Trial Title:
Umbilical Cord Derived Mesenchymal Stem Cells for Treatment-induced Myelosuppression in Hematologic Malignancies
NCT ID:
NCT05672420
Condition:
Hematologic Neoplasms
Neutropenia
Anemia
Thrombocytopenia
Infections
Bleeding
Conditions: Official terms:
Neoplasms
Hematologic Neoplasms
Thrombocytopenia
Neutropenia
Conditions: Keywords:
umbilical cord derived mesenchymal stem cells
treatment-induced myelosuppression
neutropenia
anemia
thrombocytopenia
infections
bleeding
hematologic malignancies
leukemia
lymphoma
multiple myeloma
chemotherapy
targeted therapy
hematopoietic stem cell transplantation
Study type:
Interventional
Study phase:
Phase 1/Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
umbilical cord derived mesenchymal stem cells
Description:
umbilical cord derived mesenchymal stem cells, intravenous infusion
Arm group label:
umbilical cord derived mesenchymal stem cells (UC-MSCs)
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.
Detailed description:
Despite the improved prognosis of patients with hematologic malignancies, almost all
patients will experience severe myelosuppression induced by anti-cancer treatment,
leading to a series of complications such as infection due to neutropenia, bleeding due
to thrombocytopenia and/or impaired major organ function such as cardiac function due to
anemia, which are the main reasons for dose reduction, dose interrruptions of anti-cancer
treatment, failure of hematopoietic stem cell transplantation, and also patients'
treatment-related death. It is of significant clinical importance and an urgent need to
promote early recovery of myelosuppression and reduce risks of related complications as
well as medical burdens. Umbilical cord derived mesenchymal stem cells (UC-MSCs), as a
kind of stem cells with multipotential, can widely act on the functional cell units of
bone marrow microenvironment and promote the repairment and regeneration of key cells
such as hematopoietic stem cells, mesenchymal stem cells and endothelial cells, thus
making it an ideal means for effectively promoting recovery of myelosuppression. Patients
with hematologic malignancies and treatment-induced myelosuppression will be invited to
participate in the Phase Ib/II study, to receive UC-MSCs intravenous infusion and
follow-up visits of up to 2 years after enrollment.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Aged between 18 and 75 years old;
2. Either type of primary hematologic malignancies listed below:
1. 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;
2. AML or ALL participants who achieved remission and are going to receive
consolidation therapy;
3. Relapsed/refractory AML or ALL participants who are going to receive first
re-induction therapy;
4. 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;
3. 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;
4. Male or female;
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the
day anti-cancer therapy is initiated)
6. Estimated survival of at least 3 months;
7. Adequate major organ function:
1. Respiratory function: indoor oxygen saturation of at least 95%;
2. Cardiac function: ejection fraction of left ventricular of at least 45%;
3. 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;
4. Renal function: Serum creatinine of at most 1.5 times/upper limit of normal
value;
8. 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 therapy has recovered to
Grade 1 or below (except for low grade toxities such as alopecia).
Exclusion Criteria:
1. Overt central nervous system manifestations of hematologic malignancies at
diagnosis;
2. Secondary hematological maligancies;
3. Body mass index (BMI) of more than 30 kg/m^2;
4. Myelosuppression induced by conditions other than anti-cancer therapy;
5. Previous radiation therapy performed on sternum or pelvis;
6. Specifically diagnosed and uncontrolled infection at enrollment (Uncontrolled is
defined as exhibiting ongoing signs and symptoms of infection without improvement
despite anti-infective agents) ;
7. Uncontrolled active bleeding at enrollment;
8. Severe underlying comorbidities affecting survival, including cachexia, severe
malnutrition, etc;
9. Estimated survival of at most 48 hours;
10. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection;
11. History of or current human immunodeficiency virus (HIV) infection;
12. Continuous usage of immunosuppressants or received organ transplantation in the last
6 months;
13. Participation in clinical trials of other drugs within 6 weeks before enrollment;
14. Previous participation in clinical stem cell research;
15. Receiving any agent concurrently with UC-MSCs infusion which inhibits cell division
(hydroxyurea, low-dose cytarabine or methotrexate, etc) ;
16. Severe allergic constitution, or known or suspected allergy to the study drug and
its components;
17. Known contraindication to receiving hematopoietic growth factors, transfusion of
blood components, anti-infective agents;
18. Female participants who are pregnant or breast feeding;
19. Participants with fertility plan;
Note: 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 study and
within 6 months after the end of treatment period of the study; For male
participants, they should be surgical sterilized or agree to utilize a medically
recognised method of contraception (such as intrauterine device, condom) during
treatment period of the study and within 6 months after the end of treatment period
of the study;
20. Participants suffering from mental illness;
21. Presence of drug abuse/addiction;
22. History of other malignancies other than hematological malignancies within 3 years;
23. Participants without signed informed consent;
24. Participants with poor compliance and are unable to complete the whole course of the
study;
25. 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, sensitivity or cognitive
impairment, etc) ;
26. Participants with other circumstances that are ineligible for enrollment in this
study, in the opinion of the investigator.
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Wuhan Central Hospital
Address:
City:
Wuhan
Zip:
430014
Country:
China
Contact:
Last name:
Hongxiang Wang, Professor
Email:
whitely1972@sina.com
Investigator:
Last name:
Hongxiang Wang, Professor
Email:
Principal Investigator
Facility:
Name:
Wuhan Union Hospital
Address:
City:
Wuhan
Zip:
430022
Country:
China
Contact:
Last name:
Qiubai Li, Professor
Phone:
(027) 85726387
Email:
qiubaili@hust.edu.cn
Investigator:
Last name:
Qiubai Li, Professor
Email:
Principal Investigator
Facility:
Name:
Wuhan Tongji Hospital
Address:
City:
Wuhan
Zip:
430030
Country:
China
Contact:
Last name:
Yicheng Zhang, Professor
Email:
yczhang@tjh.tjmu.edu.cn
Investigator:
Last name:
Yicheng Zhang, Professor
Email:
Principal Investigator
Start date:
January 1, 2023
Completion date:
January 31, 2025
Lead sponsor:
Agency:
Wuhan Union Hospital, China
Agency class:
Other
Collaborator:
Agency:
Wuhan TongJi Hospital
Agency class:
Other
Collaborator:
Agency:
Wuhan Central Hospital
Agency class:
Other
Source:
Wuhan Union Hospital, China
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05672420
