Acute Myeloid LeukemiaPhase 1NCT04471064
A Study of XY0206 Tablets in Patients With Relapsed / Refractory Acute Myeloid Leukemia
A Phase 1 study testing XY0206 in people with Acute Myeloid Leukemia, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd at 1 site in China.
Trial summary
1. To evaluate the safety and tolerability of xy0206 as single drug in the treatment of relapsed / refractory AML; 2. Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as single drug in the treatment of relapsed / refractory AML subjects. 3. 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?
- XY0206
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2020to Feb 2024
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria before entering the group:
- 1. At least 18 years old; 2. Based on the World Health Organization (WHO) 2016 classification, the patients who were confirmed by the morphology of bone marrow cells and met the diagnosis criteria of relapsed / refractory AML (refer to the Chinese diagnosis and treatment guidelines for relapsed and refractory acute myeloid leukemia (2017 version)), the diagnosis criteria of relapsed AML: after CR, the peripheral blood once again showed leukemia cells or the original / immature cells in bone marrow were more than 5% (except the bone marrow after consolidated chemotherapy) The diagnosis standard of refractory AML: the primary refractory disease that has not been completely relieved after two courses of chemotherapy induced by standard regimen (including cytarabine and an anthracycline or anthraquinone drug); 3. ECOG physical fitness score is ≤ 2 points ; 4 Estimated survival time ≥ 12 weeks; 5 The organ function level of subjects must meet the following requirements:
- Blood routine test: WBC ≤ 30 × 109 / L (it is allowed to take hydroxyurea until 3 days before administration of test drug to stabilize WBC);
- Blood biochemistry: serum creatinine (Scr) ≤ 1.5 × ULN or creatinine clearance rate (Ccr) ≥ 60 ml / min (using Cockcroft -Gault formula); alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN (liver with leukemia cell infiltration ≤ 5 × ULN), total bilirubin (TBIL) ≤ 1.5 × ULN;
- Electrolyte: the content of potassium, sodium, calcium and magnesium in the blood is within the normal value range of the laboratory (if the abnormal laboratory result judged by the researcher is of no clinical significance or can be controlled within the normal value range by drugs in the screening period, the subject can be included in the group);
- Coagulation function: INR ≤ 1.5 × ULN, APTT < 10 seconds, PT < 3 seconds, FIB ≥ 1.5g/l (blood products or drugs are allowed to be corrected 3 days before administration of test drugs);
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- Friderica corrected QT value (QTC) for male ≤ 450 ms or female ≤ 470 MS;
- LVEF≥ 50%；
- Urinary protein < 2 + was detected in urine routine. If urinary protein ≥ 2 +, 24-hour urinary protein quantification is needed, and only when 24-hour urinary protein < 2g can be enrolled in the group; 6. The serum pregnancy test must be carried out within 28 days before receiving the first dose of study drug and the result must be negative. The women of childbearing age and the male subjects agree to adopt the routine and effective contraceptive measures during the whole study period and within 6 months after the treatment; 7. The subjects should be willing to provide effective diagnosis evidence before treatment or accept bone marrow puncture or biopsy for diagnosis, and accept bone marrow puncture or biopsy for efficacy evaluation after treatment; 8. Volunteer to participate in clinical research and sign informed consent in writing.
