Acute Myeloid LeukemiaNCT05053425
Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated AML
A study testing Venetoclax, Azacitidine and Cladribine in people with Acute Myeloid Leukemia, run by LanZhou University at 1 site in China.
Trial summary
In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Venetoclax, Azacitidine and Cladribine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Oct 2021to 18 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The elderly patients(≥ 60) with AML diagnosed according to WHO criteria;
- Participants are ineligible for induction regimen;
- The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;
- The patients and their families agree and sign the informed consent form.
Who cannot join
- Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs);
- Infiltration of the central nervous system;
- Drugs use history affecting CYP3A within 7 days before enrollment;
- participants considered by the investigator to be unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Long Zhao
Lanzhou, Gansu, 730000
Long Zhao, +18919128021, zhaodragon@126.com
Qiushan Li, +8613893690080, ldyylwh@126.com
About this study
Official title: Clinical Study of Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated Acute Myeloid Leukemia
In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Overall survival (OS), complete remission rate/complete remission with incomplete recovery of blood cell count (CR/ CRi) were used as the primary endpoints, and time to response (TTR), duration of response (DOR), mortality, and recurrence rate were used as secondary endpoints,and the incidence of adverse events were evaluated.
Read the detailed description
Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.
regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2, the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Venetoclax, Azacitidine, Cladribine, Cytarabine, Idarubicin
- Keywords
- Acute Myeloid Leukemia, Bcl-2 Inhibitors, Azacytidine, Chemotherapy
- 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.
VenetoclaxDrug
Also called ABT-199
given po.
AzacitidineDrug
Also called 5-Azacytidine
given sc.
CladribineDrug
Also called 2-CdA
given ivgtt.
CytarabineDrug
Also called Ara-c
given sc or ivgtt.
IdarubicinDrug
Also called Idamycin®
given ivgtt.
| Study group | Role | What they receive |
|---|---|---|
| Venetoclax group | Experimental | Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc.
Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.
regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2,the reduction of regimen IA(cytarabine+idarubicin)was 5+2.
Maintenance therapy: azacytidine 75mg/m2, d1-7, sc. Receives: Drug: Venetoclax; Drug: Azacitidine; Drug: Cladribine; Drug: Cytarabine; Drug: Idarubicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival (OS)
Overall survival will be defined as the number of days from the date of first dose to the date of death.
Measured: up to 16 months.
CR/CRi
To assess the percentage of patients achieving CR/CRi according to the International Working Group criteria for AML.
Measured: up to 16 months.
Secondary outcomes (5)
Time to response
To assess the percentage of patients achieving CR/CRi or partial remission (PR) according to the International Working Group criteria for AML.
Measured: up to 16 months.
Duration of response
Duration of response will be defined as the number of days from the date of first response per the IWG criteria for AML to the earliest recurrence or progressive disease.
Measured: up to 16 months.
Mortality
The proportion of patients from enrollment to death was recorded.
Measured: up to 16 months.
Recurrence rate
Record the proportion of patients with recurrence in the study.
Measured: up to 16 months.
Adverse events
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Measured: Adverse events were assessed weekly during the first and second cycles, and every two cycles thereafter (each cycle is 28 days), up to 16 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2021
- Study start20 Oct 2021
- Primary completion18 Jan 2023 (estimated)
- Study completion18 Mar 2023 (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.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LanZhou University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Long Zhao, LanZhou University
- Investigators
- Long Zhao, M.M., Principal investigator, The First Hospital of Lanzhou University,Lanzhou,Gansu,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05053425
- Sponsor's protocol ID
- CSBCL2
- Other IDs
- ChiCTR2100045330
- Status last verified
- Apr 2022
- First submitted
- 16 Sep 2021
- Last updated
- 26 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Bcl-2 Inhibitors Combined With Azacytidine and Chemotherapy in Elderly Patients With Previously Untreated Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05053425
- Acronym / sponsor ID
- CSBCL2
- Conditions
- Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, Bcl-2 Inhibitors, Azacytidine, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- LanZhou UniversityUniversity, hospital or other
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 18 Jan 2023 (estimated)
- Study completion
- 18 Mar 2023 (estimated)
- First posted
- 22 Sep 2021 (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.
