MedTrace Logo

The Maintenance Treatment of "ITIVA" in AML Patients

NCT06256627 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2024-02-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Henan Cancer Hospital

    lead OTHER_GOV

Principal Investigators

  • Xudong None Wei, Doctor/Professor · Cancer Hospital of Henan Province

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-11
Primary Completion
2025-03-01
Completion
2027-05-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06256627 on ClinicalTrials.gov