Actively Recruiting
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
Led by Henan Cancer Hospital · Updated on 2024-02-13
130
Participants Needed
1
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of a combined regimen of recombinant human interferon-alpha-1b, interleukin-2, and thalidomide in patients with acute myeloid leukemia (AML) who have achieved complete remission but remain minimal residual disease (MRD) positive. The study also assesses the alternating maintenance treatment using venetoclax and azacitidine along with this combined regimen in AML patients who are MRD negative after initial chemotherapy. The trial aims to analyze MRD conversion rates and long-term survival in these patient groups. The study includes two groups of AML patients. The first group, those who are MRD positive after induction and consolidation chemotherapy, will be randomly assigned to receive two cycles of either the combined interferon-alpha-1b, interleukin-2, and thalidomide treatment or the venetoclax and azacitidine regimen. The second group, who are MRD negative after chemotherapy, will receive an alternating triple maintenance treatment involving these three regimens over eight cycles, each cycle lasting 28 days, with adjustments based on blood counts. Participants will undergo regular evaluations including measurement of MRD status to determine treatment response. The primary outcome is the negative MRD conversion rate and relapse-free survival over two years. Participants' organ function, blood counts, and overall health status will be monitored throughout the study. The study spans up to two years to assess long-term treatment effects and safety under the supervision of the research team.
CONDITIONS
Brief 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 according to WHO 2016 criteria, excluding APL
- Achieved complete remission (CR) or complete remission with incomplete blood count recovery (CRi) after induction and at least two consolidation chemotherapy cycles
- Last chemotherapy completed less than 6 months ago
- Adequate organ function: creatinine clearance rate at least 30 mL/min; bilirubin less than 3 times the upper limit of normal; platelets at least 50 x 10^9/L; neutrophil count at least 1 x 10^9/L
- ECOG performance status score of 0 to 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
- Scheduled for allogeneic hematopoietic stem cell transplantation soon or previously received it
- Active central nervous system involvement of AML
- HIV infection
- Uncontrolled infection
- New York Heart Association class greater than 2 cardiovascular dysfunction
- Chronic respiratory disease requiring continuous oxygen
- Major medical history affecting kidneys, nerves, mental health, endocrine, metabolism, immunity, liver, or cardiovascular system
- Conditions hindering oral drug administration
- Uncontrolled systemic infections
- Mental illnesses or social situations affecting compliance
- Under treatment for other malignant tumors
- Significant medical history or conditions making participation unsuitable
- Allergic reactions to study drugs or similar products
- Not allowed to receive other anti-AML treatments
- Female participants with fertility must use contraception
- Venous or arterial thromboembolic events within past 6 months
- Other reasons deemed unsuitable by researchers
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 cycles of 28 days each
Participants receive the ITIVA maintenance treatment regimen consisting of recombinant human interferon-α-1b, interleukin-2, thalidomide, Venentoclax, and Azacitidine in cycles lasting 28 days each. The treatment includes three alternative regimens combined into one cycle and is maintained for a total of 8 cycles. The number of days administered per cycle may be adjusted based on the participant's blood count.
Visits occur according to treatment cycles with possible adjustments based on blood counts
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
L
Lin None Chen, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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