AML, AdultNCT06841952
Study of Tretinoin Capsules in Combination With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
A study testing ATRA+Venetoclax+Azacitidine and Chemotherapy drug in people with AML, Adult, run by The First Affiliated Hospital of Soochow University at 1 site in China.
Trial summary
This study was a prospective, two-arm, multicenter clinical trial to evaluate the efficacy and safety of tretinoin capsules combined with azacitidine and venetoclax in the treatment of newly diagnosed acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- AML, Adult
- What is being tested?
- ATRA+Venetoclax+Azacitidine and Chemotherapy drug
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteChina
- Study dates
- 15 Feb 2025to 15 Dec 2030
- 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
- Patients initially diagnosed with AML (excluding APL) according to WHO diagnostic criteria.
- Patients who have not previously received other induction therapies (excluding hydroxyurea and leukapheresis).
- Total white blood cell (WBC) count ≤ 25 × 10^9/L.
- Ages 18 to 60 years, inclusive, with no gender restrictions.
- ECOG Performance Status score of 0-2.
- Total bilirubin ≤ 3 times the upper limit of normal (ULN); Alanine aminotransferase (ALT) ≤ 3 times ULN; Aspartate aminotransferase (AST) ≤ 3 times ULN; (excluding leukemia infiltration).
- Endogenous creatinine clearance rate ≥ 30 ml/min.
- Enrolled patients must be capable of understanding and willing to participate in the study, and must sign the informed consent form.
Who cannot join
- Patients with Acute Promyelocytic Leukemia (APL).
- Patients with concomitant central nervous system leukemia or extramedullary leukemia involvement, such as testicular infiltration.
- Patients with current or historical immunodeficiency virus infection.
- Patients with active Hepatitis B or Hepatitis C infection.
- Patients with a history of drug allergy, including but not limited to etoposide, azacitidine, venetoclax, daunorubicin, and cytarabine.
- Patients with active or progressive malignant tumors or severe infections.
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- Patients with a left ventricular ejection fraction (LVEF) of less than 30%, classified as New York Heart Association (NYHA) Class III or above, and those deemed ineligible for enrollment by the investigator.
- Patients who are pregnant or breastfeeding.
- Patients who refuse to participate in the study.
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
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu
Xiang Zhang, 86+0512-67781856, zhuxiaomin@suda.edu.cn
About this study
Official title: A Prospective, Two-arm, Multi-center Clinical Study of the Efficacy and Safety of Tretinoin Capsules Combined With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
This study was a prospective, two-arm, multicenter clinical trial to evaluate the efficacy and safety of tretinoin capsules combined with azacitidine and venetoclax in the treatment of newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax, and tretinoin may arrest cancer cell growth by demethylation, promoting cell differentiation, or killing cells, while reducing blood-related adverse effects by promoting cell differentiation.
Read the detailed description
This is a multi-center, non-controlled, open-label, Phase 3 interventional study.Young (≥18 and ≤60 years old) patients with newly diagnosed non M3, acute myeloid leukemia will receive a combination of AZA+Venetoclax+ATRA(AVA regimen) or daunorubicin +cytarabine(DA regimen) as induction treatment for 2 cycles.
According to standard procedures, patients will receive one of the following consolidation regimens separately, including the AVA regimen, or medium-dose cytarabine alone or in combination with anthracyclines regimen for 2cycle. After consolidation therapy, maintenance treatment could be given once a month for 4 times, then once every 3 months until progression.
After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors.
The primary endpoint is ORR after second induction therapy.Outcome measures included complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) .
- Conditions
- AML, Adult
- Being tested
- ATRA+Venetoclax+Azacitidine, Chemotherapy drug
- Keywords
- tretinoin, azacitidine, venetoclax
- 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.
ATRA+Venetoclax+AzacitidineDrug
Participants will receive a standard dose of azacitidine (75mg/m²/day)，venetoclax (target dose, 400 mg)，ATRA 45mg/m²/day
Chemotherapy drugDrug
Participants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin).
| Study group | Role | What they receive |
|---|---|---|
| ATRA+VEN+AZA arm | Experimental | (1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 1 , 200mg orally for day 2, 300mg orally for day3-5, 400mg orally for day6-9,ATRA capsule 45mg/m² orally for day 11-28, every 28 days for 2 cycles or progression; (2)Consolidate therapy:AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 1 , 200mg orally for day 2, 300mg orally for day3-5, 400mg orally for day6-9,ATRA capsule 45mg/m² orally for day 11-28, every 28 days for 2 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 orally for d1-21 every 28 days,AZA 75mg/m² per day for days 1-7.Maintenance treatment was given once a month for 4 times, then once every 3 months until progression.
