Acute Myeloid LeukemiaNCT06256627
The Maintenance Treatment of "ITIVA" in AML Patients
A study testing recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine in people with Acute Myeloid Leukemia and Maintenance Treatment, run by Henan Cancer Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Acute Myeloid Leukemia, Maintenance Treatment, Minor Residue Disease
- What is being tested?
- recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- 11 Jul 2023to 1 May 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Male or female, ≥ 14 years old.
- According to the WHO (2016) diagnostic criteria, the diagnosis of newly diagnosed AML is met (excluding APL).
- After conventional induction and chemotherapy with at least two consolidation schemes (at least one cycle of the scheme containing medium dose or above of Cytarabine, or the scheme of "vinecla combined with Azacitidine" gets remission, and continues to use the scheme to consolidate at least 6-8 cycles), CR or CRI can be achieved.
- <6 months from the last chemotherapy.
- Having sufficient organ functions: creatinine clearance rate ≥ 30 mL/min; Bilirubin<3.0 × Upper limit of normal value (ULN) (sufficient liver function level); Platelets ≥ 50 × 10^9/L; Neutrophil count ≥ 1 × 10^9/L in granulocyte stimulated hematopoietic therapy
- Whole body functional state score (ECOG) 0-2 points
- The subjects are willing and able to follow the process required by this protocol.
Who cannot join
- Have a history of APL.
- Morphologically recurrent or refractory AML patients.
- Previous history of prodromal hematological diseases or treatment-related AML.
- MRD positive patients are scheduled to undergo allogeneic hematopoietic stem cell transplantation within one month. Patients with negative MRD are scheduled to undergo allogeneic hematopoietic stem cell transplantation within 6 months. Patients who have previously received allogeneic hematopoietic stem cell transplantation.
- There is a history of AML active central nervous system involvement.
- HIV infected patients.
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- Uncontrolled infection.
- Merge New York Heart Association>Level 2 Cardiovascular Dysfunction Status. Level 2 is defined as heart disease where the subject feels comfortable during rest, but regular physical activity can lead to fatigue, palpitations, breathing difficulties, or angina.
- With chronic Respiratory disease, continuous oxygen inhalation is required, with major medical history of kidney, nerve, spirit, endocrine, metabolism, immunity, liver, cardiovascular disease, or with any other medical condition that the investigator believes will adversely affect his/her participation in this study.
- Complicated with Malabsorption syndrome or other diseases that hinder the administration of drugs through the intestinal route.
- Evidence of other clinically significant uncontrollable systemic infections (viruses, bacteria, or fungi) that require treatment.
- There are mental illnesses/social situations that may affect research compliance.
- History of merging other malignant tumors under treatment
- There is a clinically significant medical history or any other reason that the researcher believes will hinder the subject's participation in this study, or make the subject unsuitable for receiving the study drug.
- There is a history of allergic reactions or significant sensitivity to the ingredients of the investigational drug (and its excipients) and/or other similar products.
- The subjects are not allowed to receive other anti AML treatments. Non tumor disease treatment drugs can continue to be used.
- Female subjects with Fertility need to take contraceptive measures.
- There have been venous or arterial thromboembolic events within the past 6 months.