Who cannot join
- Patients cannot participate in this clinical study if they meet any of the following conditions:
- Known allergy to the study drug or any of its ingredients; has been treated with sunitinib malate, or allergy to sunitinib malate;
- BCR / ABL positive leukemia (chronic myeloid leukemia);
- The subjects had central nervous system leukemia;
- The subjects had secondary AML after chemotherapy for other tumors (except MDS);
- At the same time, patients with other malignant tumors (except for those with cured stage IB or lower grade cervical cancer, non-invasive basal cell or squamous cell skin cancer, malignant melanoma with complete remission (CR) > 10 years, and other malignant tumors with complete remission (CR) > 5 years);
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- Treatment before the trial:
- Previous treatment with FLT3 inhibitor;
- Patients who have received allogeneic hematopoietic stem cell transplantation before;
- Received chemotherapy, biotherapy, targeted antitumor therapy within 28 days before starting to use the study drug, and radiotherapy within 14 days;
- Drugs with significant effect on P450 metabolic enzyme pathway taken within 2 weeks before the screening period;
- Have participated in other clinical studies and applied research drugs within 28 days before starting to use research drugs;
- Major surgery or significant traumatic injury within 28 days prior to the first administration of the study treatment or maybe major surgery is needed during the study treatment period;
- Concomitant drugs that may cause QTc prolongation or induce torsade de pointes (TdP) are required, in addition to antimicrobials used as standard therapy for the prevention or treatment of infection and other such drugs considered essential by the researchers;
- The toxic and side effects caused by previous treatment did not recover to CTCAE ≤ 1, except for hair loss and other tolerable events judged by the researchers;
- Combined diseases:
- One or more HBsAg, HCV, anti HIV or anti Treponema pallidum specific antibodies are positive;
- Clinically significant gastrointestinal abnormalities that may affect drug intake, transport or absorption (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, peptic ulcer, etc.), subjects with total gastrectomy, or patients with malabsorption syndrome;
- Have a history of uncontrolled epilepsy, central nervous system disease or mental illness;
- Hypertension with poor drug control (persistent systolic blood pressure ≥ 150 mmHg and / or diastolic blood pressure ≥ 100 mmHg despite antihypertensive treatment);
- Poorly controlled diabetes mellitus (fasting blood glucose continues to be > 7.1mmol/L despite hypoglycemic treatment), or insulin-dependent diabetes mellitus (type I diabetes), or non insulin-dependent diabetes mellitus with small vessel disease, or pancreatic dysfunction;
- In the 12 months before the first application, there were any of the following conditions: symptomatic congestive heart failure (New York Heart Association class II-IV), uncontrolled arrhythmia, angina pectoris, myocardial infarction, stroke (except lacunar infarction), coronary / peripheral artery bypass surgery, pulmonary embolism;
- Long QT syndrome with congenital long QT interval syndrome or known family history;
- There is a history of LVEF falling below 40%;
- Uncontrolled active infections (bacteria, viruses, fungi, etc.);
- Bleeding grade ≥ grade 3 ;
- Have adrenal insufficiency;
- The thyroid function was abnormal in the past, or could not be maintained in the normal range even under the condition of drug treatment;
- Currently, there are serious unhealed wounds, ulcers or fractures;
- Stevens Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN);
- For female subjects: currently in pregnancy or lactation;
- Any previous or current disease, treatment, or laboratory abnormality that may interfere with the results of the study, affect the subject's participation in the whole process of the study, or the subject is not suitable for the study in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300052
Junyuan Qi, MD, 18622662361, qi_jy@yahoo.com
About this study
Official title: A Multicenter, Open, Dose Increasing Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Primary Efficacy of xy0206 Tablets in Relapsed / Refractory Acute Myeloid Leukemia Subjects
- To evaluate the safety and tolerability of xy0206 as single drug in the treatment of relapsed / refractory AML;
- Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as single drug in the treatment of relapsed / refractory AML subjects.
- To evaluate the pharmacokinetic (PK), pharmacokinetic (PD) characteristics and PK / PD correlation of xy0206 as single drug treatment in relapsed / refractory AML subjects;
- To evaluate the primary efficacy of xy0206 as single drug in the treatment of relapsed / refractory AML patients;
- To evaluate biomarkers of xy0206 as single drug treatment for relapsed / refractory AML subjects.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- XY0206
- 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.
XY0206Drug
Dosage form:Tablet;Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the withdrawal criteria. The duration and interval of treatment were determined according to the accumulated condition after multiple dose.
| Study group | Role | What they receive |
|---|---|---|
| XY0206-12.5mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg; multiple dose phase Receives: Drug: XY0206 |
| XY0206-25mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：25mg; multiple dose phase Receives: Drug: XY0206 |
| XY0206-50mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：50mg; multiple dose phase Receives: Drug: XY0206 |
| XY0206-100mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：100mg; multiple dose phase Receives: Drug: XY0206 |
| XY0206-150mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：150mg; multiple dose phase Receives: Drug: XY0206 |
| XY0206-200mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：200mg; multiple dose phase Receives: Drug: XY0206 |
| XY0206-250mg | Experimental | Drug:XY0206;Dosage form:Tablet;Dosage：250mg; multiple dose phase Receives: Drug: XY0206 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerable dose
The occurrence of Maximum tolerable dose.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Dose limiting toxicity
The occurrence of Dose limiting toxicity.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Adverse event
The occurrence rate of Adverse event.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Adverse drug reactions
The occurrence rate of adverse drug reactions.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Serious adverse events
The occurrence rate of Serious adverse events.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood routine
Check whether the red blood cell system, white blood cell system and platelet system are normal
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Urine routine
Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Stool routine
Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood biochemistry
The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Serum amylase / lipase
Evaluation of pancreatic function
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Coagulation function
Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
ECG
Evaluation of QT interval
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Echocardiography
To evaluate the electrophysiological condition of the heart
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Imaging examination
Chest X-ray/CT
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Body temperature
One of the vital signs.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Blood pressure
Assess whether systolic blood pressure and diastolic blood pressure are normal
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Heart rate
One of the vital signs.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Breathing
Assess if breathing is normal
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Skin
Assess if the skin is normal.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Head
Head examination includes head, eyes, ears, nose, lips, etc.Assess if head is normal
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Neck
Neck examination includes thyroid gland, lymph node, etc.Assess if neck is normal.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Chest
Chest examination includes lung, cardiovascular, etc.Assess if chest is normal.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Abdomen
Abdominal examination includes liver and spleen.Assess if abdomen is normal.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Limbs
Assess if limbs is normal.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Nerves
Assess nerve function by communication
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Back/spine
Assess if back/spine is normal.