After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors. Receives: Drug: ATRA+Venetoclax+Azacitidine |
| DNR+ Ara-C arm | Active comparator | (1)Inductive therapy: Daunorubicin 60mg/m² d1-3，cytarabine100mg/m² d1-7, every 28 days for 2 cycles or progression; (2)Consolidate therapy:Intermediate-dose cytarabine alone or combined with anthracyclines is recommended (cytarabine 1.5-2g/m²), every 28 days for 2 cycles or till progression. (3) Maintenance therapy:AZA 75mg/m² per day for days 1-7 every 28 days.Maintenance treatment was given once a month for 4 times, then once every 3 months until progression.
After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors. Receives: Drug: Chemotherapy drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
The overall response rate (ORR) after the second therapy
ORR rate was defifined as patients achieving a CRc or PR
Measured: Efficacy was assessed within 2 weeks after completion of the second course of therapy or within 1 week before the third course of therapy
The composite complete remission rate (CRc) after the second therapy
complete response (CR) plus complete response with incomplete blood count recovery (CRi)] after 2 cycles of treatment.
Measured: Efficacy was assessed within 2 weeks after completion of the second course of therapy or within 1 week before the third course of therapy
Secondary outcomes (4)
Composite complete response (CRc) after the first therapy
CRc rate was defifined as patients achieving a CR or CRi
Measured: Efficacy was assessed within 2 weeks after completion of the first course of induction therapy or within 1 week before the second course of therapy
The overall response rate (ORR) after the first therapy
ORR rate was defifined as patients achieving a CRc or PR
Measured: Efficacy was assessed within 2 weeks after completion of the first course of induction therapy or within 1 week before the second course of therapy
Rate of transfusion independence
Rate of transfusion independence (TI) , including platelet transfusion independence rate and red blood cell transfusion independence rate.
Measured: Up to 28 days after the start of therapy
Overall Survival (OS)
(OS) refers to the length of time from randomization until the death of the patient from any cause.
Measured: up to 2 years after the date of the last enrolled participants
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start15 Feb 2025 (estimated)
- Primary completion15 Dec 2028 (estimated)
- Study completion15 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML, AdultStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Soochow 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, HAN Yue, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841952
- Sponsor's protocol ID
- SOOCHOW-HY-2024-12-10
- Status last verified
- Feb 2025
- First submitted
- 15 Jan 2025
- Last updated
- 24 Feb 2025
- Results posted
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Two-arm, Multi-center Clinical Study of the Efficacy and Safety of Tretinoin Capsules Combined With Azacitidine and Venetoclax in Treatment Naïve Participants With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06841952
- Acronym / sponsor ID
- SOOCHOW-HY-2024-12-10
- Conditions
- AML, Adult
- Keywords
- tretinoin, azacitidine, venetoclax
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Soochow UniversityUniversity, hospital or other
- Study start
- 15 Feb 2025 (estimated)
- Primary completion
- 15 Dec 2028 (estimated)
- Study completion
- 15 Dec 2030 (estimated)
- First posted
- 24 Feb 2025 (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 was a prospective, two-arm, multicenter clinical trial to evaluate the efficacy and safety of tretinoin capsules combined with azacitidine and venetoclax in the treatment of newly diagnosed acute myeloid leukemia. Azacitidine, venetoclax, and tretinoin may arrest cancer cell growth by demethylation, promoting cell differentiation, or killing cells, while reducing blood-related adverse effects by promoting cell differentiation.
Detailed description
This is a multi-center, non-controlled, open-label, Phase 3 interventional study.Young (≥18 and ≤60 years old) patients with newly diagnosed non M3, acute myeloid leukemia will receive a combination of AZA+Venetoclax+ATRA(AVA regimen) or daunorubicin +cytarabine(DA regimen) as induction treatment for 2 cycles.
According to standard procedures, patients will receive one of the following consolidation regimens separately, including the AVA regimen, or medium-dose cytarabine alone or in combination with anthracyclines regimen for 2cycle. After consolidation therapy, maintenance treatment could be given once a month for 4 times, then once every 3 months until progression.
After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors.
The primary endpoint is ORR after second induction therapy.Outcome measures included complete remission (CR)/complete remission with incomplete hematologic recovery (CRi) .
