Acute Myeloid LeukemiaPhase 1/2NCT06746519
BN104 in Combination With Chemotherapy or Targeted Agents for Acute Myeloid Leukemia
A Phase 1/2 study testing BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine in people with Acute Myeloid Leukemia, run by Chen Suning at 1 site in China.
Trial summary
The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- 25 Dec 2024to 30 Jun 2027
- Phase
- Phase 1/2
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have been fully informed about the study and have voluntarily signed the ICF;
- Patients with newly diagnosed primary AML according to the 2022 World Health Organization (WHO) criteria (Groups A and B) or patients with relapsed/refractory AML who have been previously treated with menin inhibitor monotherapy (Group C) and have an intermediate or poor prognosis according to the 2022 ELN Risk Stratification, as well as a defined combination of NPM1 mutation or NUP98 rearrangement or KMT2A rearrangement
- Peripheral blood leukocyte count ≤ 25 x 109/L (limited to patients enrolled in groups B and C, where hydroxyurea is allowed to control peripheral blood leukocyte count)
- Aged 18 years or older;
- ECOG (GroupA and B:0,1,2; GroupC:0,1,2,3)
- For patients in group B, unfit for intensive chemotherapy is defined as:≥75 years of age or;Age ≥18 years and age <75 years with any of the following co-morbidities;ECOG score of 2 or 3;Cardiac history: congestive heart failure requiring treatment, or ejection fraction ≤50%, or chronic stable angina;DLCO ≤ 65% or FEV1 ≤ 65%;Creatinine clearance ≥30 ml/min and <45 ml/min;Liver injury total bilirubin > 1.5 x ULN but ≤ 3 x ULN.
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- For patients in group C, previous failed treatment with menin inhibitors is required;
- adequate hepatic, renal, and cardiac function, as defined:Serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 x upper limit of normal range (ULN);Total bilirubin ≤ 1.5 x ULN* and in patients with Gilbert disease, total bilirubin ≤ 3 x ULN;Creatinine clearance ≥ 45 ml/min* as estimated by the Cockcroft-Gault formula (if <45 ml/min, enrollment is allowed if creatinine ≤ 130 µmol/L); Left ventricular ejection fraction ≥ 45%*; Note: In Phase II studies, ALT or AST may be relaxed to ≤5 x ULN if the investigator assesses that the elevated ALT or AST is due to leukemia invasion of the liver;For patients <75 years of age enrolled in Group B, total bilirubin ≤ 3 × ULN, creatinine clearance ≥ 30 ml/min, or left ventricular ejection fraction < 50% are allowed;
- for patients with D-dimer test result > 5×ULN in the screening period, relevant tests (e.g. review of coagulation function after a certain time interval, ultrasound of deep veins of the lower limbs, etc.) are required to exclude deep vein thrombosis, hypercoagulable state of blood and disseminated intravascular coagulation before enrollment;
- expected survival of more than 12 weeks as judged by the investigator;
- Be willing to attend study visits as required by the study protocol
- female patients of childbearing potential or male patients whose female partners are of childbearing potential must agree to use an effective method of contraception, such as a double-barrier method of contraception, condoms, oral or injectable contraceptives, and intrauterine devices (IUDs), for the duration of the study and within 30 days of the last study dose. Postmenopausal women (>45 years of age and menopause of more than 1 year) and surgically sterilized women are exempt from this condition.
Who cannot join
- have active central nervous system (CNS) leukemia;
- a known history of clinically significant liver disease, including viral or other hepatitis or cirrhosis:Positive hepatitis B surface antigen (HBsAg) serology requires a negative hepatitis B virus (HBV) DNA test for enrollment; For patients with hepatitis C virus (HCV) antibody serology positive, a negative HCV RNA test result is required for enrollment.
