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Cell Depletion

Stem Cell Selection for Blood Diseases

Phase 2

Recruiting

Research Sponsored by Mitchell Cairo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6. Sickle Cell Disease (Homozygous Hemoglobin S Disease, or Hemoglobin S β 0/+ thalassemia, or Hemoglobin SC Disease)

High Risk Myelodysplastic syndrome (MDS)

Must not have

Patients with documented uncontrolled infection at the time of study entry are not eligible.

Females who are pregnant or breast-feeding are not eligible.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

No Placebo-Only Group

All Individual Drugs Already Approved

Summary

This trial is testing a new stem cell selection method for children, adolescents, and young adults undergoing an AlloSCT. The new method uses α/β CD3+/CD19+ cell depletion to select the stem cells, and all other treatment is standard of care.

Who is the study for?

This trial is for children and young adults (0-30 years) with various blood diseases, including high-risk acute leukemia, lymphoma, sickle cell disease, and bone marrow failure syndromes. Participants must have adequate organ function and not be pregnant or breastfeeding. They can't join if they've had a recent transplant or uncontrolled infection.

What is being tested?

The study tests a stem cell transplantation technique using α/β CD3+/CD19+ cell depletion in patients with malignant and non-malignant hematologic conditions. This method aims to improve outcomes by selecting specific cells while maintaining standard care treatments.

What are the potential side effects?

While the description doesn't specify side effects of α/β T-cell depletion, similar procedures may include risks like infections due to lowered immunity, graft-versus-host disease where donor cells attack the body, bleeding complications from low platelet count, and reactions to infusion.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have Sickle Cell Disease.

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I have been diagnosed with high-risk Myelodysplastic syndrome.

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I have a bone marrow failure syndrome and treatments haven't worked for me.

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I am 30 years old or younger.

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I have AML and it has not responded well to initial treatments or it has come back.

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My leukemia is considered high risk due to specific genetic features or because it didn't respond well to initial treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have any untreated infections.

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I am not pregnant or breastfeeding.

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I need assistance with my daily activities due to my health condition.

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My graft-versus-host disease is mild.

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

incidence of adverse events related to administration of α/β CD3+/CD19+ cell depleted stem cells

Secondary study objectives

incidence of GVHD following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion

incidence of hematpoitic engraftment following Allogeneic stem cell transplantation (AlloSCT) utilizing α/β CD3+/CD19+ cell depletion

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

1Treatment groups

Experimental Treatment

Group I: alpha beta cell depletionExperimental Treatment1 Intervention

Matched allogeneic donor stem cells will be processed utilizing α/β CD3+/CD19+ cell depletion with the Prodigy system. Standard pre-conditioning and post-transplant motioning will be given.

0 / 10Eligibility criteria met