CD123 Antibody Toxin Congregate (CD123 ATC; Tagraxofusp) Combined With Azacitidine for Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for Patients With CD123-Positive Malignant
City of Hope Medical Center
Summary
This phase Ib trial tests the safety, side effects, best dose and effectiveness of tagraxofusp in combination with azacitidine as maintenance therapy in treating patients with CD123 positive acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS) after a donor (allogeneic) hematopoietic cell transplant. An allogeneic hematopoietic cell transplant (HCT) is a type of transplant where the cancer patient receives cells from another person. Maintenance therapy is given after the transplant to prevent the cancer from coming back. Tagraxofusp is a drug that targets cells that have CD123 on their surface in order to kill the cancer cells to help prevent the cancer from coming back. Azacitidine is in a class of medications called demethylation agents. It works by helping the bone marrow to produce normal blood cells and by killing abnormal cells. Giving tagraxofusp in combination with azacitidine may be safe, tolerable and/or effective maintenance therapy in patients with CD123 positive AML and MDS after an allogeneic HCT.
Description
PRIMARY OBJECTIVE: I. Evaluate the safety and feasibility of tagraxofusp-erzs (tagraxofusp) with a fixed dose of azacitidine and determine the recommended phase 2 dose (RP2D) for tagraxofusp in patients with CD123-positive hematological malignancy when given as maintenance therapy following allogeneic transplant (HCT). SECONDARY OBJECTIVES: I. Estimate overall survival (OS), progression-free survival (PFS) and the cumulative incidence of relapse and non-relapse mortality (NRM) at 100 days and 1 year after starting maintenance therapy. II. Evaluate the cumulative incidence of grade 2-4 and…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Documented informed consent of the participant and/or legally authorized representative * Agreement to allow the use of archival tissue from diagnostic tumor biopsies. * If unavailable, exceptions may be granted with study principal investigator (PI) approval * Age: 18-75 years old * Eastern Cooperative Oncology Group (ECOG) ≤ 2 * First or second allogeneic HCT-eligible patients with AML or MDS with high-risk cytogenetics per European LeukemiaNet (ELN) (AML) or Revised International Prognostic Scoring System (R-IPSS) (MDS); or by having active (morphological) or minim…
Interventions
- DrugAzacitidine
Given IV
- ProcedureBiospecimen Collection
Undergo blood sample collection
- ProcedureBone Marrow Aspiration
Undergo bone marrow aspiration and biopsy
- ProcedureBone Marrow Biopsy
Undergo bone marrow aspiration and biopsy
- OtherQuestionnaire Administration
Ancillary studies
- BiologicalTagraxofusp-erzs
Given IV
Location
- City of Hope Medical CenterDuarte, California