Actively Recruiting

Phase 1
Age: 18Years - 60Years
All Genders
NCT06245746

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

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-03-21

9

Participants Needed

1

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged between 18 and 60 years old
  • Diagnosed with acute myeloid leukemia (AML, excluding subtype M3) with complete remission
  • Planning to receive consolidation chemotherapy (cytarabine or cytarabine-based regimen)
  • Male or female
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  • Estimated survival of at least 3 months
  • Adequate respiratory, cardiac, hepatic, and renal function
  • No anti-cancer therapy within 2 weeks before enrollment and recovered from previous treatment toxicities to Grade 1 or below
  • Agree to use medically recognized contraception during and for 6 months after treatment if of childbearing potential
Not Eligible

You will not qualify if you...

  • Central nervous system manifestations of acute myeloid leukemia at diagnosis
  • Secondary acute myeloid leukemia
  • Myelosuppression caused by conditions other than anti-cancer therapy
  • Prior radiation therapy to sternum or pelvis
  • Uncontrolled infection or active bleeding at enrollment
  • Severe comorbidities affecting survival, such as cachexia or severe malnutrition
  • Estimated survival of 48 hours or less
  • Active hepatitis B or C infection
  • History or current HIV infection
  • Syphilis infection
  • Use of immunosuppressants or organ transplant within last 6 months
  • Participation in other clinical drug trials within 6 weeks before enrollment
  • Previous participation in stem cell or exosome clinical research
  • Concurrent use of agents inhibiting cell division with UCMSC-Exo infusion
  • Severe allergies or known allergy to study drug components
  • Contraindications to hematopoietic growth factors, blood transfusions, or anti-infective agents
  • Pregnant or breastfeeding females
  • Mental illness or drug abuse
  • History of other malignancies within 3 years except hematological malignancies
  • Poor compliance or inability to complete the study
  • Other conditions judged by investigator to increase risk or interfere with the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Wuhan Union Hospital

Wuhan, Hubei, China, 430000

Actively Recruiting

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Research Team

Q

Qiubai Li, Professor

CONTACT

D

Di Wu

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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