Health TrialsbyHealthPanel

Stem Cell Transplant From Donors After Alpha Beta Cell Depletion in Children and Young Adults

ConditionHematologic Diseases
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-60
SponsorAlice Bertaina

About this trial

The purpose of the CliniMACS® TCRαβ-Biotin System and CliniMACS® CD19 is to improve the safety and efficacy of allogeneic HLA-partially matched related or unrelated donors HSCT when no matched donors are available, to treat malignant and nonmalignant disorders for which HSCT is the recommended best available therapy. Initially this device will be used in a single-center, open-label, single-arm, phase II clinical trial to evaluate the efficacy of haploidentical PBSC grafts depleted of TCRα/β+ and CD19+ cells using the CliniMACS® TCRαβ/CD19 System in children and adults with hematological and non-hematological malignancies.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age < 60 years and > 1 month;

Life expectancy > 10 weeks;

Patients deemed eligible for allogeneic HSCT per institutional guidelines;

Patients with life-threatening hematological malignancies and non-malignant disorders that could benefit from HSCT;

Disqualifiers

Pregnant or lactating females;

Has received a prior allogenic HSCT;

Secondary MDS or AML or treatment related MDS or AML;

Dysfunction of liver (ALT/AST > 10 times upper normal value, or direct bilirubin > 3 times upper normal value),

Trial design

Design model

Parallel

Treatments tested in this trial

  • Allogeneic Stem Cell Transplant

    Biological/Vaccine

    The allogeneic stem cell transplant involves transferring the stem cells from a healthy person (donor) to the participant via infusion.

  • CliniMACS TCR α/β Reagent Kit and CliniMACS CD19

    Device

    The CliniMACS™system can be used to selectively enrich or reduce specific cell populations based on the magnetic cell selection (MACS) technology developed by Miltenyi Biotec. Cell mixtures can be separated in a magnetic field using one or more immunomagnetic- labeled antibodies specific for the cell types of interest (e.g.TCR αβ+ T cells and CD19+ B cells from HPC(A) products).

Treatment groups

204 Participants
are divided into 3 treatment groups
Group A: Stem Cell Transplant -MalignantExperimental treatment 2 interventions
Group B: Stem Cell Transplant - Non-MalignantExperimental treatment 2 interventions
Group C: Stem Cell Transplant - CompassionateOther 2 interventions

Trial outcomes

Primary outcomes

1

Number of participants with grade II-IV acute GvHD after HSCT

Time frame
Through Day 100 after HSCT

Secondary outcomes

1

Leukemia-free survival after HSCT

Leukemia-free survival defined as the time of enrollment to disease relapse or death from any cause.

Time frame
1 and 2 years after HSCT
2

Number of participants with secondary graft failure at after HSCT

Time frame
1 and 2 year after HSCT
3

Number of participants with grade III-IV acute GvHD after HSCT

Time frame
Through Day 100 after HSCT
4

Incidence rate of primary graft failure after HSCT

Time frame
Day 42 after HSCT

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Alice Bertaina

Lead sponsor

Stanford University

Sponsor institution

Source ClinicalTrials.gov
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