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T Cell Depletion

Stem Cell Transplantation for 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
Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation and have specific diagnoses including acute lymphocytic leukemia, acute myeloid leukemia, refractory anemia with excess blasts, chronic myelogenous leukemia, and other acute leukemia or related neoplasm
HLA-matched related donors >= 18 years and capable and willing to donate PBSC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is for cancer patients who need a peripheral blood stem cell transplant. The study is testing how well a selective removal of naïve T cells works in preventing GVHD after the transplant.

Who is the study for?
This trial is for patients aged 0-60 with acute lymphocytic leukemia, acute myeloid leukemia, myelodysplastic syndrome or chronic myeloid leukemia who are suitable for stem cell transplantation. They must have a matched donor and acceptable organ function. Exclusions include uncontrolled infections, severe heart/lung/kidney disease, previous certain transplants, pregnancy/breastfeeding without contraception use, other significant medical conditions or participation in conflicting trials.Check my eligibility
What is being tested?
The trial tests whether selectively removing naïve T cells from donor stem cells before transplant can prevent Graft-Versus-Host-Disease (GVHD) while preserving the benefits of fighting infections and killing residual leukemia cells. It involves high/medium intensity chemo/radiotherapy followed by infusion of modified donor blood stem cells.See study design
What are the potential side effects?
Potential side effects may include reactions to immune suppression drugs like tacrolimus and methotrexate such as increased infection risk, liver dysfunction, kidney damage; complications from chemotherapy and radiotherapy like fatigue, nausea; plus risks associated with stem cell transplantation including GVHD.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am a candidate for a stem cell transplant and have a specific type of blood cancer.
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My donor is 18 or older, matches my HLA, and agrees to donate stem cells.
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I have a donor match willing to donate stem cells.
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I have a donor who matches my HLA type for a stem cell donation.

Timeline

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
Occurrence of chronic graft-versus-host disease (GHVD), defined operationally as the occurrence of compatible symptoms meeting National Institutes of Health criteria and requiring systemic pharmacological immunosuppression
Presence of acute graft-versus-host disease (GVHD) grades II-IV
+5 more
Secondary outcome measures
Chimerism analysis
Relapse
Time to absolute neutrophil count (ANC) of > 1,000/uL on the first of three consecutive test results
+4 more

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478
23%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

4Treatment groups
Experimental Treatment
Group I: Arm D (MUD)Experimental Treatment8 Interventions
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
Group II: Arm C (MUD)Experimental Treatment9 Interventions
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with G-CSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. Patients also receive methotrexate IV on days 1, 3, 6, and 11.
Group III: Arm B (MRD)Experimental Treatment9 Interventions
LOWER-INTENSITY MYELOABLATIVE CONDITIONING: Patients receive cyclophosphamide IV over 1 hour on day -6, fludarabine phosphate IV over 30 minutes on days -6 to -2, and thiotepa IV over 4 hours on days -5 and -4. Patients also undergo total body irradiation QD on days -2 and -1. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days and mycophenolate mofetil IV and PO every 8 hours on day -3 to approximately day 30, with or without taper at the discretion of the treating physician. Mycophenolate mofetil should be continued or resumed after day 30 if donor chimerism is low, after discussion with the Principal Investigator.
Group IV: Arm A (MRD)Experimental Treatment9 Interventions
HIGH-INTENSITY MYELOABLATIVE CONDITIONING: Patients undergo total body irradiation BID on days -10 to -7. Patients also receive thiotepa IV over 4 hours on days -6 and -5 and fludarabine phosphate IV over 30 minutes on days -6 to -2. TRANSPLANT: In all arms, patients undergo allogeneic HSCT with GCSF-mobilized CD34-enriched PBSC and CD45RA-depleted cells on day 0. GVHD PROPHYLAXIS: Beginning day -1, patients receive tacrolimus IV over 22-24 hours or PO (BID if given PO) for 50 days with taper in the absence of GVHD. 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
Thiotepa
2008
Completed Phase 3
~2150
Allogeneic Hematopoietic Stem Cell Transplantation
2012
Completed Phase 2
~1200
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Cyclophosphamide
1995
Completed Phase 3
~3780
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Total-Body Irradiation
1997
Completed Phase 3
~1180
Tacrolimus
2011
Completed Phase 4
~4740
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330

Find a Location

Who is running the clinical trial?

Fred Hutchinson Cancer Research CenterLead Sponsor
443 Previous Clinical Trials
148,297 Total Patients Enrolled
Fred Hutchinson Cancer CenterLead Sponsor
555 Previous Clinical Trials
1,334,642 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,609 Previous Clinical Trials
40,915,562 Total Patients Enrolled

Media Library

Selective Depletion of CD45RA+ T Cells (T Cell Depletion) Clinical Trial Eligibility Overview. Trial Name: NCT02220985 — Phase 2
Hematopoietic Stem Cell Transplant Recipient Research Study Groups: Arm D (MUD), Arm B (MRD), Arm A (MRD), Arm C (MUD)
Hematopoietic Stem Cell Transplant Recipient Clinical Trial 2023: Selective Depletion of CD45RA+ T Cells Highlights & Side Effects. Trial Name: NCT02220985 — Phase 2
Selective Depletion of CD45RA+ T Cells (T Cell Depletion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02220985 — Phase 2

Frequently Asked Questions

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

Are there any other case studies concerning Peripheral Blood Stem Cell Transplantation that have been reported?

"City of Hope Comprehensive Cancer Center was the first to conduct research into Peripheral Blood Stem Cell Transplantation in 1997. As of now, 2783 clinical trials have been completed, with 1129 actively being conducted across various sites - particularly Pittsburgh Pennsylvania."

Answered by AI

In what instances has Peripheral Blood Stem Cell Transplantation been found to be beneficial?

"Peripheral Blood Stem Cell Transplantation is a common treatment option for small cell lung cancer (SCLC) and can often be effective in addressing certain forms of dermatitis, atopy, acute leukemia, multiple sclerosis and many other conditions."

Answered by AI

How many individuals is the trial accepting at this time?

"Unfortunately, this clinical study is no longer open for recruitment. It was first posted on February 3rd 2015 and the latest update was made June 28th 2022. For those searching for other trials, there are currently 3776 studies admitting patients with acute biphenotypic leukemia and 1129 studies looking to recruit participants for Peripheral Blood Stem Cell Transplantation."

Answered by AI

What potential risks should be considered regarding Peripheral Blood Stem Cell Transplantation?

"Peripheral Blood Stem Cell Transplantation has been assessed as a 2 on our safety scale, due to existing data demonstrating its safety but an absence of evidence in support of efficacy."

Answered by AI

Are there remaining opportunities for potential participants to join this experiment?

"Confirmed. As reported on clinicaltrials.gov, this research study is not presently recruiting participants despite having been posted in February 2015 and updated as recently as June 28th 2022. Alternatively, 4,905 other medical trials are actively seeking volunteers at the present time."

Answered by AI
~8 spots leftby Apr 2025