Acute Myeloid LeukemiaNCT05909293
Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With AML in First Complete Remission
A study testing Venclexta 100 MG Oral Tablet in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission. This study involves the following content: BCL-2 inhibitors. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venclexta 100 MG Oral Tablet
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 12 Apr 2023to 30 May 2028
- 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 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with acute myeloid leukemia (AML) diagnosed based on bone marrow morphology and immunophenotyping (meeting the diagnostic criteria of WHO 2016).
- Achieving first complete remission (CR) or incomplete complete remission (CRi) after 1-2 cycles of induction therapy and receiving consolidation treatment for at least 4 cycles.
- Age between 60 and 85 years.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3 times the upper limit of normal (ULN), serum bilirubin ≤ 1.5 times ULN, serum creatinine ≤ 2.0 times ULN, and serum creatine kinase < 2.0 times ULN.
- Left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiography.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-3. Obtaining informed consent from the patient or their legal representative.
Who cannot join
- Acute promyelocytic leukemia, myeloid sarcoma, blast phase of chronic myeloid leukemia.
- Patients who achieve CR after relapse and re-induction therapy.
- Extramedullary involvement of AML, including active central nervous system leukemia.
- Allergy to any of the drugs involved in the protocol. Pregnant or lactating women and reproductive-age patients who are unwilling to use contraception.
- Significant abnormalities in liver or kidney function beyond the inclusion criteria.
- Presence of organic heart disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction with clinical symptoms or cardiac dysfunction within the past 6 months (according to New York Heart Association functional classification NYHA ≥ 3).
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- Concurrent presence of other malignant tumors, except for the following conditions:
- Patients who have received curative-intent treatment and have not had any known active disease of malignant tumors for ≥ 5 years before enrollment.
- Patients who have received adequate treatment and do not show signs of disease for non-melanoma skin cancer or malignant melanocytic nevi (even if it is within 3 years before randomization).
- Patients who have received adequate treatment and do not show signs of disease for in situ carcinoma (even if it is within 3 years before randomization).
- Patients with HIV/AIDS, syphilis, active hepatitis B (detectable HBV-DNA), and hepatitis C.
- Any concurrent medical condition or disease (such as active systemic infection) that may interfere with the study procedures or results or pose risks to the participant as determined by the investigator.Inability to understand or comply with the study protocol.
- Patients younger than 60 years or older than 85 years.
- Undergoing major surgery within 4 weeks prior to randomization.
- Patients who have undergone allogeneic hematopoietic stem cell transplantation.
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 First Affiliated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210000
Ming Hong, +8613914722662, minniehm122@163.com
About this study
Official title: Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission
This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission.
This study involves the following content: BCL-2 inhibitors.
Read the detailed description
This is a prospective, multicenter, open-label, single-arm clinical study that aims to observe the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission.
The FDA has approved the combination therapy of Venetoclax and Decitabine/Azacitidine for elderly (>60 years old) newly diagnosed AML patients who are not eligible for intensive chemotherapy. Venetoclax, the first highly selective BCL-2 inhibitor available globally, is a BH3 mimetic that selectively binds to the BCL-2 protein, displacing and releasing pro-apoptotic proteins that were originally bound to BCL-2, effectively inducing apoptosis in tumor cells.
In recent years, maintenance therapy for elderly AML patients has also been under continuous exploration. In 2020, Andrew et al. published clinical trial results in the New England Journal of Medicine, demonstrating the use of oral Azacitidine formulation (CC-486) as maintenance therapy for elderly AML patients who achieved their first complete remission (CR1).
Considering the high response rate achieved by BCL-2 inhibitors in treating elderly AML and the tolerable adverse effects, maintenance therapy has shown survival benefits and good safety profiles in elderly AML patients. Therefore, your plan is to further explore, refine, and optimize treatment strategies for elderly AML patients by administering BCL-2 inhibitor maintenance therapy to those who have achieved their first CR, evaluating patient overall survival (OS), relapse-free survival (RFS), and treatment safety through a comparative study with a control group. This aims to preliminarily establish the role of this maintenance regimen in the treatment of elderly AML.
