Tagraxofusp + Decitabine for Chronic Myelomonocytic Leukemia
Trial Summary
What is the purpose of this trial?
This phase I/II trial studies the side effects, best dose, and effect of tagraxofusp and decitabine in treating patients with chronic myelomonocytic leukemia. Tagraxofusp consists of human interleukin 3 (IL3) linked to a toxic agent called DT388. IL3 attaches to IL3 receptor positive cancer cells in a targeted way and delivers DT388 to kill them. Chemotherapy drugs, such as decitabine, work 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 tagraxofusp and decitabine may help to control the disease in patients with chronic myelomonocytic leukemia.
Will I have to stop taking my current medications?
The trial protocol does not specify if you must stop taking your current medications. However, if you are taking hydroxyurea, you may continue it during the first cycle of the study, and possibly beyond with approval from the Principal Investigator.
What data supports the effectiveness of the drug Tagraxofusp + Decitabine for Chronic Myelomonocytic Leukemia?
Research shows that Decitabine, a part of the treatment, has been effective in treating Chronic Myelomonocytic Leukemia (CMML) with an overall response rate of 47.6% in a study, and it is approved for use in CMML. Additionally, Decitabine combined with Cedazuridine has been approved for CMML, indicating its effectiveness in this condition.12345
What safety data exists for Tagraxofusp + Decitabine treatment in humans?
Decitabine, used in combination with cedazuridine, has been studied for safety in treating conditions like myelodysplastic syndromes and chronic myelomonocytic leukemia. Common side effects include low blood cell counts, such as neutropenia (low white blood cells), thrombocytopenia (low platelets), and anemia (low red blood cells). These side effects are generally manageable, and the treatment is considered well-tolerated in patients.35678
What makes the drug Tagraxofusp + Decitabine unique for treating chronic myelomonocytic leukemia?
The combination of Tagraxofusp and Decitabine is unique because it combines a targeted therapy (Tagraxofusp) with a hypomethylating agent (Decitabine), potentially offering a novel approach for chronic myelomonocytic leukemia, which lacks effective treatments. Additionally, Decitabine's oral formulation with cedazuridine improves its bioavailability, making it more convenient compared to traditional intravenous administration.135910
Research Team
Guillermo M. Bravo
Principal Investigator
M.D. Anderson Cancer Center
Eligibility Criteria
This trial is for adults with chronic myelomonocytic leukemia (CMML) who haven't tried hypomethylating agents or have no response after 6 cycles of such treatments. They should be in good heart health, have acceptable organ function, and not be pregnant. Participants must agree to use contraception and can't join if they've had recent other cancer treatments, significant heart or lung disease, active infections like HIV or hepatitis B/C, or are on certain immunosuppressants.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive decitabine IV over 60 minutes on days 1-5, and tagraxofusp-erzs IV over 15 minutes on days 1-3. Cycles of decitabine repeat every 28 days, and tagraxofusp-erzs repeats every 28 days for up to 7 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion every 3 months.
Treatment Details
Interventions
- Decitabine
- Tagraxofusp-erzs
Decitabine is already approved in European Union, United States, Canada, Japan for the following indications:
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
- Myelodysplastic syndromes
- Acute myeloid leukemia
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor