Gene-edited donor stem cell transplant with gemtuzumab for relapsed leukemia
Tests gene-edited donor stem cells with gemtuzumab in adults with relapsed acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: Genetic Ablation of CD33 in HSC to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with AML
Key facts
- Where
- Dresden and Heidelberg, GermanySee the 2 sites
- Phase
- Phase 1
Where in Germany
- University Hospital Dresden, Department of Medicine IDresden, GermanyNo longer taking part
- University Hospital Heidelberg, Internal Medicine VHeidelberg, GermanyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- German Cancer Research Center
- Trial code
- NCT05662904
- Record updated
- 14 March 2025
- Original description
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.Read full original descriptionShow less
Genetic Ablation of CD33 in Hematopoietic Stem Cells to Broaden the Therapeutic Index of CD33-directed Immunotherapy in Patients with Acute Myeloid Leukemia (AML)
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.
Inclusion: 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; confirmed CD33 expression on leukemic blasts at current relapse (as detected by flow cytometry); adequate organ function:; Renal function defined as: serum creatinine of ≤ 2x ULN or eGFR ≥ 30 mL/min/1.73 m2; Liver function defined as:; ALT ≤ 3 times the ULN for the respective age; Bilirubin ≤ 2.0 mg/dl with the exception of patients with hyperbilirubinemia explained by Gilbert-Meulengracht syndrome (may be included if total bilirubin is ≤ 3.0 x ULN and direct bilirubin ≤ 1.5 x ULN) or extrahepatic disease (e.g. chronic hemolytic anemia); Minimum level of pulmonary reserve defined as ≤ grade 1 dyspnea and pulse oxygenation > 90% on room air; Hemodynamic stability and LVEF ≥ 40% as confirmed by echocardiogram; Absolute lymphocyte count (ALC) ≥ 100/mm3.
Exclusion: Prior treatment with GO; Prior hepatic veno-occlusive disease (VOD) or sinusoidal obstruction syndrome (SOS); Severe concomitant disease (e.g. uncontrolled arterial hypertension, heart failure NYHA III-IV, uncontrolled diabetes mellitus, uncontrolled hyperlipidemia); Unstable angina and/or myocardial infarction within 3 months prior to screening; Acute or chronic Graft versus Host disease (GvHD); Uncontrolled active hepatitis B or C; HIV-positivity; Uncontrolled bacterial, viral or fungal infection; Organ dysfunction (liver, kidney, lung, heart) that is a contraindication for conditioning therapy; ECOG performance status >2; Confirmed CNS involvement; Availability of other curative standard treatment options; Participation in another clinical trial at the time of screening; Pregnant or nursing (lactating) women.