Acute Myeloid LeukemiaNCT06232694
Clinical Study Protocol of IAV-induced Remission Followed by Consolidation Therapy With MDCyta+Ven in ND-AML
A study testing Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;, Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration; and utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT). in people with Acute Myeloid Leukemia, run by The First Affiliated Hospital with Nanjing Medical University at 1 site in China.
Trial summary
This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;, Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration; and utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2024to 30 Dec 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
- Age between 18 and 60 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
- Cardiac ultrasound LVEF ≥ 45%.
- Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
- Liver function: Aspartate aminotransferase (AST) ≤ 2.5 × ULN*; Alanine aminotransferase (ALT) ≤ 2.5 × ULN*; Total bilirubin ≤ 1.5 × ULN* (*unless considered due to leukemia infiltration).
- Signed informed consent form.
Who cannot join
- Acute promyelocytic leukemia (APL).
- Relapsed/refractory AML patients.
- AML patients with known involvement of the central nervous system (CNS).
- Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded.
- Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
- Participants with New York Heart Association (NYHA) functional classification > Grade 2. Grade 2 is defined as patients having cardiac disease with no symptoms at rest but experiencing fatigue, palpitations, dyspnea, or angina with ordinary physical activity.
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- Participants with chronic respiratory disease requiring continuous oxygen therapy.
- Patients unable to take oral medications or with malabsorption syndrome.
- Presence of uncontrolled systemic infection (viral, bacterial, or fungal).
- Participants who have previously received venetoclax treatment and/or are currently participating in any other study involving investigational drugs.
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, MD, +8613914722662, minniehm122@163.com
About this study
Official title: Clinical Study Protocol of Idarubicin, Cytarabine, and Venetoclax -Induced Remission Followed by Consolidation Therapy With Medium-dose Cytarabine Combined With Venetoclax in Newly Diagnosed Adult Acute Myeloid Leukemia
This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML).
This study includes the induction and consolidation phases of AML treatment.
Read the detailed description
This is a prospective, multicenter, open-label, single-arm clinical study aimed at observing and evaluating the effectiveness and safety of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation therapy in newly diagnosed adult AML. The results of this study will help to understand the efficacy and safety of idarubicin and cytarabine combination therapy followed by intermediate-dose cytarabine consolidation in newly diagnosed adult AML, providing guidance for clinical practice.
Acute myeloid leukemia (AML) is a heterogeneous hematopoietic stem/progenitor cell malignancy. The World Health Organization (WHO) defines AML as a myeloid tumor with primitive cells accounting for 20% or more in peripheral blood or bone marrow. It is also the most common acute leukemia in adults and the tenth leading cause of cancer-related deaths worldwide.Treatment for AML consists of induction therapy and consolidation therapy (including chemotherapy and hematopoietic stem cell transplantation (HSCT)).
The most commonly used is the 3+7 regimen. In 2018, our center conducted a retrospective analysis of 242 newly diagnosed AML patients treated with the standard IA regimen, evaluating its efficacy and adverse reactions, and conducting prognostic factor analysis. The study results showed that the CR rate of one course of IA regimen induction therapy was 81.28%; after repeated induction therapy, the CR rate reached 92.34%, confirming that the IA regimen induction therapy has a high CR rate, consistent with many literature reports.
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.
Currently, preclinical studies have confirmed that the combination of idarubicin and cytarabine with venetoclax has a synergistic effect in the anti-tumor treatment of AML. Based on this, the CAVEAT study included 51 newly diagnosed primary or secondary AML patients aged ≥65 years who had not previously received intensive therapy (including AML patients with monosomal karyotype aged ≥60 years). The median age of the patients was 72 years. The treatment regimen for induction and consolidation therapy included idarubicin, cytarabine, and venetoclax (with reduced intensity for idarubicin and cytarabine). The overall response rate (ORR) was 72%, and the median overall survival (OS) was 11.2 months. Compared to secondary AML, patients with primary AML had a longer median OS (31.3 months vs 6.1 months). The most common non-hematologic adverse reactions included febrile neutropenia (55%), sepsis (35%), and diarrhea (35%). These studies suggest that the combination of idarubicin, cytarabine, and venetoclax is safe and tolerable in elderly fit AML patients, and can provide higher remission rates and longer survival. The results of this study also partly confirm the safety of venetoclax in combination with cytarabine and idarubicin for induction chemotherapy in elderly AML patients.