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ATRA+VEN+AZA arm | Experimental | Drug: ATRA+Venetoclax+Azacitidine(1)Inductive therapy: AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 1 , 200mg orally for day 2, 300mg orally for day3-5, 400mg orally for day6-9,ATRA capsule 45mg/m² orally for day 11-28, every 28 days for 2 cycles or progression; (2)Consolidate therapy:AZA 75mg/m² per day for days 1-7 and venetoclax 100mg orally for day 1 , 200mg orally for day 2, 300mg orally for day3-5, 400mg orally for day6-9,ATRA capsule 45mg/m² orally for day 11-28, every 28 days for 2 cycles or progression; (3) Maintenance therapy:ATRA 45mg/m2 orally for d1-21 every 28 days,AZA 75mg/m² per day for days 1-7.Maintenance treatment was given once a month for 4 times, then once every 3 months until progression. After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors. |
| DNR+ Ara-C arm | Active comparator | Drug: Chemotherapy drug(1)Inductive therapy: Daunorubicin 60mg/m² d1-3，cytarabine100mg/m² d1-7, every 28 days for 2 cycles or progression; (2)Consolidate therapy:Intermediate-dose cytarabine alone or combined with anthracyclines is recommended (cytarabine 1.5-2g/m²), every 28 days for 2 cycles or till progression. (3) Maintenance therapy:AZA 75mg/m² per day for days 1-7 every 28 days.Maintenance treatment was given once a month for 4 times, then once every 3 months until progression. After the second induction therapy, allogeneic hematopoietic stem cell transplantation was recommended for patients with suitable donors. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Patients initially diagnosed with AML (excluding APL) according to WHO diagnostic criteria.
- Patients who have not previously received other induction therapies (excluding hydroxyurea and leukapheresis).
- Total white blood cell (WBC) count ≤ 25 × 10^9/L.
- Ages 18 to 60 years, inclusive, with no gender restrictions.
- ECOG Performance Status score of 0-2.
Key exclusion criteria (9 listed)
- Patients with Acute Promyelocytic Leukemia (APL).
- Patients with concomitant central nervous system leukemia or extramedullary leukemia involvement, such as testicular infiltration.
- Patients with current or historical immunodeficiency virus infection.
- Patients with active Hepatitis B or Hepatitis C infection.
- Patients with a history of drug allergy, including but not limited to etoposide, azacitidine, venetoclax, daunorubicin, and cytarabine.
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 |
|---|---|---|
| ATRA+Venetoclax+AzacitidineParticipants will receive a standard dose of azacitidine (75mg/m²/day)，venetoclax (target dose, 400 mg)，ATRA 45mg/m²/day | Drug | ATRA+VEN+AZA arm |
| Chemotherapy drugParticipants will receive commercially available cytarabine (cytosine arabinoside) and anthracycline (daunorubicin). | Drug | DNR+ Ara-C arm |
Primary outcome
The overall response rate (ORR) after the second therapy
Time frame: Efficacy was assessed within 2 weeks after completion of the second course of therapy or within 1 week before the third course of therapy
ORR rate was defifined as patients achieving a CRc or PR
The composite complete remission rate (CRc) after the second therapy
Time frame: Efficacy was assessed within 2 weeks after completion of the second course of therapy or within 1 week before the third course of therapy
complete response (CR) plus complete response with incomplete blood count recovery (CRi)] after 2 cycles of treatment.
4 secondary outcomes
Composite complete response (CRc) after the first therapy
Time frame: Efficacy was assessed within 2 weeks after completion of the first course of induction therapy or within 1 week before the second course of therapy
The overall response rate (ORR) after the first therapy
Time frame: Efficacy was assessed within 2 weeks after completion of the first course of induction therapy or within 1 week before the second course of therapy
Rate of transfusion independence
Time frame: Up to 28 days after the start of therapy
Overall Survival (OS)
Time frame: up to 2 years after the date of the last enrolled participants
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 24 Feb 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ATRA+Venetoclax+Azacitidine and Chemotherapy drug in people with AML, Adult, run by The First Affiliated Hospital of Soochow 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 8 inclusion and 9 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: opening soon, as of the sponsor's last update on 24 Feb 2025. 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 Yue Han (86+0512-67781856, hanyuesz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall response rate (ORR) after the second therapy (time frame: Efficacy was assessed within 2 weeks after completion of the second course of therapy or within 1 week before the third course of therapy). 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 24 Feb 2025.