Participants will be recruited within 24 months from the completion of consolidation therapy, and the BCL-2 inhibitor maintenance therapy will last for 12 cycles, with each cycle consisting of 28 days. The analysis will be conducted approximately 48 months after the enrollment of the first patient and the follow-up will continue for 2 years from the randomization of the last patient.
Specific protocol:
During the consolidation phase, which occurs within 2 months after the completion of consolidation therapy, the BCL-2 inhibitor maintenance treatment will consist of 12 cycles, with each cycle lasting 28 days.
The specific regimen for the BCL-2 inhibitor is as follows:
BCL-2 inhibitor: 400mg/day, orally, from day 1 to day 14 of each cycle.
The target is to enroll 100 eligible patients.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venclexta 100 MG Oral Tablet
- 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.
Venclexta 100 MG Oral TabletDrug
Also called Granulocyte colony-stimulating factor (G-CSF), Interleukin-11 (IL-11), Antibiotics, Blood products
When there is a deficiency of neutrophils, G-CSF treatment may be necessary. The treatment is continued until the absolute neutrophil count (ANC) reaches either >0.5×109/L and remains at that level for 3 consecutive days, or >2×109/L. The purpose of G-CSF therapy in this context is to stimulate the production of neutrophils and restore their levels to a sufficient and stable range. This helps to strengthen the immune system and reduce the risk of infections associated with low neutrophil counts.
When experiencing Grade 3-4 thrombocytopenia, subcutaneous injection of IL-11 can be administered as a treatment.
When symptoms of infection occur, aggressive antimicrobial therapy and other supportive treatments should be administered.
All blood products should undergo irradiation when transfused, and all blood products must be filtered before infusion.
If gastrointestinal adverse reactions occur, antiemetic medications can be administered to alleviate symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Venclexta | Experimental | During the consolidation phase, which occurs within 2 months after the completion of consolidation therapy, the BCL-2 inhibitor maintenance treatment will consist of 12 cycles, with each cycle lasting 28 days.
The specific regimen for the Venclexta is as follows:
Venclexta: 400mg/day, orally, from day 1 to day 14 of each cycle. Receives: Drug: Venclexta 100 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
2-year overall survival (OS)
2-year overall survival (OS) refers to the percentage of patients who are alive 2 years after a certain event or treatment.The time from diagnosis to patient death or the end of follow-up is calculated.
Measured: From the time of CR/CRi to time for up to 2 years
Recurrence-free survival (RFS)
The term "Recurrence-free survival (RFS)" refers to the period of time starting from the point of complete remission (CR) or incomplete complete remission (CRi) and ending at the occurrence of leukemia relapse or any event leading to death. During this period, the patient does not experience a relapse or progression of leukemia and does not die from other causes. RFS is an important measure of survival used to assess the effectiveness of treatment in controlling leukemia relapse.
Measured: From the time of CR/CRi to time for up to 2 years
Secondary outcomes (3)
Assessment of efficacy.
CR definition: Bone marrow blast percentage less than 5%, no Auer rods, no evidence of extramedullary leukemia, peripheral blood neutrophil count greater than 1×10^9/L, and platelet count greater than 100×10^9/L. The time for hematologic recovery after induction therapy is calculated from the first day of chemotherapy.
CRi definition: Meets all CR criteria except for ANC < 1×10^9/L or platelet count < 100×10^9/L.
Relapse definition: Reappearance of leukemia cells in the peripheral blood after achieving CR, or bone marrow blast percentage > 5% (excluding other causes such as bone marrow regeneration after consolidation therapy), or extramedullary leukemia cell infiltration.
Measured: At the end of the 6 cycle of treatment, which corresponds to 28 days per cycle.