Given the favorable response rates and survival benefits achieved with the combination of VEN and IA in elderly patients with primary AML, we plan to design a prospective, single-arm, multicenter exploratory clinical trial to determine the efficacy and safety of the IA-based induction regimen combined with VEN (IAV regimen) followed by consolidation therapy with intermediate-dose cytarabine and venetoclax in newly diagnosed adult AML patients. This trial aims to provide evidence-based support for novel induction and consolidation treatment strategies for this patient population.
In this study, we also plan to evaluate the efficacy and safety of the combination of idarubicin, cytarabine, and venetoclax as induction therapy followed by consolidation therapy with intermediate-dose cytarabine and venetoclax in newly diagnosed adult AML patients. The aim is to provide a safer and more effective treatment option for these patients.
After signing the informed consent form, young newly diagnosed/eligible AML patients for intensive therapy will undergo various examinations as specified during the screening period. All eligible participants who do not meet the exclusion criteria should be followed up at baseline and on days 1, 3, 5, 7, 9, 11, 13, 15, and 21 during the induction treatment phase, and on days 1 and 21 of each cycle during the consolidation treatment phase. Follow-up visits should also be conducted at the time of withdrawal from the study or at the end of the study for assessment and monitoring.
After signing the informed consent form, young newly diagnosed/fit for intensive therapy AML patients will undergo screening and various tests as specified during the screening period. All eligible participants who do not meet the exclusion criteria will be assessed at baseline and at days 1, 3, 5, 7, 9, 11, 13, 15, and 21 during the induction therapy phase, and on the first and twenty-first day of each cycle during the consolidation therapy phase. Follow-up visits will be conducted at the time of withdrawal/study completion.
Specific treatment plan:
Induction therapy:
Venetoclax: 100mg on day 1, 200mg on day 2, 400mg on days 3-8; oral administration.Idarubicin: 10-12mg/m2 on days 1-3; intravenous infusion.Cytarabine: 100mg/m2 on days 1-7; intravenous infusion or subcutaneous injection.
Consolidation therapy after remission:
Venetoclax: 400mg on days 1-7; oral administration.Cytarabine: 2g/m2 every 12 hours on days 1-3; intravenous infusion.Four cycles in total.Patients who meet the criteria for autologous stem cell transplantation (ASCT) during the treatment process can undergo ASCT.Patients who meet the transplantation criteria and have a suitable donor can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;, Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;, utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).
- 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.
Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;Drug
Also called Idarubicin (Idarubicin): 10-12mg/m2 on days 1 to 3; intravenous infusion, ;Cytarabine (Cytarabine): 100mg/m2 on days 1 to 7; intravenous infusion or subcutaneous injection.
Induction Phase Regimen
Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;Drug
Also called Cytarabine: 2g/m2 every 12 hours on day 1 to day 3; intravenous infusion;
Consolidation therapy after remission
utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).Other
Four cycles in total.Patients who meet the criteria for autologous stem cell transplantation (ASCT) during the treatment process can undergo ASCT.Patients who meet the transplantation criteria and have a suitable donor can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
| Study group | Role | What they receive |
|---|---|---|
| Induction therapy and consolidation therapy after remission | Experimental | Induction therapy:Venetoclax + idarubicin + cytarabine Consolidation therapy after remission:Venetoclax + cytarabineIf The patient meets the criteria for autologous hematopoietic stem cell transplantation (ASCT) during the treatment process, they can undergo ASCT.If the patient meets the criteria for transplantation and there is a suitable donor, they can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT). Receives: Drug: Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;; Drug: Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;; Other: utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT). |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite complete remission rate (CR+CRi)
Composite complete remission rate: the proportion of patients who achieve complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) at the end of induction therapy (CR+CRi).• CR is defined as meeting all of the following criteria: ① bone marrow blasts <5%, no circulating or Auer rod blasts; ② no extramedullary disease; ③ ANC ≥1.0 × 109 /L; ④ platelet count ≥100 × 109 /L.• CRi is defined as PLT ≤100 × 109 /L and/or ANC ≤1.0 × 109 /L, with other criteria for CR being met.
Measured: Four months from the start of initial induction therapy.
Secondary outcomes (1)
The incidence of hematological adverse reactions during induction therapy
Adverse reactions are assessed according to the grading criteria for acute and subacute toxicity reactions of anticancer drugs (WHO) (CTCAE 5.0)
Measured: Four months from the start of initial induction therapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start1 Jan 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 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 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
- 54 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
- NCT06232694
- Sponsor's protocol ID
- 2023-SR-508
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2024
- Last updated
- 31 Jan 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 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study Protocol of Idarubicin, Cytarabine, and Venetoclax -Induced Remission Followed by Consolidation Therapy With Medium-dose Cytarabine Combined With Venetoclax in Newly Diagnosed Adult Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06232694
- Acronym / sponsor ID
- 2023-SR-508
- Conditions
- Acute Myeloid Leukemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 54 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
- 1 Jan 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 31 Jan 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.