- known human immunodeficiency virus (HIV) infection;
- pregnant (positive screening pregnancy test) or lactating females;
- meet any of the following cardiac-related criteria:Hereditary long QT interval syndrome or QTcF > 450 msec;Various clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting within 6 months prior to enrollment, congestive heart failure graded by the New York Heart Association (NYHA) as grade 2 or higher (inclusive);
- the patient has suffered from other malignant tumors within the past 5 years, except for radically treated basal cell carcinoma of the skin, carcinoma in situ of the breast or carcinoma in situ of the cervix;
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- have received prior anti-leukemia therapy (for patients in Groups A and B), except for the following: use of hydroxyurea or leukocyte monocloning for control of white blood cell count, or treatment with all-trans retinoic acid due to initial suspicion of acute promyelocytic leukemia, or use of nondemethylating medications for the treatment of MDS
- for patients in Group C, prior anti-leukemia therapy, including chemotherapy, radiotherapy, hormonal therapy, targeted therapy, or immunotherapy, administered less than 2 weeks or 5 half-lives (whichever is shorter) prior to the start of study treatment; for patients who have undergone autologous hematopoietic stem cell transplantation or CAR-T therapy within 60 days prior to the start of study treatment, or have not recovered from toxicity associated with ASCT or CAR-T therapy Exclusion will be required for those who have had an allogeneic HSCT within 100 days prior to the start of study treatment, or if the patient still has a combination of active acute and chronic graft-versus-host disease, or if the patient still requires immunosuppressive therapy;
- pre-existing treatment with targeted menin (for Group A and B patients)
- pre-existing non-hematologic toxicities that have not returned to grade 0 or 1 (except alopecia areata);
- patients who have had a chest CT within 1 month prior to screening and suggestive of pulmonary nodules need to undergo T-SPOT (T-cell spotting test for tuberculosis infection) during the screening period, and those with positive results need to be excluded (no additional tests are required if no chest CT has been performed within 1 month prior to screening);
- uncontrolled active infection:Patients with non-serious infectious complications (e.g., oral Candida infection or uncomplicated urinary tract infection, etc.) for which oral/topical anti-infective therapy is being applied may be enrolled;Patients with severe infections requiring hospitalization or intravenous antibiotic therapy within 14 days prior to enrollment, patients with no evidence of infection, and patients receiving prophylactic anti-infective, antifungal, or antiviral therapy for prolonged neutropenia may be enrolled;Patients treated with intravenous antibiotics or hospitalized for febrile neutropenia, but no evidence of infectious etiology is found, and patients with a normal temperature for more than 72 hours without antipyretic medication may be enrolled;
- patients with known dysphagia, short bowel syndrome, gastroparesis, or other conditions that limit oral drug intake or gastrointestinal absorption;
- patients with a history of severe allergy to menin inhibitors or hypersensitivity to any component of BN104
- inadequate patient compliance with participation in this clinical study as judged by the investigator
- any other disease, metabolic abnormality, physical examination abnormality, or clinically significant laboratory test abnormality that, in the judgment of the investigator, gives reason to suspect that the patient has a disease or condition that is inappropriate for the use of the study medication, or that will interfere with the interpretation of the results of the study, or that places the patient at high risk.
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 of Soochow University
Suzhou, Jiangsu, 215000
Suning Chen, Doctor, 13814881746, chensuning@sina.com
Suning Chen, Doctor
About this study
Official title: A Phase I/II , Multicenter, Open Label Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of the Combination of the Menin Inhibitor BN104 for the Treatment of Patients With Acute Myeloid Leukemia
The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia.
Read the detailed description
The study is divided into 2 phases. Phase1 dose escalation part will enroll 90 patients to evaluate safety and tolerance of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloblastic leukemia with specific mutations (KMT2A gene rearrangement ,NPM1 gene mutation and NUP98 rearrangement). Patients will be allocated into 3 cohorts based on their disease status quo. Each cohort will use 3+3 dose escalation model, the starting dose level is 200mg of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine.
- Cohort A: Newly diagnosed AML patients with specific mutations who are suitable to receive BN104 combined with intensive chemotherapy(cytarabine with idarubicin or daunorubicin), which short as"7+3 induction regimen", consisting of remisson introdcution,consolidation and BN104 maintenance phase. Patients who achieve a complete remission (CR), complete remission with partial hematologic recovery (CRh), or complete remission with incomplete hematologic recovery (CRi) after 1 or 2 induction cycles may proceed on to consolidation therapy. Patients who do not achieve CR,CRh or CRi after 1 or 2 induction regimens will be considered a treatment failure and thus will be terminated from study treatment. Patients entering the consolidation phase then received an intravenous infusion of cytarabine 1-2 g/m2 every 12 hours (Q12H), using a total of 6 doses, which could be administered either consecutively at D1-3 or separately at D1, D3, and D5, depending on the study center's treatment routine. In each treatment cycle, the indicated dose of BN104 was given orally twice daily until the next cycle of consolidation treatment. Patients entering the consolidation phase receive at least 1 cycle of consolidation therapy and a maximum of 4 cycles.
