NCT06256627

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 130 (estimated)
• Sponsor: Henan Cancer Hospital · Other Government
• Sex: All
• Age: 14 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DRUG	recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine	Patients in arm1 were randomly divided into two groups, namely the " interference'- α- 1b, interleukin-2, thalidomide" treatment group and the "VA" treatment group. After receiving a two cycle protocol, patients were evaluated for the endpoint of the trial and their MRD conversion rate was calculated. Patients in arm2 will receive triple maintenance treatment, completing three alternative regimens into one cycle. The regimen maintenance treatment will be maintained for a total of 8 cycles. Each medication regimen takes 28 days as a cycle. The number of days administered per cycle can be adjusted based on the patient's blood count.

Timeline

• Start date: 2023-07-11
• Primary completion: 2025-03-01
• Completion: 2027-05-01
• First posted: 2024-02-13
• Last updated: 2024-02-13

Locations

1 site across 1 country: China