This study evaluates the efficacy and safety of the combination of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation with venetoclax in the treatment of newly diagnosed adult acute myeloid leukemia (AML).
This study includes the induction and consolidation phases of AML treatment.
Detailed description
This is a prospective, multicenter, open-label, single-arm clinical study aimed at observing and evaluating the effectiveness and safety of idarubicin and cytarabine induction followed by intermediate-dose cytarabine consolidation therapy in newly diagnosed adult AML. The results of this study will help to understand the efficacy and safety of idarubicin and cytarabine combination therapy followed by intermediate-dose cytarabine consolidation in newly diagnosed adult AML, providing guidance for clinical practice.
Acute myeloid leukemia (AML) is a heterogeneous hematopoietic stem/progenitor cell malignancy. The World Health Organization (WHO) defines AML as a myeloid tumor with primitive cells accounting for 20% or more in peripheral blood or bone marrow. It is also the most common acute leukemia in adults and the tenth leading cause of cancer-related deaths worldwide.Treatment for AML consists of induction therapy and consolidation therapy (including chemotherapy and hematopoietic stem cell transplantation (HSCT)).
The most commonly used is the 3+7 regimen. In 2018, our center conducted a retrospective analysis of 242 newly diagnosed AML patients treated with the standard IA regimen, evaluating its efficacy and adverse reactions, and conducting prognostic factor analysis. The study results showed that the CR rate of one course of IA regimen induction therapy was 81.28%; after repeated induction therapy, the CR rate reached 92.34%, confirming that the IA regimen induction therapy has a high CR rate, consistent with many literature reports.
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.
Currently, preclinical studies have confirmed that the combination of idarubicin and cytarabine with venetoclax has a synergistic effect in the anti-tumor treatment of AML. Based on this, the CAVEAT study included 51 newly diagnosed primary or secondary AML patients aged ≥65 years who had not previously received intensive therapy (including AML patients with monosomal karyotype aged ≥60 years). The median age of the patients was 72 years. The treatment regimen for induction and consolidation therapy included idarubicin, cytarabine, and venetoclax (with reduced intensity for idarubicin and cytarabine). The overall response rate (ORR) was 72%, and the median overall survival (OS) was 11.2 months. Compared to secondary AML, patients with primary AML had a longer median OS (31.3 months vs 6.1 months). The most common non-hematologic adverse reactions included febrile neutropenia (55%), sepsis (35%), and diarrhea (35%). These studies suggest that the combination of idarubicin, cytarabine, and venetoclax is safe and tolerable in elderly fit AML patients, and can provide higher remission rates and longer survival. The results of this study also partly confirm the safety of venetoclax in combination with cytarabine and idarubicin for induction chemotherapy in elderly AML patients.
Given the favorable response rates and survival benefits achieved with the combination of VEN and IA in elderly patients with primary AML, we plan to design a prospective, single-arm, multicenter exploratory clinical trial to determine the efficacy and safety of the IA-based induction regimen combined with VEN (IAV regimen) followed by consolidation therapy with intermediate-dose cytarabine and venetoclax in newly diagnosed adult AML patients. This trial aims to provide evidence-based support for novel induction and consolidation treatment strategies for this patient population.
In this study, we also plan to evaluate the efficacy and safety of the combination of idarubicin, cytarabine, and venetoclax as induction therapy followed by consolidation therapy with intermediate-dose cytarabine and venetoclax in newly diagnosed adult AML patients. The aim is to provide a safer and more effective treatment option for these patients.
After signing the informed consent form, young newly diagnosed/eligible AML patients for intensive therapy will undergo various examinations as specified during the screening period. All eligible participants who do not meet the exclusion criteria should be followed up at baseline and on days 1, 3, 5, 7, 9, 11, 13, 15, and 21 during the induction treatment phase, and on days 1 and 21 of each cycle during the consolidation treatment phase. Follow-up visits should also be conducted at the time of withdrawal from the study or at the end of the study for assessment and monitoring.
After signing the informed consent form, young newly diagnosed/fit for intensive therapy AML patients will undergo screening and various tests as specified during the screening period. All eligible participants who do not meet the exclusion criteria will be assessed at baseline and at days 1, 3, 5, 7, 9, 11, 13, 15, and 21 during the induction therapy phase, and on the first and twenty-first day of each cycle during the consolidation therapy phase. Follow-up visits will be conducted at the time of withdrawal/study completion.