After completion of consolidation therapy, patients who remain in CR, CRh, or CRi may continue to receive BN104 monotherapy maintenance therapy at the indicated dose administered twice daily for 1 cycle every 28 days until completion of 26 cycles of maintenance therapy, disease relapse/progression, receipt of hematopoietic stem cell transplantation, intolerable toxicity, loss to visit, withdrawal of informed consent, death, or other circumstances that, in the judgment of the investigator, require the termination of study drug, whichever occurs first.
- Cohort B: Newly diagnosed AML patients with specific mutations who are ≥75 years of age or <75 years of age but are not suitable for intensive chemotherapy due to co-morbidities. The regimen is BN104 taken twice daily combined with azacitidine and venetolax. Venetolax (100 mg, day 1; 200 mg, day 2; 400 mg, days 3-28) orally in combination with azacitidine 75 mg/(m2-d) subcutaneously x 7 days (D1-7), and after the target administered dose of Venegra was reached, BN104 was administered orally at the indicated dose twice daily in a continuous manner (D1-28, cycle 1 as D4-28) in 28-day treatment cycles.
- Cohort C: relapsed/refractory AML patients with specific mutations, prior treatment failure with menin inhibitors is required. The regimen is BN104 taken twice daily combined with azacitidine and venetolax.
Any patient may receive HSCT after termination of study treatment at any stage if assessed by the investigator to be amenable to hematopoietic stem cell transplantation (HSCT.) Patients whose patients are still in CR, CRh, or CRi after receiving HSCT may still continue to initiate BN104 monotherapy if they meet the appropriate criteria.
Phase II expansion part will enroll 30-45 patients and be conducted at the selected dose level to further evaluate the safety and tolerability of BN104 combined with Intensive Chemotherapy or Venetoclax/Azacitidine, as well as preliminary efficacy in Acute leukemia subjects with specific mutations (KMT2A gene rearrangement, NPM1 gene mutation and NUP98 mutation).
- Cohort D: Newly diagnosed AML patients with KMT2A rearrangements, NPM1 mutations, or NUP98 rearrangements who are fit for intensive chemotherapy.
- Cohort E: Newly diagnosed AML patients with KMT2A rearrangements, NPM1 mutations or NUP98 rearrangements who are unfit for intensive chemotherapy.
- Cohort F: relapsed/refractory AML patients with KMT2A rearrangement, NPM1 mutation or NUP98 rearrangement.
It is planned to enroll 10-15 patients in each cohort accordingly
- Conditions
- Acute Myeloid Leukemia
- Being tested
- BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine
- 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.
BN104 combined Intensive Chemotherapy or Venetoclax/AzacitidineDrug
The starting dose cohort(200mg BID N104) combined Intensive Chemotherapyor Venetoclax/Azacitidine. Each treatment cycle is anticipated to be 28 days in length, although cycle delays may be made due to delayed count recovery.
| Study group | Role | What they receive |
|---|---|---|
| BN104 Combined Intensive Chemotherapy in patients with newly diagnosed AML | Experimental | Not described Receives: Drug: BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine |
| BN104 Combined Venetoclax/Azacitidine in patients with newly diagnosed AML | Experimental | Not described Receives: Drug: BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine |
| BN104 Combined Venetoclax/Azacitidine in patients with relapsed/refractory AML | Experimental | Not described Receives: Drug: BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the safety and tolerability of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy
Incidence of DLTs (evaluated at the end of cycle 1 for each dose level);
Measured: At the end of Cycle1 (Cycle1 Day28)
Secondary outcomes (8)
Peak concentration (Cmax)
Assess the Cmax of BN104 and its metabolite BNM-1263
Measured: At the first Cycle, and Day1 of Cycle 2 (each cycle is 28days)
Auc(0-last）
Assess the area under the plasma concentration-time curve from time zero to the last quantifiable time point of BN104 and its metabolite BNM-1263
Measured: At the first Cycle, and Day1 of Cycle 2 (each cycle is 28days)
CR
To evaluate the CR rate of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy
Measured: At the screening, Cycle1Day28, Cvcle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
ORR (CR+CRh+CRi+PR+MLFS)
To evaluate the ORR rate of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy
Measured: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
DOR
To evaluate the DOR of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy
Measured: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
EFS
To evaluate the EFS of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy
Measured: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
RFS
To evaluate the RFS of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy
Measured: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
OS
To evaluate the OS of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy
Measured: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start25 Dec 2024 (estimated)
- Primary completion30 Dec 2025 (estimated)
- Study completion30 Jun 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.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chen Suning
- Sponsor type
- University, hospital or other
- Collaborators
- BioNova Pharmaceuticals (Shanghai) LTD.
