Health TrialsbyHealthPanel

UCMSC-Exo for Chemotherapy-induced Myelosuppression in Acute Myeloid Leukemia

ConditionsAcute Myeloid LeukemiaNeutropeniaAnemiaThrombocytopeniaInfectionsBleeding
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • umbilical cord derived mesenchymal stem cells exosomes (UCMSC-Exo)

    Biological/Vaccine

    UCMSC-Exo will be infused intravenously.

Treatment groups

9 Participants
are divided into 1 treatment group
Group A: UCMSC-Exo interventionExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)

To investigate the safety characteristics, percentages will be calculated and grade will be evaluated.

Time frame
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)

During the DLT observation period, the subject has an adverse event that is reasonably related to UCMSC-Exo infusion (possibly, likely or definitely related).

Time frame
From the day that UCMSC-Exo is infused to up to 14 days
3

Maximum tolerated dose (MTD)

During the dose-escalation, the highest dose of dose-limiting toxicity for subjects no more than 1/6 in the dose group of at least 6 evaluable subjects of the study drug.

Time frame
From the day that UCMSC-Exo is infused to up to 14 days

Secondary outcomes

1

Time to absolute neutrophil count recovery

To investigate the efficacy characteristics, time will be measured in days.

Time frame
From the start of chemotherapy to up to 42 days
2

Incidence of febrile neutropenia

To investigate the efficacy characteristics, percentages will be calculated.

Time frame
From the start of chemotherapy to up to 42 days
3

Duration of febrile neutropenia

To investigate the efficacy characteristics, the duration will be measured in days.

Time frame
From the start of chemotherapy to up to 42 days
4

Incidence of severe thrombocytopenia

To investigate the efficacy characteristics, percentages will be calculated.

Time frame
From the start of chemotherapy to up to 42 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Lead sponsor

Source ClinicalTrials.gov
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