RECRUITING

Axatilimab With or Without Azacitidine for the Treatment of Patients With Advanced Phase Myeloproliferative Neoplasms, Myeloproliferative Neoplasm/Myelodysplastic Syndrome Overlap or High Risk Chronic Myelomonocytic Leukemia

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Conditions

Atypical Chronic Myeloid LeukemiaChronic Myelomonocytic LeukemiaMyelodysplastic/Myeloproliferative NeoplasmRecurrent Myelodysplastic/Myeloproliferative NeoplasmRecurrent Myeloproliferative NeoplasmRefractory Chronic Myelomonocytic LeukemiaRefractory Myelodysplastic/Myeloproliferative NeoplasmRefractory Myeloproliferative Neoplasm

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase Ib/II 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 neoplasm/myelodysplastic syndrome (MPN/MDS) 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, MPN/MDS overlap or high risk CMML.

Official Title

Phase 1b/2 Study of Axatilimab (SNDX-6352) + Azacitidine (AZA) in Advanced Phase MPN, MPN/MDS Overlap or High-Risk CMML

Quick Facts

Study Start:2024-08-02
Study Completion:2026-12-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06523556

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Signed informed consent must be obtained prior to participation in the study
  2. * Age ≥ 18 years at the date of signing the informed consent form (ICF)
  3. * Morphologically confirmed diagnosis of the following based on 2016 World Health Organization (WHO) classification (Arber et al 2016): Phase 1b, patients with relapsed or refractory of any of the following; phase 2, patients with newly diagnosed of any of the following:
  4. * Chronic myelomonocytic leukemia (CMML), classified as intermediate-2, OR high-risk per the CMML Specific Prognostic Scoring System (CPSS) Molecular Model
  5. * Atypical chronic myelocytic leukemia (aCML)
  6. * MDS/MPN unclassified (MDS/MPN-U)
  7. * Myeloproliferative neoplasm accelerated phase (MPN-AP)
  8. * MPN-AP requires a previous diagnosis of polycythemia vera (PV), essential thrombocythemia (ET), or primary myelofibrosis (PMF) with intermediate-2 or high risk disease according to International Prostate Symptom Score (IPSS) as well as progression on or failure to respond to at least one line of therapy.
  9. * Myelodysplastic syndrome/myeloproliferative neoplasm with ring sideroblasts and thrombocytosis (MDS/MPN-RS-T) or MDS/MPN with SF3B1 mutation and thrombocytosis (MDS/MPN-SF3B1-T).
  10. * Not suitable for immediate myeloablative/intensive chemotherapy based on investigator assessment of age, comorbidities, local guidelines, institutional practice (any or all of these)
  11. * Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
  12. * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN)
  13. * Total bilirubin ≤ 1.5 × ULN (except in the setting of isolated Gilbert syndrome)
  14. * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 (estimation based on Modification of Diet in Renal Disease \[MDRD\] formula, by local laboratory)
  15. * Patient is able to communicate with the investigator and has the ability to comply with the requirements of the study procedures
  16. * Women of childbearing potential and men, if not surgically sterilized, should use adequate contraception from 14 days prior to study entry and until 90 days after the last follow-up visit. Adequate contraception is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm or cervical cap, or a condom
  1. * Previous treatment for MPN or MDS/MPN overlap with chemotherapy or other antineoplastic agents including lenalidomide and hypomethylating agent (HMAs) such as decitabine or azacitidine or INQOVI (oral decitabine) (patients who had up to 2 cycles of hypomethylating agents \[HMAs\] can be included). However, previous treatment with hydroxyurea and/or ruxolitinib is permitted
  2. * Diagnosis of acute myeloid leukemia (AML) including acute promyelocytic leukemia and extra-medullary AML based on WHO 2016 classification (Arber et al 2016)
  3. * Patients who are candidates for myeloablative or intensive chemotherapy treatment or who do not provide consent for this treatment
  4. * History of organ transplant or allogenic hematopoietic stem cell transplant
  5. * Participants with prior malignancy, except:
  6. * Participants with history of adequately treated malignancy for which no anticancer systemic therapy (namely chemotherapy, radiotherapy or surgery) is ongoing or required during the course of the study.
  7. * Participants who are receiving adjuvant therapy such as hormone therapy are eligible. However, participants who developed therapy related neoplasms are not eligible
  8. * Previous known allergy/sensitivity to components of axatilimab
  9. * History of acute or chronic pancreatitis
  10. * History of myositis

Contacts and Locations

Study Contact

The Ohio State University Comprehensive Cancer Center
CONTACT
800-293-5066
OSUCCCClinicaltrials@osumc.edu

Principal Investigator

Uma M Borate, MD
PRINCIPAL_INVESTIGATOR
Ohio State University Comprehensive Cancer Center

Study Locations (Sites)

Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: Uma Borate

  • Uma M Borate, MD, PRINCIPAL_INVESTIGATOR, Ohio State University Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-08-02
Study Completion Date2026-12-31

Study Record Updates

Study Start Date2024-08-02
Study Completion Date2026-12-31

Terms related to this study

Additional Relevant MeSH Terms

  • Atypical Chronic Myeloid Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myelodysplastic/Myeloproliferative Neoplasm
  • Recurrent Myelodysplastic/Myeloproliferative Neoplasm
  • Recurrent Myeloproliferative Neoplasm
  • Refractory Chronic Myelomonocytic Leukemia
  • Refractory Myelodysplastic/Myeloproliferative Neoplasm
  • Refractory Myeloproliferative Neoplasm