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New treatment option for Acute Myeloid Leukemia
Official title UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia
ClinicalTrials.gov ID: NCT06245746
What this study is testing
What is umbilical cord derived mesenchymal stem cells exosomes (UCMSC-Exo)?
umbilical cord derived mesenchymal stem cells exosomes (UCMSC-Exo) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute myeloid leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 60
You may be able to join if
- 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...
- The participant or his/her legal guardian is adequately informed of the nature and risks of the study, voluntarily participates in the study with...
- Male or female;
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day chemotherapy is initiated)
You likely can't join if
- 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;
- Specifically diagnosed and uncontrolled infection at enrollment (Uncontrolled is defined as exhibiting ongoing signs and symptoms of infection...
- Uncontrolled active bleeding at enrollment;
See the full eligibility 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...
- 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%;
- Cardiac function: ejection fraction of left ventricular of at least 45%;
- 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;
- Renal function: Serum creatinine of at most 1.5 times/upper limit of normal value;
- 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...
- 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...
- 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;
- 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;
- Estimated survival of at most 48 hours;
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
- History of or current human immunodeficiency virus (HIV) infection;
- Syphilis infection;
- Continuous usage of immunosuppressants or received organ transplantation in the last 6 months;
- Participation in clinical trials of other drugs within 6 weeks before enrollment;
- Previous participation in clinical stem cell or exosome research;
- Receive any agent concurrently with UCMSC-Exo infusion which inhibits cell division (hydroxyurea, low-dose cytarabine or methotrexate, etc) ;
- Severe allergic constitution, or known or suspected allergy to the study drug and its components;
- Known contraindication to receiving hematopoietic growth factors, transfusion of blood components, anti-infective agents;
- Female participants who are pregnant or breast feeding;
- Participants suffering from mental illness;
- Presence of drug abuse/addiction;
- History of other malignancies other than hematological malignancies within 3 years;
- Participants without signed informed consent;
- Participants with poor compliance and are unable to complete the whole course of the study;
- 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...
- Participants with other circumstances that are ineligible for enrollment in this study, in the opinion of the investigator.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 60 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.