The Maintenance Treatment of "ITIVA" in AML Patients

Launched by HENAN CANCER HOSPITAL · Feb 5, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating new treatment options for patients with Acute Myeloid Leukemia (AML), particularly those who have had a positive response to initial chemotherapy but still have some cancer cells remaining (known as minimal residual disease, or MRD). The study is looking at two different groups: one group includes patients who still have MRD after chemotherapy, and they will receive either a combination of specific treatments (interferon-α-1b, interleukin-2, and thalidomide) or a different regimen involving venetoclax and azacitidine. The second group consists of patients who have fully responded to treatment and no longer have detectable MRD; they will receive a combination of the same treatments as the first group to see how well it helps them stay cancer-free over a longer period.

To be eligible for this trial, participants must be at least 14 years old and have been diagnosed with AML, excluding a specific type called APL. They should have responded to chemotherapy and have good organ function. However, those with certain health issues, past histories of specific diseases, or those who are currently being treated for other cancers may not be eligible. Participants can expect to receive treatment under careful medical supervision and will be monitored closely for their response to the drugs and any side effects. This trial aims to find effective maintenance therapies that can help prevent the return of AML and improve long-term survival for patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female, ≥ 14 years old.
• • 2. According to the WHO (2016) diagnostic criteria, the diagnosis of newly diagnosed AML is met (excluding APL).
• • 3. After conventional induction and chemotherapy with at least two consolidation schemes (at least one cycle of the scheme containing medium dose or above of Cytarabine, or the scheme of "vinecla combined with Azacitidine" gets remission, and continues to use the scheme to consolidate at least 6-8 cycles), CR or CRI can be achieved.
• • 4. \<6 months from the last chemotherapy.
• • 5. Having sufficient organ functions: creatinine clearance rate ≥ 30 mL/min; Bilirubin\<3.0 × Upper limit of normal value (ULN) (sufficient liver function level); Platelets ≥ 50 × 10\^9/L; Neutrophil count ≥ 1 × 10\^9/L in granulocyte stimulated hematopoietic therapy
• • 6. Whole body functional state score (ECOG) 0-2 points
• • 7. The subjects are willing and able to follow the process required by this protocol.
• Exclusion Criteria:
• • 1. Have a history of APL.
• • 2. Morphologically recurrent or refractory AML patients.
• • 3. Previous history of prodromal hematological diseases or treatment-related AML.
• • 4. MRD positive patients are scheduled to undergo allogeneic hematopoietic stem cell transplantation within one month. Patients with negative MRD are scheduled to undergo allogeneic hematopoietic stem cell transplantation within 6 months. Patients who have previously received allogeneic hematopoietic stem cell transplantation.
• • 5. There is a history of AML active central nervous system involvement.
• • 6. HIV infected patients.
• • 7. Uncontrolled infection.
• • 8. Merge New York Heart Association\>Level 2 Cardiovascular Dysfunction Status. Level 2 is defined as heart disease where the subject feels comfortable during rest, but regular physical activity can lead to fatigue, palpitations, breathing difficulties, or angina.
• • 9. With chronic Respiratory disease, continuous oxygen inhalation is required, with major medical history of kidney, nerve, spirit, endocrine, metabolism, immunity, liver, cardiovascular disease, or with any other medical condition that the investigator believes will adversely affect his/her participation in this study.
• • 10. Complicated with Malabsorption syndrome or other diseases that hinder the administration of drugs through the intestinal route.
• • 11. Evidence of other clinically significant uncontrollable systemic infections (viruses, bacteria, or fungi) that require treatment.
• • 12. There are mental illnesses/social situations that may affect research compliance.
• • 13. History of merging other malignant tumors under treatment
• • 14. There is a clinically significant medical history or any other reason that the researcher believes will hinder the subject's participation in this study, or make the subject unsuitable for receiving the study drug.
• • 15. There is a history of allergic reactions or significant sensitivity to the ingredients of the investigational drug (and its excipients) and/or other similar products.
• • 16. The subjects are not allowed to receive other anti AML treatments. Non tumor disease treatment drugs can continue to be used.
• • 17. Female subjects with Fertility need to take contraceptive measures.
• • 18. There have been venous or arterial thromboembolic events within the past 6 months.
• • 19. Other researchers believe that it is not suitable for enrollment.