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T Cell-Depleted Stem Cell Transplant for Leukemia

Q: Does the age requirement for this investigation preclude those under 45 from participating?

According to the terms of participation, any patient aged between 6 months and 22 years is eligible for enrollment in this trial.

Q: Is Tacrolimus being tested in any other clinical experiments?

Initially studied in 1997, tacrolimus has seen extensive clinical trials with a total of 2169 completed studies. At present, 1123 additional investigations are ongoing around the globe - particularly within Boston <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a>.

Q: Are any vacancies available for individuals to partake in this research?

It is evident from the clinicaltrials.gov database that recruitment for this trial has yet to be concluded. The primary date of posting was August 29th 2019 and it was last modified on August 19th 2022.

Q: How many individuals are currently participating in this scientific experiment?

This clinical trial necessitates the involvement of 68 eligible candidates. They can sign-up to take part at Dana Farber / Boston Children's Hospital in <a href="https://www.withpower.com/clinical-trials/massachusetts">Massachusetts</a> and UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center) located in <a href="https://www.withpower.com/clinical-trials/ohio">Ohio</a>.

Phase 2

Recruiting

Led By Marie Bleakley

Research Sponsored by Fred Hutchinson Cancer Research Center

Eligibility Criteria Checklist

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

Must have

Age 6 months to 22 years at the time informed consent

Planned product type for infusion is PBSC or BM (i.e. not cord blood)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 and 2 years

Awards & highlights

Study Summary

This trial is testing whether removing a type of T cell from donor cells before a transplant can prevent graft-versus-host disease.

Who is the study for?

This trial is for children and young adults aged 6 months to 22 years with certain blood cancers who need a stem cell transplant. They must have good heart function, lung capacity, liver and kidney function, and not be pregnant or breastfeeding. Participants need a matched donor available in the US.Check my eligibility

What is being tested?

The study tests if removing naive T-cells from donor cells before transplant can prevent chronic graft-versus-host disease in patients undergoing stem cell transplants for blood cancer treatment.See study design

What are the potential side effects?

Potential side effects include reactions to medications like tacrolimus, fludarabine, methotrexate (such as allergies), increased risk of infections due to immune suppression, and complications related to organ functions.

Eligibility Criteria

Inclusion Criteria

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

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I am between 6 months and 22 years old.

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My planned infusion will use stem cells from bone marrow or blood, not cord blood.

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I have a donor who is a perfect match for my bone marrow transplant.

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I can care for myself but may need occasional help.

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My donor's MRD tests were done in a certified lab with approved kits.

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I have a specific type of leukemia or myelodysplastic syndrome and am eligible for a stem cell transplant.

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My donor is free from HIV, HTLV-1, HTLV-2, hepatitis B, and hepatitis C.

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My donor is a perfect match for me in all 8 important genetic markers.

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My donor's tests were done in a certified lab with approved kits.

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My lung function test shows a DLCO of 60% or higher.

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My kidney function, measured by creatinine levels or clearance, is within the normal range.

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I am 14 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 1 and 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 1 and 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 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

Current-graft versus host disease (GVHD)-free, relapse-free survival (Randomized Controlled Trial [RCT])

Engraftment of neutrophils by day 28 (Feasibility)

Feasibility achievement

Secondary outcome measures

Chronic GVHD (cGVHD) meeting National Institutes of Health (NIH) criteria and requiring prednisone (RCT)

Proportion of subjects alive and off prednisone (or equivalent systemic corticosteroid) for treatment of GVHD (RCT)

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (chemotherapy, naive T-cell depleted PBSC)Experimental Treatment8 Interventions

CONDITIONING REGIMEN A: Patients undergo TBI BID on days -10 to -7, then receive thiotepa IV over 3 hours QD on days -6 and -5, and fludarabine IV over 30 minutes once daily on days -6 to -2. CONDITIONING REGIMEN B: Patients undergo TBI BID on days -8 to -5, then receive fludarabine IV over 30 minutes QD on days -4 to -2, and cyclophosphamide IV over 1 hour QD on days -3 and -2. CONDITIONING REGIMEN C: Patients receive fludarabine IV over 30 minutes QD on days -6 to -2, busulfan IV over 180 minutes QD on days -5 to -2, and undergo total body irradiation BID on day -1. TRANSPLANT: Patients receive naive T-cell depleted PBSCs on day 0. GVHD PROPHYLAXIS: All patients receive tacrolimus IV beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11.

