Ignite Creation Date:
2024-07-17 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498973
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-05
Brief Title:
Tagraxofusp and Azacitidine for Maintenance Treatment in Patients With CD123 Positive AML and MDS Following Donor Hematopoietic Cell Transplant
Sponsor:
City of Hope Medical Center
Organization:
City of Hope Medical Center
Study Overview
Official Title:
CD123 Antibody Toxin Congregate CD123 ATC Tagraxofusp Combined With Azacitidine for Maintenance Therapy Post Allogeneic Hematopoietic Cell Transplantation for Patients With CD123-Positive Malignant
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 andor effective maintenance therapy in patients with CD123 positive AML and MDS after an allogeneic HCT
Detailed 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 3-4 acute graft-versus-host disease GVHD at 100 days post-HCT secondary graft failure and chronic GVHD at 1-year after HCT
III Estimate the cumulative incidence of infections in the first 100 days from the start of maintenance therapy
EXPLORATORY OBJECTIVES
I Describe kinetics of immune cell recovery during 1st year post-HCT and during maintenance therapy with tagraxofusp-azacitidine TAG-AZA
II Assess the possible correlation between chimerism kinetics per next generation sequencing NGS quantitative polymerase chain reaction qPCR assay and post-HCT relapse during maintenance therapy with TAG-AZA
III Characterize the presence and level of GVHD biomarkers and inflammatory cytokines in the first 100 days from the start of maintenance therapy
IV Assess patients quality of life QOL at baseline before initiation of the first cycle then at the end of cycles 3 and 6 2 weeks optional questionnaire
V Longitudinally assess CD123 expression on hematopoietic cells VI Assess changes in symptoms of chronic GVHD using Lee Symptom Scale patient self-report
VII Describe transplant outcomes defined in the secondary objectives among all consented patients regardless of receiving the study therapy
OUTLINE This is a dose-escalation study of tagraxofusp in combination with azacitidine followed by a dose-expansion study
Patients receive tagraxofusp intravenously IV over 15 minutes once daily QD on days 1-3 and azacitidine IV over 10-40 minutes QD on days 1-5 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection and bone marrow aspiration and biopsy on study
After completion of study treatment patients are followed up at 30 days and then annually for up to 2 years after start of protocol therapy
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 3-4 acute graft-versus-host disease GVHD at 100 days post-HCT secondary graft failure and chronic GVHD at 1-year after HCT
III Estimate the cumulative incidence of infections in the first 100 days from the start of maintenance therapy
EXPLORATORY OBJECTIVES
I Describe kinetics of immune cell recovery during 1st year post-HCT and during maintenance therapy with tagraxofusp-azacitidine TAG-AZA
II Assess the possible correlation between chimerism kinetics per next generation sequencing NGS quantitative polymerase chain reaction qPCR assay and post-HCT relapse during maintenance therapy with TAG-AZA
III Characterize the presence and level of GVHD biomarkers and inflammatory cytokines in the first 100 days from the start of maintenance therapy
IV Assess patients quality of life QOL at baseline before initiation of the first cycle then at the end of cycles 3 and 6 2 weeks optional questionnaire
V Longitudinally assess CD123 expression on hematopoietic cells VI Assess changes in symptoms of chronic GVHD using Lee Symptom Scale patient self-report
VII Describe transplant outcomes defined in the secondary objectives among all consented patients regardless of receiving the study therapy
OUTLINE This is a dose-escalation study of tagraxofusp in combination with azacitidine followed by a dose-expansion study
Patients receive tagraxofusp intravenously IV over 15 minutes once daily QD on days 1-3 and azacitidine IV over 10-40 minutes QD on days 1-5 of each cycle Treatment repeats every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity Patients also undergo blood sample collection and bone marrow aspiration and biopsy on study
After completion of study treatment patients are followed up at 30 days and then annually for up to 2 years after start of protocol therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-05359 | REGISTRY | None | None |
| 23400 | OTHER | None | None |
| P30CA033572 | NIH | None | None |