Barr virus (EBV) viremia incidence
+4 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Allogeneic stem cell transplant with ⍺/β CD3+ T-cell and CD19+ B-cell depleted graftExperimental Treatment1 Intervention

Find a Location

Who is running the clinical trial?

Florida Department of HealthOTHER_GOV
28 Previous Clinical Trials
12,983 Total Patients Enrolled
University of FloridaLead Sponsor
1,342 Previous Clinical Trials
715,653 Total Patients Enrolled
Jordan Milner, MDPrincipal InvestigatorUniversity of Florida
2 Previous Clinical Trials
60 Total Patients Enrolled

Frequently Asked Questions

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

Is the research study open to individuals younger than 20 years old?

"Participants as young as 6 months old and up to the age of 39 are eligible for enrollment based on the inclusion criteria outlined for this research study."

Answered by AI

What criteria are used to determine eligibility for participation in this medical study?

"This research trial is open for enrollment to 20 individuals aged between 6 months and 39 years who are presently diagnosed with acute lymphoblastic leukemia. Eligible participants must satisfy the subsequent conditions: ii. AML, i. ALL, AML displaying persistent minimal residual disease (MRD) in CR1(≥0.01% on flow or continuing abnormal karyotype observed via cytogenetics), AML CR2 onwards, AML facing refractory relapse but having ≤15% bone marrow leukemia blasts, High-risk ALL encompassing any of the following characteristics: (t(9;22) or presence of"

Answered by AI

What is the safety profile of Allogeneic stem cell transplant with ⍺/β CD3+ T-cell and CD19+ B-cell depleted graft for individuals?

"Our team at Power rates the safety of Allogeneic stem cell transplant with ⍺/β CD3+ T-cell and CD19+ B-cell depleted graft as 2 on a scale from 1 to 3. This evaluation is based on the current Phase 2 trial status, where some evidence exists supporting safety but not efficacy."

Answered by AI

Are participants currently being recruited for this trial?

"As per details on clinicaltrials.gov, recruitment for this trial is not ongoing. The study was initially listed on April 1st, 2024 and last revised on February 19th, 2024. Although this particular trial is closed for enrollment, there are currently 3099 other studies actively seeking participants."

Answered by AI
~13 spots leftby May 2026