Canakinumab and Azacitidine for the Treatment of Low or Intermediate Risk Myelodysplastic Syndrome and Chronic Myelomonocytic Leukemia

• Status: Not yet recruiting
• Trial end date: 2022-01-31
• Target enrollment: 60
• Participant gender: All

Summary

This phase II trial studies how well canakinumab and azacitidine work for the treatment of low- or intermediate-risk myelodysplastic syndrome or chronic myelomonocytic leukemia. Immunotherapy with canakinumab, may induce changes in body's immune system and may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as azacitidine works in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving canakinumab and azacitidine may work better in controlling the disease.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Antibodies, Monoclonal; Azacitidine

Criteria

Inclusion Criteria:

• Diagnosis of MDS or CMML according to World Health Organization (WHO) and low or intermediate-1 risk by

International Prognostic Scoring System (IPSS) or revised International Prognostic Scoring System (IPSS-R) with a score of =< 3.5 and:

• Previously untreated and with white blood cells (WBC) < 12 X 10 k/ul for patients with CMML (dysplastic CMML)

• Previously treated. Patients need to have relapsed or progressed after prior therapy with erythropoietin stimulating agents (ESAs), lenalidomide if del(5q) MDS or no response after at least 4 cycles of decitabine or 6 cycles of hypomethylating agent-based therapy, or relapse or progression after any number of cycles

• Hemoglobin < 10 g/dL or transfusion dependency defined as the need for prior transfusion in the past 8 weeks

• Patient (or patient's legally authorized representative) must have signed an informed consent document indicating that the patient understands the purpose of and procedures required for the study and is willing to participate in the study

• Total bilirubin 3 X upper limit of normal (ULN)

• Aspartate transaminase (AST) or alanine transferase (ALT) =< 3 X ULN

• Serum creatinine clearance > 30mL/min and no end/stage renal disease (using Cockcroft-Gault)

• Eastern Cooperative Oncology Group (ECOG) performance status =< 2

• Hydroxyurea for control of leukocytosis is allowed at any time prior to or during study if considered to be in the best interest of the patient

Exclusion Criteria:

• Uncontrolled infection not adequately responding to appropriate antibiotics

• Absolute neutrophil count (ANC) < 0.5 X 10^9 k/ul

• Female patients who are pregnant or lactating

• Patients with reproductive potential who are unwilling to following contraception requirements (including condom use for males with sexual partners, and for females: prescription oral contraceptives [birth control pills], contraceptive injections, intrauterine devices [IUD], double-barrier method [spermicidal jelly or foam with condoms or diaphragm], contraceptive patch, or surgical sterilization) throughout the study. Reproductive potential is defined as no previous surgical sterilization or females that are not post-menopausal for 12 months.

• Female patients with reproductive potential who do not have a negative urine or blood beta-human chorionic gonadotropin (beta HCG) pregnancy test at screening.

• History of an active malignancy within the past 2 years prior to study entry, with the exception of:

• Adequately treated in situ carcinoma of the cervix uteri

• Adequately treated basal cell carcinoma or localized squamous cell carcinoma of the skin

• Patients receiving any other concurrent investigational agent or chemotherapy, radiotherapy, or immunotherapy (within 14 days of initiating study treatment)