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T-Cell Depletion

CD34-Selected Stem Cell Transplant for Bone Marrow Transplant (EXCESS Trial)

N/A
Recruiting
Led By Robert Krance, MD
Research Sponsored by Baylor College of Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Evidence of poor bone marrow function (bone marrow cellularity less than 50% with at least one cytopenia)
Relapsed or persistent disease
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

EXCESS Trial Summary

This trial is for people with a disease that requires a stem cell transplant, but don't have a perfect match. A close relative has been identified whose stem cells are not a perfect match, but can be used. The donor's blood cells are treated to minimize cells that are most likely to attack the patient's tissues.

Who is the study for?
This trial is for patients needing a stem cell transplant who don't have a perfect match donor. It's open to individuals from birth to 70 years old, with mixed chimerism or poor bone marrow function after an initial transplant, or those requiring additional cellular therapy due to relapsed disease.Check my eligibility
What is being tested?
The CliniMACS CD34 Reagent System is being tested. This system treats the donor's blood cells before transplantation in order to reduce graft-versus-host disease (GvHD) by isolating 'good' stem cells and minimizing T cells that could attack the patient's body.See study design
What are the potential side effects?
Potential side effects may include reactions related to the immune system as it integrates new stem cells, such as mild forms of GvHD despite treatment, infection risks due to weakened immunity during engraftment, and possible infusion-related reactions.

EXCESS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My bone marrow is not functioning well.
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My condition has come back or hasn't improved.
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I can understand and sign the consent form myself or have someone who can.
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I am 70 years old or younger.
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I can understand and sign the consent form myself or have someone who can do it for me.
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I received a stem cell transplant from a donor and need more cell therapy.
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I am eligible for a CD34+ topoff.
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I need a stem cell transplant from a donor.
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I am younger than 70 years old.

EXCESS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
For Cohort 1: the rate of primary engraftment 50 days post SCT
Secondary outcome measures
Assessment of Long Term Survival
For Both Cohorts: The total incidence of overall acute GvHD (greater than or equal to grade 3)

EXCESS Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2: CD34+ cells as a top offExperimental Treatment1 Intervention
Cohort 2 consists of patients needing additional CD34+ stem cells collected by 'CliniMACS CD34 Reagent system' as a "topoff" without the need for additional conditioning prior to the infusion. These patients who have already received SCT and are receiving CD34+ cells from their original donor for poor graft function, declining chimerism or disease relapse.
Group II: Cohort 1: CD34+ Cells for transplantExperimental Treatment1 Intervention
Cohort 1 consists of patients receiving CD34+ selected peripheral blood stem cell transplant with a preceding conditioning regimen (chemotherapy with, or without, radiation). The stem cells will then be separated out from the white blood cells by a special machine- called a CliniMACS CD34 Reagent System in the laboratory.

Find a Location

Who is running the clinical trial?

Baylor College of MedicineLead Sponsor
999 Previous Clinical Trials
6,001,753 Total Patients Enrolled
Center for Cell and Gene Therapy, Baylor College of MedicineOTHER
111 Previous Clinical Trials
2,673 Total Patients Enrolled
The Methodist Hospital Research InstituteOTHER
270 Previous Clinical Trials
80,104 Total Patients Enrolled

Media Library

CliniMACS CD34 Reagent system (T-Cell Depletion) Clinical Trial Eligibility Overview. Trial Name: NCT01189786 — N/A
Bone Marrow Transplant Research Study Groups: Cohort 1: CD34+ Cells for transplant, Cohort 2: CD34+ cells as a top off
Bone Marrow Transplant Clinical Trial 2023: CliniMACS CD34 Reagent system Highlights & Side Effects. Trial Name: NCT01189786 — N/A
CliniMACS CD34 Reagent system (T-Cell Depletion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01189786 — N/A

Frequently Asked Questions

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

Is this investigation currently enrolling participants?

"Indeed, the information on clinicaltrials.gov affirms that this medical trial is actively recruiting participants. Initially posted on October 1st 2010 and last updated January 5th 2022, 144 patients need to be recruited at two separate sites."

Answered by AI

To what extent is this medical study being populated by participants?

"Affirmative. Clinicaltrials.gov lists this medical trial as actively seeking participants since its first posting on October 1st, 2010 and last update on January 5th 2022. 144 individuals must be sourced from two different locations for successful completion of the study."

Answered by AI
~14 spots leftby Oct 2025