Chronic Myeloid LeukemiaNCT06390306

The Efficacy and Safety of Third-generation TKIs Combined With Azacitidine and Bcl-2 Inhibitor in Patients With CML-MBP

An observational study of Chronic Myeloid Leukemia, run by Peking University People's Hospital at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Trial summary

This is a prospective multi-center study to investigate efficacy and safety of the third generation tyrosine kinase inhibitors (TKIs) combined with azacitidine and B-cell lymphoma-2 (Bcl-2) inhibitor in patients with myeloid blast phase chronic myeloid leukemia (CML-MBP). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Myeloid Leukemia
What is being tested?: Ponatinib, Azacitidine and Venetoclax
Type of treatment: Pill or oral medicine, Injection or infusion
How many people: 30 participants
Where: 15 sitesChina
Study dates: 1 Jul 2024to 1 Dec 2027
How long will I take part?: 3 Years
Phase: Observational
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 years and older
All sexes
Adult, Older adult

Study population: Peking universuty people's hospital Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Henan Cancer Hospital The First Affiliated Hospital, Zhejiang University School of Medicine Chinese Academy of Medical Sciences \& Peking Union Medical College Hospital Nanfang Hospital, Southern Medical University Chuiyangliu hospital affiliated to tsinghua university The First Affiliated Hospital of Nanjing Medical University Qilu Hospital of Shandong University Xi'an International Medical Center Hospital Nanyang Central Hospital Ningbo Medical Center Lihuili Hospital Beijing Lu Daopei Hospital Sichuan Provincial People's Hospital The First Affiliated Hospital of Kunming Medical University The First Affiliated Hospital of Guangxi Medical University

Who may be able to join

age ≥ 18 years old;
philadelphia chromosome (Ph)-positive or BCR::ABL-positive;
serum creatinine ≤ 1.5 × upper limit of normal (ULN) or 24h creatinine clearance ≥ 50 mL/min when serum creatinine was \> 1.5 × ULN;
serum total bilirubin ≤ 1.5 × ULN;
aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN;
amylase ≤ 1.5 × ULN; (7) lipase ≤ 1.5 × ULN;
ejection fraction \> 50%; corrected QT interval on electrocardiographic evaluation was ≤ 450 ms in men or ≤ 470 ms in women.

Who cannot join

concurrent diseases requiring treatment(s) with potential to interact with 3G-TKI;
diagnosis of other primary malignancies;
history of allogeneic HSCT;
extramedullary disease only.

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qian Jiang, MD contact

+861088326006

jiangqian@medmail.com.cn

City, postcode or hospital

Sites recruiting now only

15 sites in 1 country

China15 sites, 15 recruiting

Peking university people's hospital
Beijing, Beijing Municipality, 100044
Cuicui Cong Peking university people's hospital, +861088324516, rmyyllwyh@163.com
Qian Jiang, MD
Recruiting
Beijing Lu Daopei Hospital
Beijing
Qiang Fu, +8601050959755, FUQIANG003744@sohu.com
Recruiting
Chuiyangliu hospital affiliated to tsinghua university
Beijing
Fang Ye, +8601067700622, yefang2006369@163.com
Not yet recruiting
Sichuan Provincial People's Hospital
Chengdu
Xiaodong Wang, +8602887394103, wxd621025@162.com
Not yet recruiting
Nanfang Hospital, Southern Medical University
Guangdong
Na Xu, +8602061641888, sprenaa@163.com
Not yet recruiting
The First Affiliated Hospital of Kunming Medical University
Kunming
mingxia shi, +86087165324888, shmxia2002@sina.com
Not yet recruiting
The First Affiliated Hospital of Nanjing Medical University
Nanjing
Yu Zhu, +8602583714511, zhuyu@jsph.org.cn
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning
Zhenfang Liu, +8607715359339, liuzhenfang@gxmu.edu.cn
Recruiting
Nanyang Central Hospital
Nanyang
Lijuan Duan, +86037763200010, doctor681@163.com
Recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo
Jing Le, +86057455835583, nblejing@aliyun.com
Recruiting
Qilu Hospital of Shandong University
Qilu
Cunyan Chen, +86053182169114, chency@sdu.edu.cn
Not yet recruiting
Chinese Academy of Medical Sciences & Peking Union Medical College Hospital
Tianjin
Bingcheng Liu, +8602223909999, liubingcheng@ihcams.ac.cn
Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Henan Cancer Hospital
Wuhan
Weimin Li, +8602785726114, lee937@126.com
Not yet recruiting
Xi'an International Medical Center Hospital
Xi'an
Guohui Li, +8602902996999, lghab@126.com
Recruiting
The First Affiliated Hospital, Zhejiang University School of Medicine
Zhejiang
Jian Huang, +86057187236114, househuang@zju.edu.cn
Recruiting

