Actively Recruiting
The Maintenance Treatment of "ITIVA" in AML Patients
Led by Henan Cancer Hospital · Updated on 2024-02-13
130
Participants Needed
1
Research Sites
198 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Maintenance Treatment of "ITIVA" in AML Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female, 14 years old or older
- Diagnosed with newly diagnosed AML (excluding APL) according to WHO (2016) criteria
- Achieved complete remission (CR) or CR with incomplete hematologic recovery (CRi) after conventional induction and at least two consolidation chemotherapy cycles
- Last chemotherapy was less than 6 months ago
- Sufficient organ function: creatinine clearance 30 mL/min; bilirubin < 3 times upper normal limit; platelets 50 x 10^9/L; neutrophil count 1 x 10^9/L during stimulated hematopoiesis
- ECOG functional status score between 0 and 2
- Willing and able to follow study procedures
You will not qualify if you...
- History of acute promyelocytic leukemia (APL)
- Morphologically recurrent or refractory AML
- Previous prodromal hematological diseases or treatment-related AML
- MRD positive patients planning allogeneic hematopoietic stem cell transplantation within 1 month
- MRD negative patients planning allogeneic hematopoietic stem cell transplantation within 6 months
- Prior allogeneic hematopoietic stem cell transplantation
- Active central nervous system involvement of AML
- HIV infection
- Uncontrolled infections
- New York Heart Association Level >2 cardiovascular dysfunction
- Chronic respiratory disease requiring continuous oxygen
- Major medical history affecting kidney, nerve, mental, endocrine, metabolism, immunity, liver, or cardiovascular systems
- Malabsorption syndrome or other diseases preventing oral medication
- Clinically significant uncontrollable systemic infections
- Mental illness or social situations affecting study compliance
- Active treatment for other malignant tumors
- Allergic reactions or significant sensitivity to study drug components
- Receiving other anti-AML treatments (except non-tumor disease drugs)
- Female subjects needing contraception
- Venous or arterial thromboembolic events within past 6 months
- Any other condition judged unsuitable by the investigator for study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
Research Team
L
Lin Nonene Wang, Doctor
CONTACT
L
Lin None Chen, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here