RecruitingNot ApplicableNCT06256627

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

Sponsor

Henan Cancer Hospital

Enrollment

130 participants

Start Date

Jul 11, 2023

Study Type

INTERVENTIONAL

Conditions

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

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

Min Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a maintenance treatment called "ITIVA" for people with acute myeloid leukemia (AML) — a type of blood cancer. After completing chemotherapy and reaching remission, this trial explores whether continuing treatment can help prevent the cancer from coming back. **You may be eligible if...** - You are 14 years old or older - You have been diagnosed with AML (not a type called APL) - You completed at least two rounds of chemotherapy and achieved remission (cancer is not detectable) - Your last chemotherapy was less than 6 months ago - Your kidney, liver, and blood counts meet certain minimum levels - You are generally functioning well day-to-day (ECOG score 0–2) **You may NOT be eligible if...** - You have or had the APL subtype of leukemia - Your AML has relapsed or did not respond to treatment - Your AML developed as a result of a prior blood disorder or previous chemotherapy - You are scheduled for or have already had a bone marrow transplant - You have HIV, an uncontrolled infection, or significant heart or lung disease - You have had blood clots in the veins or arteries in the past 6 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGrecombinant 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.

Locations(1)

The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital

Zhengzhou, Henan, China

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NCT06256627

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