NCT06245746 UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia
| NCT ID | NCT06245746 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Union Hospital, Tongji Medical College, Huazhong University of Science and Technology |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 9 participants |
| Start Date | 2025-02-26 |
| Primary Completion | 2026-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 9 participants in total. It began in 2025-02-26 with a primary completion date of 2026-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of the study is to explore the safety and efficacy of UCMSC-Exo in consolidation chemotherapy-induced myelosuppression in patients with acute myeloid leukemia after achieving complete remission.
Eligibility Criteria
Inclusion Criteria: 1. Aged between 18 and 60 years old; 2. Acute myeloid leukemia (AML, AML subtype M3 excluded) diagnosed according to the 2022 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia, who have achieved complete remission (CR1) and are going to receive consolidation therapy (cytarabine or cytarabine-based combined regimen, the cycle of consolidation therapy is not limited); 3. The participant or his/her legal guardian is adequately informed of the nature and risks of the study, voluntarily participates in the study with signed informed consent; 4. Male or female; 5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day chemotherapy is initiated) 6. Estimated survival of at least 3 months; 7. Adequate major organ function: 1. Respiratory function: indoor oxygen saturation of at least 95%; 2. Cardiac function: ejection fraction of left ventricular of at least 45%; 3. Hepatic function: alanine aminotransferase/aspartate aminotransferase of at most 2.5 times/upper limit of normal value and serum total bilirubin of at most 1.5 times/upper limit of normal value; 4. Renal function: Serum creatinine of at most 1.5 times/upper limit of normal value; 8. Participants who do not receive any type of anti-cancer therapy within 2 weeks before enrollment (radiation therapy, chemotherapy and/or immune therapy, et al.), and treatment-associated toxicities induced by previous therapy has recovered to Grade 1 or below (except for low grade toxicities such as alopecia). 9. For female participants, they should be surgical sterilized or post-menopausal, or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study; For male participants, they should be surgical sterilized or agree to utilize a medically recognised method of contraception (such as intrauterine device, condom) during treatment period of the study and within 6 months after the end of treatment period of the study; Exclusion Criteria: 1. Central nervous system manifestations of acute myeloid leukemia at diagnosis; 2. Secondary acute myeloid leukemia; 3. Myelosuppression induced by conditions other than anti-cancer therapy; 4. Previous radiation therapy performed on sternum or pelvis; 5. Specifically diagnosed and uncontrolled infection at enrollment (Uncontrolled is defined as exhibiting ongoing signs and symptoms of infection without improvement despite anti-infective agents) ; 6. Uncontrolled active bleeding at enrollment; 7. Severe underlying comorbidities affecting survival, including cachexia, severe malnutrition, etc; 8. Estimated survival of at most 48 hours; 9. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; 10. History of or current human immunodeficiency virus (HIV) infection; 11. Syphilis infection; 12. Continuous usage of immunosuppressants or received organ transplantation in the last 6 months; 13. Participation in clinical trials of other drugs within 6 weeks before enrollment; 14. Previous participation in clinical stem cell or exosome research; 15. Receive any agent concurrently with UCMSC-Exo infusion which inhibits cell division (hydroxyurea, low-dose cytarabine or methotrexate, etc) ; 16. Severe allergic constitution, or known or suspected allergy to the study drug and its components; 17. Known contraindication to receiving hematopoietic growth factors, transfusion of blood components, anti-infective agents; 18. Female participants who are pregnant or breast feeding; 19. Participants suffering from mental illness; 20. Presence of drug abuse/addiction; 21. History of other malignancies other than hematological malignancies within 3 years; 22. Participants without signed informed consent; 23. Participants with poor compliance and are unable to complete the whole course of the study; 24. Participants with circumstances that, in the opinion of the investigator, may increase the risk of the participants or interfere with conduct of the clinical trial and the judgment of results (excessive tension, sensitivity or cognitive impairment, etc) ; 25. Participants with other circumstances that are ineligible for enrollment in this study, in the opinion of the investigator.
Contact & Investigator
Qiubai Li, Professor
PRINCIPAL INVESTIGATOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Frequently Asked Questions
Who can join the NCT06245746 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06245746 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06245746 currently recruiting?
Yes, NCT06245746 is actively recruiting participants. Contact the research team at qiubaili@hust.edu.cn for enrollment information.
Where is the NCT06245746 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT06245746 clinical trial?
NCT06245746 is sponsored by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The principal investigator is Qiubai Li, Professor at Union Hospital, Tongji Medical College, Huazhong University of Science and Technology. The trial plans to enroll 9 participants.
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