Other trials in China

About this study

Official title: The Efficacy and Safety of Third Generation Tyrosine Kinase Inhibitors Combined With Azacitidine and B-cell Lymphoma-2 Inhibitor in Patients With Myeloid Blast Phase Chronic Myeloid Leukemia

Read the detailed description

CML-MBP has dismal outcome. Currently, there is no standardized induction treatment approach in CML-MBP. The European LeukemiaNet (ELN) recommendations and NCCN guideline recommended the combination of TKI and chemotherapy in CML-MBP. The previous study revealed that TKI combined with hypomethylating agents had promising efficacy. However, imatinib and second generation TKI are the most widely applied in combination treatment, there is limited data in third generation TKI.

Currently, venetoclax in combination with hypomethylating agents such as azacitidine is standard treatment for patients with AML unsuitable for intensive induction chemotherapy. Maiti et al. reported that TKI combined with venetoclax and detectable had promising efficacy in CML-MBP. Therefore, the investigator conducted a study to explore the efficacy and safety of a third generation TKI in combination with azacitidine and Bcl-2 inhibitor in CML-MBP and multi-omics exploratory analysis was performed to identify potential biomarkers correlated with the outcome.

Conditions: Chronic Myeloid Leukemia
Being tested: Ponatinib, Azacitidine, Venetoclax, Olverembatinib
Medical subject headings: Leukemia, Myelogenous, Chronic, BCR-ABL Positive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PonatinibDrug
Ponatinib is recommended orally (PO) daily continuously on days 1-28 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.
AzacitidineDrug
Azacitidine is recommended 75mg/m2 subcutaneously on days 1-7 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.
VenetoclaxDrug
Venetoclax is recommended orally (PO) daily on days 1-14 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.
OlverembatinibDrug
Olverembatinib is recommended orally (PO) every other day on days 1-28 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.

Study groups in NCT06390306
Study group	Role	What they receive
3G-TKI + AZA + Ven group		Adult CML-MBP Receives: Drug: Ponatinib; Drug: Azacitidine; Drug: Venetoclax; Drug: Olverembatinib

What is being measured

The primary outcome is the main question the study is designed to answer.

Major hematologic response (MaHR)
either a complete hematologic response (CHR) or no evidence of leukemia (NEL).
Measured: At the end of Cycle 2 (each cycle is 28 days)

Secondary outcomes (8)

Return to chronic phase
< 10% blasts in blood and bone marrow with no extra-medullary leukemia and last for ≥ 4 weeks
Measured: At the end of Cycle 2 (each cycle is 28 days)
Major cytogenetic response (MCyR)
Ph-positive cells ≤ 35%
Measured: Up to 3 years
Complete cytogenetic response (CCyR)
no Ph-positive cell
Measured: Up to 3 years
Major molecular response (MMR)
BCR::ABL1IS ≤ 0.1%
Measured: Up to 3 years
Event-free survival (EFS)
interval from therapy start to lacking RCP after 1 cycle, MaHR after 2 cycles, loss of hematologic response, progression to blast phase again, or death from any causes
Measured: Up to 3 years
CML-related survival
interval from therapy start to death from blast phase, or censored at the last follow-up
Measured: Up to 3 years
Survival
interval from therapy start to death from any cause or censored at the last follow-up
Measured: Up to 3 years
Incidence of adverse events
Adverse effects (AEs) were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0. and assessed continuously.
Measured: Up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jul 20241 Dec 2027

First posted30 Apr 2024
Study start1 Jul 2024
Primary completion1 Dec 2026 (estimated)
Study completion1 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic 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: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 30 participants (estimated)
Target duration: 3 Years

IDs, dates and publications

ClinicalTrials.gov ID: NCT06390306
Sponsor's protocol ID: 2023PHB323-002
Status last verified: May 2025
First submitted: 18 Apr 2024
Last updated: 3 Jun 2025
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Qian Jiang, MD

