Study on Tagraxofusp and Decitabine for Treating Chronic Myelomonocytic Leukemia
Sponsor: M.D. Anderson Cancer Center
ClinicalTrials ID:NCT05038592
This clinical trial is exploring the effects and best dosage of two drugs, tagraxofusp and decitabine, in treating patients with chronic myelomonocytic leukemia. The study aims to see if these drugs can help control the disease by targeting and killing cancer cells.
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Program Overview
This study is testing a combination of two drugs, tagraxofusp and decitabine, to see if they can effectively treat chronic myelomonocytic leukemia (CMML). Tagraxofusp is designed to attach to specific cancer cells and deliver a toxic substance to kill them. Decitabine is a chemotherapy drug that works by stopping cancer cells from growing and spreading. The trial will assess the safety, best dose, and effectiveness of this combination in controlling the disease.
Description
The main goals of this study are to determine how safe and tolerable the combination of tagraxofusp and decitabine is, and to find the best dose to use. Researchers will also look at how well the treatment works in reducing the cancer and improving patient outcomes.
The study is divided into two phases. In the first phase, different doses of tagraxofusp will be tested to find the safest and most effective amount. In the second phase, the focus will be on how well the treatment works in controlling the cancer.
Participants will receive decitabine through an IV for five days and tagraxofusp for three days. This cycle will repeat every 28 days, as long as the treatment is effective and side effects are manageable. After finishing the treatment, patients will have follow-up visits every three months to monitor their health and response to the therapy.
Eligibility Criteria
Inclusion Criteria
- Must be 18 years or older.
- Diagnosed with specific types of blood disorders, including chronic myelomonocytic leukemia (CMML) or other related conditions.
- Must have tried other treatments without success or have a specific type of CMML that has not been treated before.
- Must be in relatively good health, with a performance status score between 0 and 2.
- Must have normal heart function and no significant heart problems.
- Must have normal kidney and liver function as shown by specific blood tests.
- Women of childbearing potential must have a negative pregnancy test before starting treatment.
- Must agree to use effective birth control during the study and for two months after the last dose of tagraxofusp.
- Must be willing to follow the study schedule and procedures, including regular follow-up visits.
- Must provide informed consent to participate in the study.
Exclusion Criteria
- Cannot have severe side effects from previous cancer treatments that are not easily managed.
- Cannot have received chemotherapy, radiation, or other cancer treatments within 14 days before starting the study.
- Cannot have previously received tagraxofusp or be allergic to any of its components.
- Cannot have another active cancer that requires treatment, except for certain non-threatening types like skin cancer.
- Cannot have significant heart disease or uncontrolled lung disease.
- Cannot have active or suspected cancer in the central nervous system.
- Cannot be on immunosuppressive therapy, except for low-dose steroids or specific medications for preventing graft-versus-host disease.
- Cannot have uncontrolled infections or other serious illnesses that would interfere with the study.
- Cannot be pregnant or breastfeeding.
- Cannot have HIV or active hepatitis B or C infections.
- Cannot be dependent on oxygen.
- Cannot have any medical condition that poses a high risk for severe side effects.
- Hydroxyurea is allowed only if it was being used before the study and only during the first cycle of treatment.
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