Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523556
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-09
Brief Title:
Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms Myeloproliferative NeoplasmMyelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Phase 1b2 Study of Axatilimab SNDX-6352 Azacitidine AZA in Advanced Phase MPN MPNMDS Overlap or High-Risk CMML
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase IbII trial tests the best dose of axatilimab and effectiveness of axatilimab with or without azacitidine for the treatment of patients with advanced phase myeloproliferative neoplasms MPN myeloproliferative neoplasmmyelodysplastic syndrome MPNMDS overlap or high risk chronic myelomonocytic leukemia CMML Axatilimab is an antibody that is cloned from a single white blood cell that is known to be able to recognize cancer cells and block a protein on the surface of the white blood cells that may be involved in cancer cell growth By blocking the proteins this may slow or halt the growth of the cancer Azacitidine is in a class of medications called antimetabolites It works by stopping or slowing the growth of cancer cells Giving axatilimab with or without azacitidine may be safe and effective in treating patients with advanced phase MPN MPNMDS overlap or high risk CMML
Detailed Description:
PRIMARY OBJECTIVES
I To determine the recommended phase 2 dose RP2D of axatilimab in relapsed or refractory patients with advanced phase MPN MPNMDS overlap or high-risk CMML
II To evaluate the overall response rate of axatilimab azacitidine AZA in newly diagnosed patients with advanced phase MPN MPNMDS overlap or high-risk CMML using Savona response criteria
SECONDARY OBJECTIVES
I Determine the safety and tolerability of axatilimab azacitidine combination therapy in those with newly diagnosed advanced phase MPN MPNMDS overlap or high-risk CMML
II Determine the quality of life in patients receiving axatilimab AZA using a Modified Myeloproliferative Neoplasm Symptom Assessment Form MPNSAF
III Determine the effect of axatilimab azacitidine on symptom relief which will be measured by transfusion burden platelet andor packed red blood cell time in hospital and immune related side effects specifically reactivation of tuberculosis TB infusion-related reactions hepatotoxicity pneumonia pyrexia sepsis shortness of breath SBO hemoptysis periorbital edema fatigue and pancreatitis
EXPLORATORY OBJECTIVES
I To assess the pharmacokinetics of axatilimab in combination with AZA II To describe the prevalence and trajectories of patients physical activity during treatment
III To perform detailed correlative studies related to genetic biochemical and immunologic changes that occur with axatilimab in combination with AZA
OUTLINE This is a phase I dose-escalation study of axatilimab followed by a phase II study
PHASE I Patients receive axatilimab intravenously IV over 30 minutes on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity At time of phase Ib completion patients with clinical improvement may transition to phase II Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study
PHASE II Patients receive axatilimab IV over 30 minutes on days 1 and 15 and azacitidine IV over 10-40 minutes or subcutaneously SC on days 1-7 of each cycle Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients who achieve partial response PR or better may continue for up to 24 total cycles Patients who achieve less than PR receive 2 additional cycles and if PR or better is achieved may complete up to 24 total cycles Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days and then every 6 months for up to 24 months after last dose of study medication
I To determine the recommended phase 2 dose RP2D of axatilimab in relapsed or refractory patients with advanced phase MPN MPNMDS overlap or high-risk CMML
II To evaluate the overall response rate of axatilimab azacitidine AZA in newly diagnosed patients with advanced phase MPN MPNMDS overlap or high-risk CMML using Savona response criteria
SECONDARY OBJECTIVES
I Determine the safety and tolerability of axatilimab azacitidine combination therapy in those with newly diagnosed advanced phase MPN MPNMDS overlap or high-risk CMML
II Determine the quality of life in patients receiving axatilimab AZA using a Modified Myeloproliferative Neoplasm Symptom Assessment Form MPNSAF
III Determine the effect of axatilimab azacitidine on symptom relief which will be measured by transfusion burden platelet andor packed red blood cell time in hospital and immune related side effects specifically reactivation of tuberculosis TB infusion-related reactions hepatotoxicity pneumonia pyrexia sepsis shortness of breath SBO hemoptysis periorbital edema fatigue and pancreatitis
EXPLORATORY OBJECTIVES
I To assess the pharmacokinetics of axatilimab in combination with AZA II To describe the prevalence and trajectories of patients physical activity during treatment
III To perform detailed correlative studies related to genetic biochemical and immunologic changes that occur with axatilimab in combination with AZA
OUTLINE This is a phase I dose-escalation study of axatilimab followed by a phase II study
PHASE I Patients receive axatilimab intravenously IV over 30 minutes on days 1 and 15 of each cycle Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity At time of phase Ib completion patients with clinical improvement may transition to phase II Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study
PHASE II Patients receive axatilimab IV over 30 minutes on days 1 and 15 and azacitidine IV over 10-40 minutes or subcutaneously SC on days 1-7 of each cycle Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity Patients who achieve partial response PR or better may continue for up to 24 total cycles Patients who achieve less than PR receive 2 additional cycles and if PR or better is achieved may complete up to 24 total cycles Patients undergo bone marrow biopsy and aspiration and blood sample collection throughout the study
After completion of study treatment patients are followed up at 30 days and then every 6 months for up to 24 months after last dose of study medication
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None