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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

No Placebo-Only Group

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.

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.

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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I am younger than 23 years old.

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My condition is currently in remission.

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I have acute lymphoblastic leukemia.

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I have been diagnosed with myelodysplasia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

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

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

Primary study objectives

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 study objectives

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.