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M-2018-334 in Hematological Malignancies

ConditionHematological Malignancies
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMiltenyi Biomedicine GmbH

About this trial

This is a single-center, open-label, single-arm, pilot clinical study using TCRα/β and CD45RA depleted stem cell grafts from haploidentical donors for hematopoietic cell transplantation in 12 to 18 adult patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients, between 18 years to 75 years of age, with high-risk hematological malignancy requiring an allogeneic hematopoietic stem cell transplantation (AlloHCT), but do not have an HLA-matched donor available

Disqualifiers

<3 months after preceding autologous transplantation or prior AlloHCT

History of neurological impairment (active seizures, severe peripheral neuropathy, signs of leukoencephalopathy, active CNS infection)

Active fungal infections with radiological and clinical progression

Liver function abnormalities with bilirubin >2 mg/dL and elevation of transaminases higher than 400 U/L

Trial design

Design model

Single group

Treatments tested in this trial

  • CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)

    Device

    PBSC grafts from haploidentical donors depleted of TCRaβ+ cells and CD45RA+ cells using CliniMACS Prodigy® will be infused into patients intravenously (IV)

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: HSC RecipientExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of severe acute GVHD (aGVHD) till Day 100

Participants will be evaluated for the occurrence of aGVHD, grades III-IV in the first 100 days after transplantation and the time to occurrence of aGVHD, grades III-IV will be recorded. Severity of acute GVHD will be graded according to the CONSENSUS CRITERIA FOR GRADING OF ACUTE GVHD which has four Grades from Grade I to Grade IV. The higher the Score, the Worse the outcome.

Time frame
100 days after haploidentical hematopoietic cell transplantation

Secondary outcomes

1

Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA(Trial Version)

Performance of the CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version) will be assessed by calculating the log-depletion of TCRα/β+ and CD45RA+ cells

Time frame
Until Last Patient Last Visit(24 Months)
2

Incidence of acute GVHD (aGVHD) till six months post-transplantation

Incidence of aGVHD, grade II-IV till six months post-transplantation will be evaluated. The maximum grade and the time to occurrence of acute GVHD will be recorded. Incidence and severity of acute GVHD will be graded according to the Consensus Criteria

Time frame
6 Months
3

Neutrophil Engraftment

Time to neutrophil engraftment will be defined as the first of three consecutive measurements of ANC ≥500/µL following conditioning regimen induced nadir, starting from the day of the first stem cell transplantation

Time frame
Day 7
4

Platelet Engraftment

Time to platelet engraftment will be defined as the first of three consecutive measurements of platelet count ≥20,000/µL without platelet transfusion support, starting from the day of the first stem cell transplantation.

Time frame
Day 0

Other outcomes

Sponsors and contacts

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

Miltenyi Biomedicine GmbH

Lead sponsor

City of Hope Medical Center

Collaborator

Source ClinicalTrials.gov
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