About this trial
The study "GALAXY33" is an open-label, prospective, nonrandomized, one arm phase I clinical trial in which patients with relapsed AML after allogeneic hematopoietic stem cell transplantation will be transplanted with CD33-deleted CD34+ HSC derived from the initially matched family donor.
Eligibility criteria
Qualifiers
confirmed AML according to the WHO classification
relapsed disease after allo-SCT from an HLA-identical family donor (≥ 2 months after allo-SCT at time of inclusion)
≤ 29% of bone marrow blasts as detected by cytomorphology or immunohistochemistry
age ≥ 18 years
Disqualifiers
ECOG performance status >2
Confirmed CNS involvement
Acute or chronic Graft versus Host disease (GvHD)
Availability of other curative standard treatment options
Trial design
Treatments tested in this trial
- Donor-derived CD34+ HSC with CRISPR/Cas9-mediated CD33 deletion
- Gemtuzumab Ozogamicin
Treatment groups
Sponsors and collaborators
German Cancer Research Center
Lead sponsor
University Hospital Heidelberg
Collaborator
University Hospital Dresden
Collaborator