Measured: from the start of the medication to the end of the study or 28 days after cessation of medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start15 Sep 2020
- Primary completionFeb 2024 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Proswell Medical Corporation
- Responsible party
- Sponsor
- Investigators
- Junyuan Qi, MD, Principal investigator, Institute of Hematology, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04471064
- Sponsor's protocol ID
- HY-XY0206-Ⅰ-02
- Status last verified
- May 2023
- First submitted
- 1 Jul 2020
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shen L, Yang Y, Xu C, Jiang B, Duan X, Shao X, Li S, Liu S, Huang C, Song L, Sun M, Fan J, Wang N, Zhang D, Fang Y, Kang L, Jiang Y, Niu M, Qi J, Cheng T, Wang H. XY0206 targets FLT3-dependent resistance states in acute myeloid leukemia. J Clin Invest. 2026 Sep 1;136(20):e204701. doi: 10.1172/JCI204701. eCollection 2026 Oct 15.
PubMed 42678731Song L, Wei X, Zhai Z, Wang A, Jiang D, Liang Y, Li F, Jiang Z, Zhang X, Guo Q, Jing H, Xu Y, Tong X, Wang J, Wang J, Qi J. Phase I/II Trial of the FLT3 Kinase Inhibitor XY0206 in Patients With Relapsed/Refractory Acute Myeloid Leukemia. Eur J Haematol. 2026 Aug;117(2):422-431. doi: 10.1111/ejh.70164. Epub 2026 Apr 21.
PubMed 42015516
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open, Dose Increasing Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Primary Efficacy of xy0206 Tablets in Relapsed / Refractory Acute Myeloid Leukemia Subjects
- ClinicalTrials.gov ID
- NCT04471064
- Acronym / sponsor ID
- HY-XY0206-Ⅰ-02
- Conditions
- Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Shijiazhuang Yiling Pharmaceutical Co. LtdIndustry (pharma, biotech, devices)
- Collaborators
- Proswell Medical Corporation
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- Feb 2024 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 14 Jul 2020 (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.
- To evaluate the safety and tolerability of xy0206 as single drug in the treatment of relapsed / refractory AML;
- Evaluate the dose limited toxicity (DLT) and maximum tolerable dose (MTD) of xy0206 as single drug in the treatment of relapsed / refractory AML subjects.
- To evaluate the pharmacokinetic (PK), pharmacokinetic (PD) characteristics and PK / PD correlation of xy0206 as single drug treatment in relapsed / refractory AML subjects;
- To evaluate the primary efficacy of xy0206 as single drug in the treatment of relapsed / refractory AML patients;
- To evaluate biomarkers of xy0206 as single drug treatment for relapsed / refractory AML subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| XY0206-12.5mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：12.5mg; multiple dose phase |
| XY0206-25mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：25mg; multiple dose phase |
| XY0206-50mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：50mg; multiple dose phase |
| XY0206-100mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：100mg; multiple dose phase |
| XY0206-150mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：150mg; multiple dose phase |
| XY0206-200mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：200mg; multiple dose phase |
| XY0206-250mg | Experimental | Drug: XY0206Drug:XY0206;Dosage form:Tablet;Dosage：250mg; multiple dose phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must meet all of the following criteria before entering the group:
- 1. At least 18 years old; 2. Based on the World Health Organization (WHO) 2016 classification, the patients who were confirmed by the morphology of bone marrow cells and met the diagnosis criteria of relapsed / refractory AML (refer to the Chinese diagnosis and treatment guidelines for relapsed and refractory acute myeloid leukemia (2017 version)), the diagnosis criteria of relapsed AML: after CR, the peripheral blood once again showed leukemia cells or the original / immature cells in bone marrow were more than 5% (except the bone marrow after consolidated chemotherapy) The diagnosis standard of refractory AML: the primary refractory disease that has not been completely relieved after two courses of chemotherapy induced by standard regimen (including cytarabine and an anthracycline or anthraquinone drug); 3. ECOG physical fitness score is ≤ 2 points ; 4 Estimated survival time ≥ 12 weeks; 5 The organ function level of subjects must meet the following requirements:
Key exclusion criteria (32 listed)
- Patients cannot participate in this clinical study if they meet any of the following conditions:
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 |
|---|---|---|
| XY0206Dosage form:Tablet;Multiple dose phase:Take the medicine once a day,1 tablet at a time.4 weeks of continuous medication is one course of treatment. After the first course of treatment, the subjects can continue to receive the experimental drug treatment until they meet the withdrawal criteria. The duration and interval of treatment were determined according to the accumulated condition after multiple dose. | Drug | XY0206-100mg, XY0206-12.5mg, XY0206-150mg, XY0206-200mg, XY0206-250mg, XY0206-25mg, XY0206-50mg |
Primary outcome
Maximum tolerable dose
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence of Maximum tolerable dose.