+861088326006

jiangqian@medmail.com.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Chronic Myeloid Leukemia trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Efficacy and Safety of Third Generation Tyrosine Kinase Inhibitors Combined With Azacitidine and B-cell Lymphoma-2 Inhibitor in Patients With Myeloid Blast Phase Chronic Myeloid Leukemia
ClinicalTrials.gov ID: NCT06390306
Acronym / sponsor ID: 2023PHB323-002
Conditions: Chronic Myeloid Leukemia
Study type: Observational
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: Peking University People's HospitalUniversity, hospital or other
Collaborators: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Henan Cancer Hospital, First Affiliated Hospital of Zhejiang University, Peking Union Medical College, Nanfang Hospital, Southern Medical University, Beijing Chuiyangliu Hospital
Study start: 1 Jul 2024 (actual)
Primary completion: 1 Dec 2026 (estimated)
Study completion: 1 Dec 2027 (estimated)
First posted: 30 Apr 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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 3 Years
Number of arms: 1

Arm	Type	Receives
3G-TKI + AZA + Ven group	–	Drug: Ponatinib, Drug: Azacitidine, Drug: Venetoclax, Drug: OlverembatinibAdult CML-MBP

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: Peking universuty people's hospital Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Henan Cancer Hospital The First Affiliated Hospital, Zhejiang University School of Medicine Chinese Academy of Medical Sciences \& Peking Union Medical College Hospital Nanfang Hospital, Southern Medical University Chuiyangliu hospital affiliated to tsinghua university The First Affiliated Hospital of Nanjing Medical University Qilu Hospital of Shandong University Xi'an International Medical Center Hospital Nanyang Central Hospital Ningbo Medical Center Lihuili Hospital Beijing Lu Daopei Hospital Sichuan Provincial People's Hospital The First Affiliated Hospital of Kunming Medical University The First Affiliated Hospital of Guangxi Medical University

Key inclusion criteria (7 listed)

age ≥ 18 years old;
philadelphia chromosome (Ph)-positive or BCR::ABL-positive;
serum creatinine ≤ 1.5 × upper limit of normal (ULN) or 24h creatinine clearance ≥ 50 mL/min when serum creatinine was \> 1.5 × ULN;
serum total bilirubin ≤ 1.5 × ULN;
aspartate aminotransferase and alanine aminotransferase ≤ 2.5 × ULN;

Key exclusion criteria (4 listed)

concurrent diseases requiring treatment(s) with potential to interact with 3G-TKI;
diagnosis of other primary malignancies;
history of allogeneic HSCT;
extramedullary disease only.

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
PonatinibPonatinib is recommended orally (PO) daily continuously on days 1-28 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.	Drug	3G-TKI + AZA + Ven group
AzacitidineAzacitidine is recommended 75mg/m2 subcutaneously on days 1-7 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.	Drug	3G-TKI + AZA + Ven group
VenetoclaxVenetoclax is recommended orally (PO) daily on days 1-14 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.	Drug	3G-TKI + AZA + Ven group
OlverembatinibOlverembatinib is recommended orally (PO) every other day on days 1-28 in 28-day cycle. Treatment repeats every 28 days in the absence of disease progression, unacceptable toxicity or HSCT.	Drug	3G-TKI + AZA + Ven group

Primary outcome

Major hematologic response (MaHR)
Time frame: At the end of Cycle 2 (each cycle is 28 days)
either a complete hematologic response (CHR) or no evidence of leukemia (NEL).

8 secondary outcomes

Return to chronic phase
Time frame: At the end of Cycle 2 (each cycle is 28 days)
Major cytogenetic response (MCyR)
Time frame: Up to 3 years
Complete cytogenetic response (CCyR)
Time frame: Up to 3 years
Major molecular response (MMR)
Time frame: Up to 3 years
Event-free survival (EFS)
Time frame: Up to 3 years
CML-related survival
Time frame: Up to 3 years
Survival
Time frame: Up to 3 years
Incidence of adverse events
Time frame: Up to 3 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 3 Jun 2025.
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.

Qian Jiang, MD contact

+861088326006

jiangqian@medmail.com.cn

Qian Jiang, MD principal investigator

Peking University People's Hospital

15 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Myeloid Leukemia, run by Peking University People's Hospital at 15 sites 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 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: looking for participants now, as of the sponsor's last update on 3 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites 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 Qian Jiang, MD (+861088326006, jiangqian@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major hematologic response (MaHR) (time frame: At the end of Cycle 2 (each cycle is 28 days)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06390306.

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 3 Jun 2025.