The impact of maintenance therapy on minimal residual disease (MRD) kinetics.
Definition of minimal residual disease (MRD): The presence of residual leukemia cells below the threshold detected by conventional morphological methods. In this study, MRD was assessed using second-generation sequencing (NGS), real-time quantitative PCR, and multiparameter flow cytometry techniques.
Measured: From the time of CR/CRi to time for up to 2 years
Safety evaluation
Adverse reactions will be assessed according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which provides grading standards for acute and subacute toxicities of anticancer drugs.
Measured: From the time of CR/CRi to time for up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start12 Apr 2023
- Primary completion30 May 2025 (estimated)
- Study completion30 May 2028 (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 The First Affiliated Hospital with Nanjing Medical UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Huai'an First People's Hospital, Yancheng First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909293
- Sponsor's protocol ID
- 2022-SR-541
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 18 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol of Maintenance Therapy With Venetoclax in Elderly Patients With Acute Myeloid Leukemia (AML) in First Complete Remission
- ClinicalTrials.gov ID
- NCT05909293
- Acronym / sponsor ID
- 2022-SR-541
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital with Nanjing Medical UniversityUniversity, hospital or other
- Collaborators
- Huai'an First People's Hospital, Yancheng First People's Hospital
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 18 Jun 2023 (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.
This clinical study evaluates the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission.
This study involves the following content: BCL-2 inhibitors.
Detailed description
This is a prospective, multicenter, open-label, single-arm clinical study that aims to observe the efficacy and safety of maintenance therapy with BCL-2 inhibitors in elderly patients with acute myeloid leukemia (AML) in first complete remission.
The FDA has approved the combination therapy of Venetoclax and Decitabine/Azacitidine for elderly (>60 years old) newly diagnosed AML patients who are not eligible for intensive chemotherapy. Venetoclax, the first highly selective BCL-2 inhibitor available globally, is a BH3 mimetic that selectively binds to the BCL-2 protein, displacing and releasing pro-apoptotic proteins that were originally bound to BCL-2, effectively inducing apoptosis in tumor cells.
In recent years, maintenance therapy for elderly AML patients has also been under continuous exploration. In 2020, Andrew et al. published clinical trial results in the New England Journal of Medicine, demonstrating the use of oral Azacitidine formulation (CC-486) as maintenance therapy for elderly AML patients who achieved their first complete remission (CR1).
Considering the high response rate achieved by BCL-2 inhibitors in treating elderly AML and the tolerable adverse effects, maintenance therapy has shown survival benefits and good safety profiles in elderly AML patients. Therefore, your plan is to further explore, refine, and optimize treatment strategies for elderly AML patients by administering BCL-2 inhibitor maintenance therapy to those who have achieved their first CR, evaluating patient overall survival (OS), relapse-free survival (RFS), and treatment safety through a comparative study with a control group. This aims to preliminarily establish the role of this maintenance regimen in the treatment of elderly AML.
Participants will be recruited within 24 months from the completion of consolidation therapy, and the BCL-2 inhibitor maintenance therapy will last for 12 cycles, with each cycle consisting of 28 days. The analysis will be conducted approximately 48 months after the enrollment of the first patient and the follow-up will continue for 2 years from the randomization of the last patient.
Specific protocol:
During the consolidation phase, which occurs within 2 months after the completion of consolidation therapy, the BCL-2 inhibitor maintenance treatment will consist of 12 cycles, with each cycle lasting 28 days.
The specific regimen for the BCL-2 inhibitor is as follows:
BCL-2 inhibitor: 400mg/day, orally, from day 1 to day 14 of each cycle.
