Umbilical Cord Derived Mesenchymal Stem Cells for Treatment-induced Myelosuppression in Hematolog… (NCT05672420) | Clinical Trial Compass
UnknownPhase 1/2
Umbilical Cord Derived Mesenchymal Stem Cells for Treatment-induced Myelosuppression in Hematologic Malignancies
China181 participantsStarted 2023-01-01
Plain-language summary
The purpose of the study is to explore the safety and efficacy of umbilical cord derived mesenchymal stem cells in treatment-induced myelosuppression in patients with hematologic malignancies.
Who can participate
Age range18 Years – 75 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Aged between 18 and 75 years old;
✓. Either type of primary hematologic malignancies listed below:
✓. Acute myeloid leukemia (AML, AML subtype M3 excluded) or acute lymphoblastic leukemia (ALL) diagosed according to the 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia, either treatment naive participants who are going to receive first induction therapy, or participants who failed first induction therapy and are going to receive re-inducton therapy;
✓. AML or ALL participants who achieved remission and are going to receive consolidation therapy;
✓. Relapsed/refractory AML or ALL participants who are going to receive first re-induction therapy;
✓. Phase II trial will also include: participants with primary hematological maligancies who are going to receive autologous hematopoietic stem cell transplantation (allo-HSCT) whereas are poor mobilizers (CD34+cell count in peripheral blood was below 11-19/μL before collection, or the amount of CD34+ cells transfused was below 2×10\^6/kg in allo-HSCT), and the participants' peripheral superficial veins have smooth blood flow which can meet the demand for intravenous drip;
✓. 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;
Exclusion criteria
✕. Overt central nervous system manifestations of hematologic malignancies at diagnosis;
What they're measuring
1
Dose-limiting toxicities（DLT)
Timeframe: 4 days after the last UC-MSCs dose, up to 12 days
2
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: From the day that the last UC-MSCs dose is used to up to 21 days
3
Maximum tolerated dose (MTD)
Timeframe: From the day that the last UC-MSCs dose is used to up to 4 days
Trial details
NCT IDNCT05672420
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
✕. Body mass index (BMI) of more than 30 kg/m\^2;
✕. 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;