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T Cell Depletion

Total-Body Irradiation for Acute Lymphoblastic Leukemia

Phase 2

Waitlist Available

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

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing whether T cell depleted donor peripheral blood stem cell transplant can help prevent graft-versus-host disease, which sometimes happens when donor cells are transplanted.

Eligible Conditions

Acute Lymphoblastic Leukemia
Biphenotypic Leukemia
Myelodysplastic Syndrome
Acute Myeloid Leukemia
Chronic Myelogenous Leukemia
Childhood Acute Myeloid Leukemia
Acute Leukemia
Acute Undifferentiated Leukemia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

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

Graft Failure

Time to Discontinuation of Systemic Immunosuppression

Secondary outcome measures

Acute GVHD Grade III-IV

Acute GVHD Grades II-IV

Occurrence of Chronic GHVD Meeting NIH Criteria and Requiring Systemic Pharmacological Immunosuppression

+8 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (CD45RA+ T cell depleted PBSCT)Experimental Treatment9 Interventions

CONDITIONING REGIMEN: Patients undergo TBI BID on days -10 to -7, receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: Patients undergo CD34+ enriched, CD45RA+ T cell-depleted allogeneic PBSCT on day 0. POST-TRANSPLANT IMMUNOSUPPRESSION: Patients receive tacrolimus IV continuously or PO every 12 hours beginning on day -1 and continuing through day 50 with taper. Patients also receive methotrexate IV on days 1, 3, 6, and 11.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methotrexate

2013

Completed Phase 4

~3800

Tacrolimus

2011

Completed Phase 4

~4740

Peripheral Blood Stem Cell Transplantation

1997

Completed Phase 3

~1330

Total-Body Irradiation

1997

Completed Phase 3

~1180

T Cell-Depleted Hematopoietic Stem Cell Transplantation

2014

Completed Phase 2

~40

Thiotepa

2008

Completed Phase 3

~2150

Allogeneic Hematopoietic Stem Cell Transplantation

2012

Completed Phase 2

~1200

Fludarabine Phosphate

1997

Completed Phase 3

~2390

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor

443 Previous Clinical Trials

148,225 Total Patients Enrolled

Fred Hutchinson Cancer CenterLead Sponsor

556 Previous Clinical Trials

1,343,248 Total Patients Enrolled

National Cancer Institute (NCI)NIH

13,654 Previous Clinical Trials

40,933,133 Total Patients Enrolled

Frequently Asked Questions

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

How many individuals has the trial enrolled thus far?

"This trial is no longer accepting patients; the study was first published on December 17th 2013 and last updated June 28th 2022. Currently, 3768 studies with relapse related research are still recruiting participants as well as 676 trials focused on T Cell-Depleted Hematopoietic Stem Cell Transplantation."

Answered by AI

Is enrollment currently open for this experiment?

"As indicated by clinicaltrials.gov, this trial is not presently enrolling patients; the initial posting was on December 17th 2013 and it last updated June 28th 2022. Nevertheless, there are 4444 other trials currently recruiting participants."

Answered by AI

Are there any potential hazards associated with T Cell-Depleted Hematopoietic Stem Cell Transplantation?

"Our team assessed T Cell-Depleted Hematopoietic Stem Cell Transplantation to have a safety rating of 2. As it is a Phase 2 trial, clinical data does back its safety but there is no evidence for efficacy yet."

Answered by AI

Have there been any prior experiments on T Cell-Depleted Hematopoietic Stem Cell Transplantation?

"Currently, there are 676 T Cell-Depleted Hematopoietic Stem Cell Transplantation research trials ongoing with 106 of them in the final stage. Although Philadelphia holds a considerable number of these studies, 12096 different locations across the world host clinical research for this procedure."

Answered by AI

What conditions is T Cell-Depleted Hematopoietic Stem Cell Transplantation usually utilized for?

"T Cell-Depleted Hematopoietic Stem Cell Transplantation is a popular treatment for bladder cancer, and could also be beneficial to those suffering from meningeal leukemia, small cell lung cancer (sclc), or active pauciarticular juvenile rheumatoid arthritis."

Answered by AI

Recent research and studies

Journal of Clinical OncologyJournal

Naive T-cell Depletion to Prevent Chronic Graft-versus-host Disease

Bleakley, Marie, Alison Sehgal, Stuart Seropian, Melinda A. Biernacki, Elizabeth F. Krakow, Ann Dahlberg, Heather Persinger, et al.. 2022. “Naive T-cell Depletion to Prevent Chronic Graft-versus-host Disease”. Journal of Clinical Oncology. American Society of Clinical Oncology (ASCO). doi:10.1200/jco.21.01755.

clinicaltrials.govStudy

Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children

Marie Bleakley 2014. "Selective Depletion of CD45RA+ T Cells From Allogeneic Peripheral Blood Stem Cell Grafts in Preventing GVHD in Children". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01858740.