- Responsible party
- Sponsor-investigator, Chen Suning, The First Affiliated Hospital of Soochow University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06746519
- Sponsor's protocol ID
- BN104-105
- Status last verified
- Dec 2024
- First submitted
- 3 Dec 2024
- Last updated
- 24 Dec 2024
- 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II , Multicenter, Open Label Clinical Study Evaluating the Safety, Pharmacokinetics, and Efficacy of the Combination of the Menin Inhibitor BN104 for the Treatment of Patients With Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06746519
- Acronym / sponsor ID
- BN104-105
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Chen SuningUniversity, hospital or other
- Collaborators
- BioNova Pharmaceuticals (Shanghai) LTD.
- Study start
- 25 Dec 2024 (estimated)
- Primary completion
- 30 Dec 2025 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 24 Dec 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.
The Phase I/II trial is to learn the safety, pharmacokinetics, and preliminary efficacy of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with acute myeloblastic leukemia.
Detailed description
The study is divided into 2 phases. Phase1 dose escalation part will enroll 90 patients to evaluate safety and tolerance of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine in patients with newly diagnosed or relapsed/refractory (R/R) acute myeloblastic leukemia with specific mutations (KMT2A gene rearrangement ,NPM1 gene mutation and NUP98 rearrangement). Patients will be allocated into 3 cohorts based on their disease status quo. Each cohort will use 3+3 dose escalation model, the starting dose level is 200mg of BN104 taken twice daily combined with Intensive Chemotherapy or Venetoclax/Azacitidine.
- Cohort A: Newly diagnosed AML patients with specific mutations who are suitable to receive BN104 combined with intensive chemotherapy(cytarabine with idarubicin or daunorubicin), which short as"7+3 induction regimen", consisting of remisson introdcution,consolidation and BN104 maintenance phase. Patients who achieve a complete remission (CR), complete remission with partial hematologic recovery (CRh), or complete remission with incomplete hematologic recovery (CRi) after 1 or 2 induction cycles may proceed on to consolidation therapy. Patients who do not achieve CR,CRh or CRi after 1 or 2 induction regimens will be considered a treatment failure and thus will be terminated from study treatment. Patients entering the consolidation phase then received an intravenous infusion of cytarabine 1-2 g/m2 every 12 hours (Q12H), using a total of 6 doses, which could be administered either consecutively at D1-3 or separately at D1, D3, and D5, depending on the study center's treatment routine. In each treatment cycle, the indicated dose of BN104 was given orally twice daily until the next cycle of consolidation treatment. Patients entering the consolidation phase receive at least 1 cycle of consolidation therapy and a maximum of 4 cycles.
After completion of consolidation therapy, patients who remain in CR, CRh, or CRi may continue to receive BN104 monotherapy maintenance therapy at the indicated dose administered twice daily for 1 cycle every 28 days until completion of 26 cycles of maintenance therapy, disease relapse/progression, receipt of hematopoietic stem cell transplantation, intolerable toxicity, loss to visit, withdrawal of informed consent, death, or other circumstances that, in the judgment of the investigator, require the termination of study drug, whichever occurs first.
- Cohort B: Newly diagnosed AML patients with specific mutations who are ≥75 years of age or <75 years of age but are not suitable for intensive chemotherapy due to co-morbidities. The regimen is BN104 taken twice daily combined with azacitidine and venetolax. Venetolax (100 mg, day 1; 200 mg, day 2; 400 mg, days 3-28) orally in combination with azacitidine 75 mg/(m2-d) subcutaneously x 7 days (D1-7), and after the target administered dose of Venegra was reached, BN104 was administered orally at the indicated dose twice daily in a continuous manner (D1-28, cycle 1 as D4-28) in 28-day treatment cycles.
- Cohort C: relapsed/refractory AML patients with specific mutations, prior treatment failure with menin inhibitors is required. The regimen is BN104 taken twice daily combined with azacitidine and venetolax.
Any patient may receive HSCT after termination of study treatment at any stage if assessed by the investigator to be amenable to hematopoietic stem cell transplantation (HSCT.) Patients whose patients are still in CR, CRh, or CRi after receiving HSCT may still continue to initiate BN104 monotherapy if they meet the appropriate criteria.
Phase II expansion part will enroll 30-45 patients and be conducted at the selected dose level to further evaluate the safety and tolerability of BN104 combined with Intensive Chemotherapy or Venetoclax/Azacitidine, as well as preliminary efficacy in Acute leukemia subjects with specific mutations (KMT2A gene rearrangement, NPM1 gene mutation and NUP98 mutation).
