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Hematopoietic Stem Cell Transplantation

Stem Cell Transplant for Pediatric Blood Cancers

Q: Is geriatric participation being considered for this clinical investigation?

This clinical trial requires that prospective participants be aged between 31 days and 30 years. There are 65 spots open for patients below the age of majority and 236 trials offered to seniors over 65.

Q: What degree of security is provided by CliniMACS Plus Instrument to patients?

We assigned CliniMACS Plus Instrument a safety score of 2 due to the fact that while there is evidence available on its safety, no studies have yet been conducted to confirm efficacy.

Q: Is enrolment still open for this medical experiment?

Contrary to what is indicated on clinicaltrials.gov, this medical study has concluded recruitment efforts as of June 29th 2022. Initially posted in December 1st 2022, 265 other trials are currently seeking applicants at present.

Q: To whom does this medical trial appeal most?

This trial is currently seeking 50 patients aged between one month and 30 years old who have hematologic neoplasms. To be eligible, applicants must possess the following prerequisites: Age 31 days to &#x3C;30 years; remission from acute <a href="https://www.withpower.com/clinical-trials/leukemia">leukemia</a> (<a href="https://www.withpower.com/clinical-trials/mds">MDS</a>/<a href="https://www.withpower.com/clinical-trials/aml">AML</a> excluded) or <a href="https://www.withpower.com/clinical-trials/lymphoma">lymphoma</a>; lack of a healthy and willing HLA-identical related donor with exception for those with Fanconi anemia; access to either a related or unrelated donor that meets selection criteria, is able healthily receive GCSF wither alone or alongside Plerixafor, as well as undergo apheresis through placement of catheters

Phase 2

Waitlist Available

Led By Alisa B Lee Sherick

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Clinical remission for patients with acute leukemia (MDS/AML excluded) or lymphoma

Age 31 days to <30 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study Summary

This trial is testing a new type of allogeneic HCT (hematopoietic stem cell transplant) that uses TCR alpha/beta- and CD19-depleted cells in pediatric patients with hematologic disease.

Who is the study for?

This trial is for pediatric patients aged 31 days to under 30 years with various blood cancers or hematologic conditions who lack a healthy, matching donor. Participants need informed consent, must not be HIV positive, pregnant, or have significant heart, kidney, lung or liver issues.Check my eligibility

What is being tested?

The study tests the CliniMACS Plus Instrument's effectiveness in TCR alpha/beta and CD19-depleted haploidentical stem cell transplantation (Haplo-HSCT) for treating hematologic diseases in children and young adults.See study design

What are the potential side effects?

Potential side effects may include reactions related to immune system suppression such as increased infection risk and complications from the transplant procedure itself.

Eligibility Criteria

Inclusion Criteria

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

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My leukemia or lymphoma is currently in remission.

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I am between 1 month and 30 years old.

Select...

I have a blood disorder that may improve with a stem cell transplant.

Select...

I am over 18 and can consent, or if under 18, I have a guardian who can.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Incidence of severe (grade III-IV) acute graft-versus-host disease (GVHD) at day 100 after infusion of a TCRαβ+/CD19+ negative, peripheral blood stem cell (PBSC) product without additional GVHD prophylaxis.

Secondary outcome measures

Disease-free Survival (DFS) measured in days

Immune Reconstitution

Number of patients with non-engraftment

+4 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Pediatric patients with malignant or non-malignant hematologic conditionExperimental Treatment1 Intervention

The infusion of the final TCRαβ/CD19 depleted product will be given through the recipient's central venous catheter and will be administered fresh, without cryopreservation whenever possible. If the product must be cryopreserved and then thawed, this will be done according to institutional standards.

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,533 Total Patients Enrolled

2 Trials studying Pediatrics

69 Patients Enrolled for Pediatrics

Alisa B Lee SherickPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

TCR alpha/beta and CD19-depeleted allogeneic HCT (Hematopoietic Stem Cell Transplantation) Clinical Trial Eligibility Overview. Trial Name: NCT05288595 — Phase 2

Pediatrics Research Study Groups: Pediatric patients with malignant or non-malignant hematologic condition

Pediatrics Clinical Trial 2023: TCR alpha/beta and CD19-depeleted allogeneic HCT Highlights & Side Effects. Trial Name: NCT05288595 — Phase 2

TCR alpha/beta and CD19-depeleted allogeneic HCT (Hematopoietic Stem Cell Transplantation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05288595 — Phase 2

Frequently Asked Questions

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

Is geriatric participation being considered for this clinical investigation?

"This clinical trial requires that prospective participants be aged between 31 days and 30 years. There are 65 spots open for patients below the age of majority and 236 trials offered to seniors over 65."

Answered by AI

What degree of security is provided by CliniMACS Plus Instrument to patients?

"We assigned CliniMACS Plus Instrument a safety score of 2 due to the fact that while there is evidence available on its safety, no studies have yet been conducted to confirm efficacy."

Answered by AI

Is enrolment still open for this medical experiment?

"Contrary to what is indicated on clinicaltrials.gov, this medical study has concluded recruitment efforts as of June 29th 2022. Initially posted in December 1st 2022, 265 other trials are currently seeking applicants at present."

Answered by AI

To whom does this medical trial appeal most?

"This trial is currently seeking 50 patients aged between one month and 30 years old who have hematologic neoplasms. To be eligible, applicants must possess the following prerequisites: Age 31 days to <30 years; remission from acute leukemia (MDS/AML excluded) or lymphoma; lack of a healthy and willing HLA-identical related donor with exception for those with Fanconi anemia; access to either a related or unrelated donor that meets selection criteria, is able healthily receive GCSF wither alone or alongside Plerixafor, as well as undergo apheresis through placement of catheters"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

TCR Alpha/Beta and CD19-deplete Haplo-HSCT

2024. "TCR Alpha/Beta and CD19-deplete Haplo-HSCT". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05288595.