Specific treatment plan:
Induction therapy:
Venetoclax: 100mg on day 1, 200mg on day 2, 400mg on days 3-8; oral administration.Idarubicin: 10-12mg/m2 on days 1-3; intravenous infusion.Cytarabine: 100mg/m2 on days 1-7; intravenous infusion or subcutaneous injection.
Consolidation therapy after remission:
Venetoclax: 400mg on days 1-7; oral administration.Cytarabine: 2g/m2 every 12 hours on days 1-3; intravenous infusion.Four cycles in total.Patients who meet the criteria for autologous stem cell transplantation (ASCT) during the treatment process can undergo ASCT.Patients who meet the transplantation criteria and have a suitable donor can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Induction therapy and consolidation therapy after remission | Experimental | Drug: Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;, Drug: Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;, Other: utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).Induction therapy:Venetoclax + idarubicin + cytarabine Consolidation therapy after remission:Venetoclax + cytarabineIf The patient meets the criteria for autologous hematopoietic stem cell transplantation (ASCT) during the treatment process, they can undergo ASCT.If the patient meets the criteria for transplantation and there is a suitable donor, they can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Newly diagnosed primary AML patients. Diagnostic criteria refer to the 2022 WHO classification.
- Age between 18 and 60 years old.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 (see Appendix 2).
- Cardiac ultrasound LVEF ≥ 45%.
- Creatinine clearance ≥ 50 mL/min (calculated using the Cockcroft-Gault formula or measured using a 24-hour urine sample).
Key exclusion criteria (10 listed)
- Acute promyelocytic leukemia (APL).
- Relapsed/refractory AML patients.
- AML patients with known involvement of the central nervous system (CNS).
- Known HIV-infected participants (due to potential drug-drug interactions between antiretroviral drugs and venetoclax). HIV testing will be conducted during screening according to local guidelines or institutional standards.Participants with positive hepatitis B virus (HBV) or hepatitis C virus (HCV) infection. Non-active carriers of viral hepatitis or participants with low viral hepatitis viral titers after receiving non-prohibited antiviral therapy will not be excluded.
- Participants who have received strong or moderate CYP3A inducers/inhibitors therapy within 7 days prior to starting study treatment.
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 |
|---|---|---|
| Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;Also: Idarubicin (Idarubicin): 10-12mg/m2 on days 1 to 3; intravenous infusion, ;Cytarabine (Cytarabine): 100mg/m2 on days 1 to 7; intravenous infusion or subcutaneous injection.Induction Phase Regimen | Drug | Induction therapy and consolidation therapy after remission |
| Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration;Also: Cytarabine: 2g/m2 every 12 hours on day 1 to day 3; intravenous infusion;Consolidation therapy after remission | Drug | Induction therapy and consolidation therapy after remission |
| utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT).Four cycles in total.Patients who meet the criteria for autologous stem cell transplantation (ASCT) during the treatment process can undergo ASCT.Patients who meet the transplantation criteria and have a suitable donor can undergo allogeneic hematopoietic stem cell transplantation (allo-HSCT). | Other | Induction therapy and consolidation therapy after remission |
Primary outcome
The composite complete remission rate (CR+CRi)
Time frame: Four months from the start of initial induction therapy.
Composite complete remission rate: the proportion of patients who achieve complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) at the end of induction therapy (CR+CRi).• CR is defined as meeting all of the following criteria: ① bone marrow blasts <5%, no circulating or Auer rod blasts; ② no extramedullary disease; ③ ANC ≥1.0 × 109 /L; ④ platelet count ≥100 × 109 /L.• CRi is defined as PLT ≤100 × 109 /L and/or ANC ≤1.0 × 109 /L, with other criteria for CR being met.
1 secondary outcome
The incidence of hematological adverse reactions during induction therapy
Time frame: Four months from the start of initial induction therapy.
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 31 Jan 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Venetoclax : 100mg on day 1, 200mg on day 2, 400mg on days 3 to 8; oral administration;, Venetoclax (Venetoclax): 400mg on day 1 to day 7; oral administration; and utologous stem cell transplantation (ASCT) /allogeneic hematopoietic stem cell transplantation (allo-HSCT). 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 7 inclusion and 10 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 31 Jan 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 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?
The composite complete remission rate (CR+CRi) (time frame: Four months from the start of initial induction therapy.). 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 31 Jan 2024.