- Cohort D: Newly diagnosed AML patients with KMT2A rearrangements, NPM1 mutations, or NUP98 rearrangements who are fit for intensive chemotherapy.
- Cohort E: Newly diagnosed AML patients with KMT2A rearrangements, NPM1 mutations or NUP98 rearrangements who are unfit for intensive chemotherapy.
- Cohort F: relapsed/refractory AML patients with KMT2A rearrangement, NPM1 mutation or NUP98 rearrangement.
It is planned to enroll 10-15 patients in each cohort accordingly
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BN104 Combined Intensive Chemotherapy in patients with newly diagnosed AML | Experimental | Drug: BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine |
| BN104 Combined Venetoclax/Azacitidine in patients with newly diagnosed AML | Experimental | Drug: BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine |
| BN104 Combined Venetoclax/Azacitidine in patients with relapsed/refractory AML | Experimental | Drug: BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Have been fully informed about the study and have voluntarily signed the ICF;
- Patients with newly diagnosed primary AML according to the 2022 World Health Organization (WHO) criteria (Groups A and B) or patients with relapsed/refractory AML who have been previously treated with menin inhibitor monotherapy (Group C) and have an intermediate or poor prognosis according to the 2022 ELN Risk Stratification, as well as a defined combination of NPM1 mutation or NUP98 rearrangement or KMT2A rearrangement
- Peripheral blood leukocyte count ≤ 25 x 109/L (limited to patients enrolled in groups B and C, where hydroxyurea is allowed to control peripheral blood leukocyte count)
- Aged 18 years or older;
- ECOG (GroupA and B:0,1,2; GroupC:0,1,2,3)
Key exclusion criteria (16 listed)
- have active central nervous system (CNS) leukemia;
- a known history of clinically significant liver disease, including viral or other hepatitis or cirrhosis:Positive hepatitis B surface antigen (HBsAg) serology requires a negative hepatitis B virus (HBV) DNA test for enrollment; For patients with hepatitis C virus (HCV) antibody serology positive, a negative HCV RNA test result is required for enrollment.
- known human immunodeficiency virus (HIV) infection;
- pregnant (positive screening pregnancy test) or lactating females;
- meet any of the following cardiac-related criteria:Hereditary long QT interval syndrome or QTcF > 450 msec;Various clinically significant cardiovascular diseases, including acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting within 6 months prior to enrollment, congestive heart failure graded by the New York Heart Association (NYHA) as grade 2 or higher (inclusive);
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 |
|---|---|---|
| BN104 combined Intensive Chemotherapy or Venetoclax/AzacitidineThe starting dose cohort(200mg BID N104) combined Intensive Chemotherapyor Venetoclax/Azacitidine. Each treatment cycle is anticipated to be 28 days in length, although cycle delays may be made due to delayed count recovery. | Drug | BN104 Combined Intensive Chemotherapy in patients with newly diagnosed AML, BN104 Combined Venetoclax/Azacitidine in patients with newly diagnosed AML, BN104 Combined Venetoclax/Azacitidine in patients with relapsed/refractory AML |
Primary outcome
Evaluate the safety and tolerability of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy
Time frame: At the end of Cycle1 (Cycle1 Day28)
Incidence of DLTs (evaluated at the end of cycle 1 for each dose level);
8 secondary outcomes
Peak concentration (Cmax)
Time frame: At the first Cycle, and Day1 of Cycle 2 (each cycle is 28days)
Auc(0-last）
Time frame: At the first Cycle, and Day1 of Cycle 2 (each cycle is 28days)
CR
Time frame: At the screening, Cycle1Day28, Cvcle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
ORR (CR+CRh+CRi+PR+MLFS)
Time frame: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
DOR
Time frame: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
EFS
Time frame: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
RFS
Time frame: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
OS
Time frame: At the screening, Cycle1Day28, Cycle4Day1, Cycle7Day1, Cycle10Day1 (do the efficacy assessment each 3 cycles, each cycle is 28 days)
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 Dec 2024.
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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 Phase 1/2 study testing BN104 combined Intensive Chemotherapy or Venetoclax/Azacitidine in people with Acute Myeloid Leukemia, run by Chen Suning 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 12 inclusion and 16 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 24 Dec 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Suning Chen, Doctor (051265223637, chensuning@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the safety and tolerability of BN104 in combination with Venetoclax/Azacitidine or intensive chemotherapy (time frame: At the end of Cycle1 (Cycle1 Day28)). 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 Dec 2024.