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The Maintenance Treatment of "ITIVA" in AML Patients | Clinical Trials | Clareo Health

RECRUITINGNA

The Maintenance Treatment of "ITIVA" in AML Patients

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

NCT06256627•Henan Cancer Hospital

View on ClinicalTrials.gov

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

Age

14 - No limit years

Sex

ALL

Healthy Volunteers

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.
+9 more criteria

Locations (1)

The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital

Zhengzhou, Henan, China

Key Dates

Start Date

July 11, 2023

Primary Completion Date

March 1, 2025

Completion Date

May 1, 2027

Last Updated

February 13, 2024

Enrollment

130

ESTIMATED participants

Conditions

Acute Myeloid LeukemiaMaintenance TreatmentMinor Residue DiseaseInterferon-α-1bInterleukin-2ThalidomideVenentoclaxAzacitidine

Interventions

recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine

DRUG

Contacts

Lin Nonene Wang, Doctor

CONTACT

+8613203739652 13020025628@163.com

Lin None Chen, Doctor

CONTACT

+8615514511219 chenlinms@yeah.net

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 13, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Maintenance Treatment of "ITIVA" in AML Patients

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

VAC Regimen for AML Patients Who Failed to Response to VA Regimen

A Study of Revumenib in R/R Leukemias Including Those With an MLL/KMT2A Gene Rearrangement or NPM1 Mutation

Phase III Study of Induction and Consolidation Chemotherapy With Venetoclax in Patients With Newly Diagnosed AML or MDS-EB-2

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