UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia (NCT06245746) | Clinical Trial Compass
RecruitingPhase 1
UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia
China9 participantsStarted 2025-02-26
Plain-language 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.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Aged between 18 and 60 years old;
✓. 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);
✓. 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;
✓. Male or female;
✓. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day chemotherapy is initiated)
✓. Estimated survival of at least 3 months;
✓. Adequate major organ function:
✓. Respiratory function: indoor oxygen saturation of at least 95%;
Exclusion criteria
✕. Central nervous system manifestations of acute myeloid leukemia at diagnosis;
✕. Secondary acute myeloid leukemia;
✕. Myelosuppression induced by conditions other than anti-cancer therapy;
✕. Previous radiation therapy performed on sternum or pelvis;
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From the day that UCMSC-Exo is infused to up to 28 days (short-term safety follow-up) and 1 year (long-term safety follow-up)
2
Dose-limiting toxicities（DLT)
Timeframe: From the day that UCMSC-Exo is infused to up to 14 days
3
Maximum tolerated dose (MTD)
Timeframe: From the day that UCMSC-Exo is infused to up to 14 days
Trial details
NCT IDNCT06245746
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
✕. Specifically diagnosed and uncontrolled infection at enrollment (Uncontrolled is defined as exhibiting ongoing signs and symptoms of infection without improvement despite anti-infective agents) ;
✕. Uncontrolled active bleeding at enrollment;
✕. Severe underlying comorbidities affecting survival, including cachexia, severe malnutrition, etc;