M-2018-334 in Hematological Malignancies
ConditionHematological Malignancies
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- CliniMACS Prodigy® LP-TCRα/β-19-45RA (Trial Version)
Treatment groups
18 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Miltenyi Biomedicine GmbH
Lead sponsor
City of Hope Medical Center
Collaborator
Source ClinicalTrials.gov