Clinical trial NCT06256627: The Maintenance Treatment of "ITIVA" in AML Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Myeloid Leukemia
Maintenance Treatment
Minor Residue Disease
Interferon-α-1b
Interleukin-2
Thalidomide
Venentoclax
Azacitidine
Lead sponsor: Henan Cancer Hospital
Sponsor class: OTHER_GOV
First posted: 2024-02-13
Enrollment: 130
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: We apply for this clinical study to evaluate the efficacy of "combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide" regimen in obtaining MRD positive AML patients in CR,as well as the efficacy of the "Venentoclax and azacitidine" regimen and the "combined recombinant human interference'- α- 1b, interleukin-2, and thalidomide" regimen in alternately maintaining the treatment of MRD negative AML patients. The study included two cohorts. The first cohort consisted of AML patients who obtained CR or CRi but MRD positive after induction chemotherapy and consolidation chemotherapy. They were randomly given two cycles of "recombinant human interference'- α- 1b, interleukin-2, and thalidomide" or "VA" regimen treatment, and the MRD conversion rates of the two groups were analyzed. In the second cohort , after induction chemotherapy and consolidation chemotherapy, AML patients with CR or CRi and negative MRD were obtained, and were given "recombinant human interference'- α- 1b, interleukin-2, and thalidomide", Venentoclax and Azacitidine triple alternative maintenance treatment, to analyze the impact of maintenance treatment scheme on long-term survival of aml patients.


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.

Primary outcomes:
measure: the negative MRD conversion rate of AML patients and whether the combination of triple maintenance treatment can improve relapse free survival (RFS) in AML patients
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
state: Henan
Study officials:
affiliation: Cancer Hospital of Henan Province
name: Xudong None Wei, Doctor/Professor
role: PRINCIPAL_INVESTIGATOR
References: