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Cell Depletion

Stem Cell Transplant for Blood Cancer

Phase 2 & 3
Waitlist Available
Led By Julie-An Talano, MD
Research Sponsored by Julie-An M. Talano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age. Patient age < 23 years. Both genders and all races eligible.
Acute myeloid leukemia, primary or secondary
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

Study Summary

This trial is testing a new stem cell transplant method for people with blood cancer who don't have a perfect match for a donor. They will be observed for one year to see how well they engraft and don't get leukemia again.

Who is the study for?
This trial is for patients under 23 years old with various blood cancers, including lymphoma and leukemia, who are in remission or have less than 10% bone marrow blasts. It's open to all genders and races but excludes those without a suitable donor or who don't meet specific disease, organ function, or infection criteria.Check my eligibility
What is being tested?
The study tests the CliniMACS device's ability to deplete Alpha Beta T cells plus CD19+ B cells from stem cell transplants in patients with blood cancers using alternative donors. The goal is to see how well it works by looking at engraftment success, avoidance of GVHD (graft-versus-host disease), and one-year survival without leukemia.See study design
What are the potential side effects?
Potential side effects may include complications related to stem cell transplantation such as infections due to immune system suppression, graft failure, GVHD where the new cells attack the patient’s body, and reactions related to infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am younger than 23 years old.
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My condition is acute myeloid leukemia.
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My condition is in a specific phase of chronic illness.
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My cancer is in remission or my bone marrow has less than 10% cancer cells.
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My leukemia is of a mixed or dual type.
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My condition is currently in remission.
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I have been diagnosed with Burkitt's lymphoma or leukemia.
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My blood cancer is currently in remission.
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I have been diagnosed with lymphoblastic lymphoma.
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My leukemia is of a mixed or dual type.
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I am younger than 23 years old.
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I have acute myeloid leukemia, either primary or secondary.
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I have been diagnosed with lymphoblastic lymphoma.
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I have acute lymphoblastic leukemia.
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My condition is currently in remission.
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I have acute lymphoblastic leukemia.
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My blood cancer is currently in remission.
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My cancer is in remission or has minimal presence in my bone marrow.
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My condition is in a specific phase of chronic illness.
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I have been diagnosed with myelodysplasia.
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I have been diagnosed with myelodysplasia.
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My condition qualifies for this 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
Evaluate the engraftment of patients receiving unrelated donor or partially matched related donor peripheral stem cells that have T cell depleted and CD19+ B cell depleted using the CliniMACS device.
Secondary outcome measures
Assess the incidence treatment-related mortality (TRM).
Assess the probability of one year leukemia free survival (LFS).
Estimate the incidence and extent of acute and chronic graft vs. host disease.

Side effects data

From 2017 Phase 2 trial • 93 Patients • NCT00579124
7%
Non-relapsed mortality
100%
80%
60%
40%
20%
0%
Study treatment Arm
AEs for Total Number of Participants: Stratum 1
AEs for Total Number of Participants: Stratum 2

Trial Design

1Treatment groups
Experimental Treatment
Group I: Single Experimental ArmExperimental Treatment1 Intervention
Alpha Beta T cell depletion is performed for all PBSC grafts using the CliniMACs device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CliniMACs
2005
Completed Phase 2
~100

Find a Location

Who is running the clinical trial?

Miltenyi Biotec, Inc.Industry Sponsor
9 Previous Clinical Trials
214 Total Patients Enrolled
Julie-An M. TalanoLead Sponsor
Julie-An Talano, MDPrincipal InvestigatorMedical College of Wisconsin
2 Previous Clinical Trials
49 Total Patients Enrolled

Media Library

CliniMACS (Cell Depletion) Clinical Trial Eligibility Overview. Trial Name: NCT02600208 — Phase 2 & 3
Blood Cancers Research Study Groups: Single Experimental Arm
Blood Cancers Clinical Trial 2023: CliniMACS Highlights & Side Effects. Trial Name: NCT02600208 — Phase 2 & 3
CliniMACS (Cell Depletion) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02600208 — Phase 2 & 3

Frequently Asked Questions

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

Are people currently being sought out for this experiment?

"No, this particular clinical trial is not currently recruiting patients. Although, it is worth mentioning that there are 2613 other trials actively looking for participants. This specific study was posted on October 1st, 2015 and updated for the last time on April 4th, 2022."

Answered by AI
~14 spots leftby Dec 2026