Dose limiting toxicity
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence of Dose limiting toxicity.
Adverse event
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence rate of Adverse event.
Adverse drug reactions
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence rate of adverse drug reactions.
Serious adverse events
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The occurrence rate of Serious adverse events.
Blood routine
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Check whether the red blood cell system, white blood cell system and platelet system are normal
Urine routine
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Urine routine examination includes urine color, transparency, pH, red blood cells, white blood cells, epithelial cells, tube type, protein, specific gravity and urine sugar.
Stool routine
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Routine stool tests include the detection of red and white blood cells in feces, bacterial sensitivity test, occult blood test (OB) and inspection of eggs.
Blood biochemistry
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
The contents of various ions, sugars, lipids, proteins, enzymes, hormones and metabolites in blood were detected
Serum amylase / lipase
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Evaluation of pancreatic function
Coagulation function
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Four coagulation parameters including prothrombin time (PT), activated partial thromboplastin time (APTT), thrombin time (TT) and fibrinogen (FIB) were evaluated.
ECG
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Evaluation of QT interval
Echocardiography
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
To evaluate the electrophysiological condition of the heart
Imaging examination
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Chest X-ray/CT
Body temperature
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the vital signs.
Blood pressure
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Assess whether systolic blood pressure and diastolic blood pressure are normal
Heart rate
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
One of the vital signs.
Breathing
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Assess if breathing is normal
Skin
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Assess if the skin is normal.
Head
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Head examination includes head, eyes, ears, nose, lips, etc.Assess if head is normal
Neck
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Neck examination includes thyroid gland, lymph node, etc.Assess if neck is normal.
Chest
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Chest examination includes lung, cardiovascular, etc.Assess if chest is normal.
Abdomen
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Abdominal examination includes liver and spleen.Assess if abdomen is normal.
Limbs
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Assess if limbs is normal.
Nerves
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Assess nerve function by communication
Back/spine
Time frame: from the start of the medication to the end of the study or 28 days after cessation of medication
Assess if back/spine is normal.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Derived from this study: PubMed 42678731Shen L, Yang Y, Xu C, Jiang B, Duan X, Shao X, Li S, Liu S, Huang C, Song L, Sun M, Fan J, Wang N, Zhang D, Fang Y, Kang L, Jiang Y, Niu M, Qi J, Cheng T, Wang H. XY0206 targets FLT3-dependent resistance states in acute myeloid leukemia. J Clin Invest. 2026 Sep 1;136(20):e204701. doi: 10.1172/JCI204701. eCollection 2026 Oct 15.
- Derived from this study: PubMed 42015516Song L, Wei X, Zhai Z, Wang A, Jiang D, Liang Y, Li F, Jiang Z, Zhang X, Guo Q, Jing H, Xu Y, Tong X, Wang J, Wang J, Qi J. Phase I/II Trial of the FLT3 Kinase Inhibitor XY0206 in Patients With Relapsed/Refractory Acute Myeloid Leukemia. Eur J Haematol. 2026 Aug;117(2):422-431. doi: 10.1111/ejh.70164. Epub 2026 Apr 21.
- 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.
Junyuan Qi, MD principal investigator
Institute of Hematology, Chinese Academy of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing XY0206 in people with Acute Myeloid Leukemia, run by Shijiazhuang Yiling Pharmaceutical Co. Ltd 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 9 inclusion and 32 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 18 May 2023. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 wei Wang, master (086-0311-66703017, wangwei001@yiling.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum tolerable dose (time frame: from the start of the medication to the end of the study or 28 days after cessation of medication). The study lists 26 primary outcomes in all. 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 NCT04471064, which also lists 2 linked publications.
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 18 May 2023.