- Other researchers believe that it is not suitable for enrollment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Affiliated Cancer Hospital of Zhengzhou University and Henan Cancer Hospital
Zhengzhou, Henan, 450000
Lin Wang, Doctor, +8613203739652, 13020025628@163.com
About this study
Official title: 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
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
- Being tested
- recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and AzacitidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Analyzing the effect of "IFN-α- 1b, il-2, and thalidomide" on negative conversion rate of MRD . | Active comparator | Analyzing the effect of "interference'- α- 1b, interleukin-2, and thalidomide" on negative conversion rate of MRD in AML patients who have obtained CR or CRi but are MRD positive after routine induction and consolidation chemotherapy Receives: Drug: recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine |
| To evaluate whether the "ITIVA" regimen as maintenance treatment can improveRFS in AML patients | Active comparator | To evaluate whether the combination of "recombinant human interference'- α- 1b, interleukin-2, and thalidomide", Venentoclax and Azacitidine triple alternative maintenance treatment can improve relapse free survival (RFS) in AML patients who have achieved CR or CRi through conventional induction and consolidation chemotherapy Receives: Drug: recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the negative MRD conversion rate of AML patients and whether the combination of triple maintenance treatment can improve relapse free survival (RFS) in AML patients
To evaluate the negative MRD conversion rate of AML patients after "interference'- α- 1b, interleukin-2, and thalidomide" treatment and whether triple maintenance treatment can improve relapse free survival (RFS) in AML patients who have achieved CR or CRi through conventional induction and consolidation chemotherapy
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start11 Jul 2023
- Primary completion1 Mar 2025 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Xudong None Wei, Doctor/Professor, Principal investigator, Cancer Hospital of Henan Province
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256627
- Sponsor's protocol ID
- 2022-548-002
- Status last verified
- Aug 2023
- First submitted
- 5 Feb 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06256627
- Acronym / sponsor ID
- 2022-548-002
- Conditions
- Acute Myeloid Leukemia, Maintenance Treatment, Minor Residue Disease, Interferon-α-1b, Interleukin-2, Thalidomide
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Analyzing the effect of "IFN-α- 1b, il-2, and thalidomide" on negative conversion rate of MRD . | Active comparator | Drug: recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and AzacitidineAnalyzing the effect of "interference'- α- 1b, interleukin-2, and thalidomide" on negative conversion rate of MRD in AML patients who have obtained CR or CRi but are MRD positive after routine induction and consolidation chemotherapy |
| To evaluate whether the "ITIVA" regimen as maintenance treatment can improveRFS in AML patients | Active comparator | Drug: recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and AzacitidineTo evaluate whether the combination of "recombinant human interference'- α- 1b, interleukin-2, and thalidomide", Venentoclax and Azacitidine triple alternative maintenance treatment can improve relapse free survival (RFS) in AML patients who have achieved CR or CRi through conventional induction and consolidation chemotherapy |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female, ≥ 14 years old.
- According to the WHO (2016) diagnostic criteria, the diagnosis of newly diagnosed AML is met (excluding APL).
- After conventional induction and chemotherapy with at least two consolidation schemes (at least one cycle of the scheme containing medium dose or above of Cytarabine, or the scheme of "vinecla combined with Azacitidine" gets remission, and continues to use the scheme to consolidate at least 6-8 cycles), CR or CRI can be achieved.
- <6 months from the last chemotherapy.
- Having sufficient organ functions: creatinine clearance rate ≥ 30 mL/min; Bilirubin<3.0 × Upper limit of normal value (ULN) (sufficient liver function level); Platelets ≥ 50 × 10^9/L; Neutrophil count ≥ 1 × 10^9/L in granulocyte stimulated hematopoietic therapy
Key exclusion criteria (19 listed)
- Have a history of APL.
- Morphologically recurrent or refractory AML patients.
- Previous history of prodromal hematological diseases or treatment-related AML.
- MRD positive patients are scheduled to undergo allogeneic hematopoietic stem cell transplantation within one month. Patients with negative MRD are scheduled to undergo allogeneic hematopoietic stem cell transplantation within 6 months. Patients who have previously received allogeneic hematopoietic stem cell transplantation.
- There is a history of AML active central nervous system involvement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and AzacitidinePatients 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. | Drug | Analyzing the effect of "IFN-α- 1b, il-2, and thalidomide" on negative conversion rate of MRD ., To evaluate whether the "ITIVA" regimen as maintenance treatment can improveRFS in AML patients |
Primary outcome
the negative MRD conversion rate of AML patients and whether the combination of triple maintenance treatment can improve relapse free survival (RFS) in AML patients
Time frame: 2 years
To evaluate the negative MRD conversion rate of AML patients after "interference'- α- 1b, interleukin-2, and thalidomide" treatment and whether triple maintenance treatment can improve relapse free survival (RFS) in AML patients who have achieved CR or CRi through conventional induction and consolidation chemotherapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xudong None Wei, Doctor/Professor principal investigator
Cancer Hospital of Henan Province
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing recombinant human interference'- α- 1b, interleukin-2, thalidomide, Venentoclax and Azacitidine in people with Acute Myeloid Leukemia and Maintenance Treatment, run by Henan Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lin Nonene Wang, Doctor (+8613203739652, 13020025628@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the negative MRD conversion rate of AML patients and whether the combination of triple maintenance treatment can improve relapse free survival (RFS) in AML patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2024.