In this prospective study, 30 newly untreated elderly patients with acute myeloid leukemia(AML) who were not suitable for standard chemotherapy were enrolled to observe the efficacy and side effects of venetoclax (VEN) combined with azacytidine (AZA) and chemotherapy in newly treated elderly patients with AML. Overall survival (OS), complete remission rate/complete remission with incomplete recovery of blood cell count (CR/ CRi) were used as the primary endpoints, and time to response (TTR), duration of response (DOR), mortality, and recurrence rate were used as secondary endpoints,and the incidence of adverse events were evaluated.
Detailed description
Induction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative.
regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2, the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Venetoclax group | Experimental | Drug: Venetoclax, Drug: Azacitidine, Drug: Cladribine, Drug: Cytarabine, Drug: IdarubicinInduction therapy: venetoclax d1 100mg, d2 200mg, d3-28 400mg, po; azacytidine 75mg/m2, d1-7, sc. Consolidation therapy: Regimen A or B was chosen according to the wishes of the patients. In addition, venetoclax was used for 14 days for positive minimal residual disease(MRD) and 7 days for MRD negative. regimen A: the first two cycles: venetoclax 400mg, d1-7/14, po; cladribine 5mg/m2, d1-3, ivgtt; cytarabine 10mg/m2, q12h, d1-10, sc; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; regimen B: the first two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 100mg/m2, d1-5/7, ivgtt; idarubicin 8mg/m2, d1-2/3, ivgtt; the last two cycles: venetoclax 400mg, d1-7/14, po; cytarabine 0.5-1.0g/m2, d1-3, ivgtt; If the patient's ECOG performance status ≥2,the reduction of regimen IA(cytarabine+idarubicin)was 5+2. Maintenance therapy: azacytidine 75mg/m2, d1-7, sc. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The elderly patients(≥ 60) with AML diagnosed according to WHO criteria;
- Participants are ineligible for induction regimen;
- The Eastern Cooperative Oncology Group (ECOG) performance status is 0-3;
- The patients and their families agree and sign the informed consent form.
Key exclusion criteria (4 listed)
- Previous treatment for AML (including hypomethylating agents and other chemotherapy drugs);
- Infiltration of the central nervous system;
- Drugs use history affecting CYP3A within 7 days before enrollment;
- participants considered by the investigator to be unsuitable for inclusion.
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 |
|---|---|---|
| VenetoclaxAlso: ABT-199given po. | Drug | Venetoclax group |
| AzacitidineAlso: 5-Azacytidinegiven sc. | Drug | Venetoclax group |
| CladribineAlso: 2-CdAgiven ivgtt. | Drug | Venetoclax group |
| CytarabineAlso: Ara-cgiven sc or ivgtt. | Drug | Venetoclax group |
| IdarubicinAlso: Idamycin®given ivgtt. | Drug | Venetoclax group |
Primary outcome
Overall survival (OS)
Time frame: up to 16 months.
Overall survival will be defined as the number of days from the date of first dose to the date of death.
CR/CRi
Time frame: up to 16 months.
To assess the percentage of patients achieving CR/CRi according to the International Working Group criteria for AML.
5 secondary outcomes
Time to response
Time frame: up to 16 months.
Duration of response
Time frame: up to 16 months.
Mortality
Time frame: up to 16 months.
Recurrence rate
Time frame: up to 16 months.
Adverse events
Time frame: Adverse events were assessed weekly during the first and second cycles, and every two cycles thereafter (each cycle is 28 days), up to 16 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2022.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Long Zhao, M.M. principal investigator
The First Hospital of Lanzhou University,Lanzhou,Gansu,China
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, Azacitidine and Cladribine in people with Acute Myeloid Leukemia, run by LanZhou 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 26 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Long Zhao, M.M. (+18919128021, zhaodragon@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival (OS) (time frame: up to 16 months.). 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 26 Apr 2022.