Group II: Arm II (chemotherapy, unmanipulated T cell replete BM)Active Control8 Interventions

CONDITIONING REGIMEN A: Patients undergo TBI BID on days -10 to -7, then receive thiotepa IV over 3 hours QD on days -6 and -5, and fludarabine IV over 30 minutes once daily on days -6 to -2. CONDITIONING REGIMEN B: Patients undergo TBI BID on days -8 to -5, then receive fludarabine IV over 30 minutes QD on days -4 to -2, and cyclophosphamide IV over 1 hour QD on days -3 and -2. CONDITIONING REGIMEN C: Patients receive fludarabine IV over 30 minutes QD on days -6 to -2, busulfan IV over 180 minutes QD on days -5 to -2, and undergo total body irradiation BID on day -1. TRANSPLANT: Patients receive unmanipulated T cell-replete BM on day 0. GVHD PROPHYLAXIS: All patients receive tacrolimus IV beginning on day -1 and methotrexate IV on days 1, 3, 6, and 11.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Thiotepa

2008

Completed Phase 3

~2150

Busulfan

2008

Completed Phase 3

~1120

Cyclophosphamide

1995

Completed Phase 3

~3770

Methotrexate

2013

Completed Phase 4

~3800

Tacrolimus

2011

Completed Phase 4

~4740

Total-Body Irradiation

1997

Completed Phase 3

~1180

0 / 12Eligibility criteria met

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,177 Total Patients Enrolled

2 Trials studying Aplastic Anemia

51 Patients Enrolled for Aplastic Anemia

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,200 Total Patients Enrolled

3 Trials studying Aplastic Anemia

96 Patients Enrolled for Aplastic Anemia

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,599 Total Patients Enrolled

8 Trials studying Aplastic Anemia

998 Patients Enrolled for Aplastic Anemia

Media Library

Allogeneic Bone Marrow Transplantation (Other) Clinical Trial Eligibility Overview. Trial Name: NCT03779854 — Phase 2

Frequently Asked Questions

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

What conditions are commonly treated with Tacrolimus?

"Tacrolimus is typically prescribed to combat small cell lung cancer. However, it has also been found useful in managing dermatitis, atopic dermatitis, multiple sclerosis, leukemia and myelocytic or acute conditions."

Answered by AI

Is the application of Tacrolimus to patients well-tolerated?

"Following an assessment, Tacrolimus was rated a 2 for safety as this is Phase 2 trial and though there have been some investigations into the drug's security there has yet to be clinical evidence supporting its efficacy."

Answered by AI

How many distinct sites are responsible for administering this experiment?

"This research trial is recruiting patients from Dana Farber / Boston Children's Hospital in Boston, Massachusetts; UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center) in Cleveland, Ohio; University of Iowa Stead Family Children's Hospital in Atlanta, Georgia; and 10 other sites."

Answered by AI

Who is most suited to volunteer for this medical experiment?

"This clinical trial seeks 68 individuals between 6 months and 22 years old with acute biphenotypic leukemia. Essential criteria for patient selection include: having < 5% marrow blasts in Acute lymphoblastic leukemia (ALL) or < 25% in Acute myeloid leukemia (AML), meeting the requirements of Other acute leukemias such as ambiguous lineage, mixed phenotype acutte leukemia, blastic plasmacytoid dendritic cell neoplasm, and acute undifferentiated leukemia; Myelodysplastic syndrome must present excess blasts EB-1 and EB-2 after chemotherapy treatment be administered; a"

Answered by AI

Does the age requirement for this investigation preclude those under 45 from participating?

"According to the terms of participation, any patient aged between 6 months and 22 years is eligible for enrollment in this trial."

Answered by AI

Is Tacrolimus being tested in any other clinical experiments?

"Initially studied in 1997, tacrolimus has seen extensive clinical trials with a total of 2169 completed studies. At present, 1123 additional investigations are ongoing around the globe - particularly within Boston Massachusetts."

Answered by AI

Are any vacancies available for individuals to partake in this research?

"It is evident from the clinicaltrials.gov database that recruitment for this trial has yet to be concluded. The primary date of posting was August 29th 2019 and it was last modified on August 19th 2022."

Answered by AI

How many individuals are currently participating in this scientific experiment?

"This clinical trial necessitates the involvement of 68 eligible candidates. They can sign-up to take part at Dana Farber / Boston Children's Hospital in Massachusetts and UH Rainbow Babies and Children's Hospital (University Hospitals Cleveland Medical Center) located in Ohio."

Answered by AI

Recent research and studies

Blood AdvancesJournal

Naive T-cell Depletion in Stem Cell Transplantation

Bleakley, Marie. 2020. “Naive T-cell Depletion in Stem Cell Transplantation”. Blood Advances. American Society of Hematology. doi:10.1182/bloodadvances.2020001888.

clinicaltrials.govStudy

Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant

2019. "Naive T Cell Depletion for Preventing Chronic Graft-versus-Host Disease in Children and Young Adults With Blood Cancers Undergoing Donor Stem Cell Transplant". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03779854.

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