← Back to Search

Other

T Cell-Depleted Stem Cell Transplant for Leukemia

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)

Must not have

Females who are pregnant or breastfeeding

Life expectancy < 3 months from disease other than acute leukemia or myelodysplastic syndrome (MDS)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 1 and 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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

Select...

I am between 6 months and 22 years old.

Select...

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

Select...

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

Select...

I can care for myself but may need occasional help.

Select...

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

Select...

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

Select...

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

Select...

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

Select...

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

Select...

I am 14 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am not pregnant or breastfeeding.

Select...

I have been told I have less than 3 months to live due to a condition other than acute leukemia or MDS.

Select...

I am allergic to tacrolimus, fludarabine, or methotrexate.

Select...

I have a health condition that makes me unsuitable for a stem cell transplant.

Select...

I have had a stem cell transplant before.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Engraftment of neutrophils by day 28 (Feasibility)

Feasibility achievement

Secondary study objectives

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)

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm I (chemotherapy, naive T-cell depleted PBSC)Experimental Treatment12 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. Additionally, patients undergo ECHO and CSF collection at baseline as well as blood sample collection and bone marrow aspiration with or without biopsy throughout the trial.

Group II: Arm II (chemotherapy, unmanipulated T cell replete BM)Active Control12 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. Additionally, patients undergo ECHO and CSF collection at baseline as well as blood sample collection and bone marrow aspiration with or without biopsy throughout the trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Bone Marrow Aspiration

2011

Completed Phase 2

~1740

Echocardiography

2013

Completed Phase 4

~11580