The target is to enroll 100 eligible patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venclexta | Experimental | Drug: Venclexta 100 MG Oral TabletDuring the consolidation phase, which occurs within 2 months after the completion of consolidation therapy, the BCL-2 inhibitor maintenance treatment will consist of 12 cycles, with each cycle lasting 28 days. The specific regimen for the Venclexta is as follows: Venclexta: 400mg/day, orally, from day 1 to day 14 of each cycle. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with acute myeloid leukemia (AML) diagnosed based on bone marrow morphology and immunophenotyping (meeting the diagnostic criteria of WHO 2016).
- Achieving first complete remission (CR) or incomplete complete remission (CRi) after 1-2 cycles of induction therapy and receiving consolidation treatment for at least 4 cycles.
- Age between 60 and 85 years.
- Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase (ALP) ≤ 3 times the upper limit of normal (ULN), serum bilirubin ≤ 1.5 times ULN, serum creatinine ≤ 2.0 times ULN, and serum creatine kinase < 2.0 times ULN.
- Left ventricular ejection fraction (LVEF) ≥ 50% as determined by echocardiography.
Key exclusion criteria (15 listed)
- Acute promyelocytic leukemia, myeloid sarcoma, blast phase of chronic myeloid leukemia.
- Patients who achieve CR after relapse and re-induction therapy.
- Extramedullary involvement of AML, including active central nervous system leukemia.
- Allergy to any of the drugs involved in the protocol. Pregnant or lactating women and reproductive-age patients who are unwilling to use contraception.
- Significant abnormalities in liver or kidney function beyond the inclusion criteria.
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 |
|---|---|---|
| Venclexta 100 MG Oral TabletAlso: Granulocyte colony-stimulating factor (G-CSF), Interleukin-11 (IL-11), Antibiotics, Blood productsWhen there is a deficiency of neutrophils, G-CSF treatment may be necessary. The treatment is continued until the absolute neutrophil count (ANC) reaches either >0.5×109/L and remains at that level for 3 consecutive days, or >2×109/L. The purpose of G-CSF therapy in this context is to stimulate the production of neutrophils and restore their levels to a sufficient and stable range. This helps to strengthen the immune system and reduce the risk of infections associated with low neutrophil counts. When experiencing Grade 3-4 thrombocytopenia, subcutaneous injection of IL-11 can be administered as a treatment. When symptoms of infection occur, aggressive antimicrobial therapy and other supportive treatments should be administered. All blood products should undergo irradiation when transfused, and all blood products must be filtered before infusion. If gastrointestinal adverse reactions occur, antiemetic medications can be administered to alleviate symptoms. | Drug | Venclexta |
Primary outcome
2-year overall survival (OS)
Time frame: From the time of CR/CRi to time for up to 2 years
2-year overall survival (OS) refers to the percentage of patients who are alive 2 years after a certain event or treatment.The time from diagnosis to patient death or the end of follow-up is calculated.
Recurrence-free survival (RFS)
Time frame: From the time of CR/CRi to time for up to 2 years
The term "Recurrence-free survival (RFS)" refers to the period of time starting from the point of complete remission (CR) or incomplete complete remission (CRi) and ending at the occurrence of leukemia relapse or any event leading to death. During this period, the patient does not experience a relapse or progression of leukemia and does not die from other causes. RFS is an important measure of survival used to assess the effectiveness of treatment in controlling leukemia relapse.
3 secondary outcomes
Assessment of efficacy.
Time frame: At the end of the 6 cycle of treatment, which corresponds to 28 days per cycle.
The impact of maintenance therapy on minimal residual disease (MRD) kinetics.
Time frame: From the time of CR/CRi to time for up to 2 years
Safety evaluation
Time frame: From the time of CR/CRi to time for up to 2 years
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 18 Jun 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venclexta 100 MG Oral Tablet in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital with Nanjing Medical University 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 6 inclusion and 15 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 18 Jun 2023. 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 Ming Hong, MD (+8613914722662, minniehm122@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year overall survival (OS) (time frame: From the time of CR/CRi to time for up to 2 years). The study lists 2 primary outcomes in all. 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 18 Jun 2023.