Maintenance treatment for AML patients using ITIVA

A Multicenter, Single Arm Clinical Study on the Efficacy and Safety of the "ITIVA" Protocol in Patients With Complete Remission of AML at Initial Diagnosis

This study is testing a new combination of treatments for people with Acute Myeloid Leukemia to see if it helps those who still have signs of the disease after chemotherapy and those who don’t.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 130 (estimated)
• Ages: 14 Years and up
• Sex: All
• Sponsor: Henan Cancer Hospital (other gov)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Zhengzhou, Henan)
• Trial ID: NCT06256627 on ClinicalTrials.gov

What this trial studies

This clinical study evaluates the efficacy of a combined regimen of recombinant human interferon-α-1b, interleukin-2, and thalidomide in patients with Acute Myeloid Leukemia (AML) who are MRD positive after chemotherapy. It also assesses the effectiveness of the Venetoclax and azacitidine regimen for maintaining treatment in MRD negative AML patients. The study includes two cohorts: one for MRD positive patients and another for MRD negative patients, with random assignment to different treatment regimens to analyze MRD conversion rates. The goal is to improve outcomes for AML patients in different remission states.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 14 and older with newly diagnosed AML who have achieved CR or CRi after chemotherapy.

Not a fit: Patients with a history of acute promyelocytic leukemia (APL) will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve remission rates and overall survival for AML patients.

How similar studies have performed: While similar approaches have been explored, this specific combination of treatments is novel and has not been extensively tested in prior studies.

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.

Where this trial is running

Zhengzhou, Henan

• The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital — Zhengzhou, Henan, China (RECRUITING)

Study contacts

• Principal investigator: Xudong None Wei, Doctor/Professor — Cancer Hospital of Henan Province
• Study coordinator: Lin Nonene Wang, Doctor

Conditions: Acute Myeloid Leukemia, Maintenance Treatment, Minor Residue Disease, Interferon-α-1b, Interleukin-2, Thalidomide, Venentoclax, Azacitidine