M-2018-334 in Hematological Malignancies

Miltenyi Biomedicine GmbH18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hematological Malignancies

Interventions

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)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * \<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 * Chronic active viral hepatitis * Cardiac dysfunction: adult patients ejection fraction \<50% on echocardiography * Patients with uncontrolled, \>grade II hypertension (per Common Toxicity Criteria, CTC) * Creatinine clearance \<60 mL/min/1.73m2 * Respiratory failure necessitating supplemental oxygen * HIV infection * Positive anti-donor HLA antibody * Treatment with checkpoint inhibitors in the period between 3 months prior to and 3 months after transplantation * Female patients who are pregnant or breast feeding, or adults of reproductive potential not willing to use an effective method of birth control during study treatment and for at least 12 months thereafter. Note: Women of childbearing potential must have a negative serum pregnancy test at study entry * Concurrent severe or uncontrolled medical disease (e.g., uncontrolled diabetes, myocardial infarction within 6 months prior to the study) which by assessment of the treating physician could compromise participation in the study * Patients with a history of psychiatric illness or a condition which could interfere with their ability to understand the requirements of the study (this includes alcoholism/drug addiction). * Patients unwilling or unable to comply with the protocol or unable to give informed consent * Treatment with any investigational product within 4 weeks prior to study treatment

Locations (1)

City of Hope

Duarte, California, United States

RECRUITING

Outcomes

Primary Outcomes

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

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)

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

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

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

Central Contacts

Clinical Trial Manager

CONTACT

+49 22048306820 clinicaltrials.gov@miltenyi.com

Data from ClinicalTrials.gov

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