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Cell Depletion

HSCT using TCR αβ/CD19+ depleted grafts for Blood Cancers (TB19DHCT Trial)

N/A

Recruiting

Research Sponsored by Nationwide Children's Hospital

Eligibility Criteria Checklist

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

Must have

Age ≤ 30 years

Patients who will benefit from an allogenic stem cell transplant to treat underlying primary hematological malignancy and lacks a suitably available matched sibling donor

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

TB19DHCT Trial Summary

"This trial is testing a new device called CliniMACS® Alpha-Beta T-cell/CD19 depletion for children and young adults with blood cancers who are having a stem cell transplant from a donor

Who is the study for?

This trial is for children and young adults up to 30 years old with blood cancers who need a bone marrow transplant but don't have a matched sibling donor. They should be in good health otherwise, able to tolerate the transplant process, and have an acceptable performance status score.Check my eligibility

What is being tested?

The study tests CliniMACS® device's ability to deplete specific immune cells (αβT/CD19+ B cells) from stem cell grafts before transplantation. It aims to see if this can help patients accept cells from partially matched or unrelated donors without complications.See study design

What are the potential side effects?

Possible side effects may include reactions related to the immune system being weakened by cell depletion, such as increased risk of infections, and those associated with granulocyte-colony stimulating factor administration.

TB19DHCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 30 years old or younger.

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I need a stem cell transplant for my blood cancer and don't have a matching sibling donor.

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I am mostly independent and can care for myself.

TB19DHCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

One-year overall survival of patients undergoing allogeneic HSCT using the T-Cell Receptor (TCR) αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)

Secondary outcome measures

1 year Event free survival

100 day and 1 year Transplant related mortality

Incidence grade III-IV acute graft versus host disease (GVHD)

+3 more

TB19DHCT Trial Design

1Treatment groups

Experimental Treatment

Group I: HSCT using TCR αβ/CD19+ depleted graftsExperimental Treatment1 Intervention

Allogeneic HSCT using the TCR αβ/CD19+ depleted platform and grafts from alternative donors (MUD, MMUD and haploidentical)

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Nationwide Children's HospitalLead Sponsor

341 Previous Clinical Trials

5,220,456 Total Patients Enrolled

Frequently Asked Questions

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

Are there any available positions for patients to participate in this clinical trial?

"The information available on clinicaltrials.gov confirms that this research study is currently in the process of enrolling participants. This trial was initially listed on December 18, 2023 and most recently revised on February 15, 2024."

Answered by AI

How many individuals in total are involved as participants in this research investigation?

"Affirmative. Information from clinicaltrials.gov highlights that this research project is currently seeking volunteers for participation. The trial was initially disclosed on December 18th, 2023, and the most recent update was made on February 15th, 2024. This study aims to enroll a total of 50 individuals at one designated site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)

2023. "αβT Cell/CD19+ B Cell Depletion for Alternative Donor Allogeneic Hematopoietic Cell Transplantation (HSCT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06082947.