NCT05672420

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
181

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2023

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 1, 2023

Completed
Same day until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

January 5, 2023

Status Verified

January 1, 2023

Enrollment Period

12 months

First QC Date

January 1, 2023

Last Update Submit

January 3, 2023

Conditions

Hematologic NeoplasmsNeutropeniaAnemiaThrombocytopeniaInfectionsBleeding

Keywords

umbilical cord derived mesenchymal stem cellstreatment-induced myelosuppressionneutropeniaanemiathrombocytopeniainfectionsbleedinghematologic malignanciesleukemialymphomamultiple myelomachemotherapytargeted therapyhematopoietic stem cell transplantation

Outcome Measures

Primary Outcomes (3)

  • Dose-limiting toxicities（DLT)

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

    4 days after the last UC-MSCs dose, up to 12 days

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

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

    From the day that the last UC-MSCs dose is used to up to 21 days

  • Maximum tolerated dose (MTD)

    During the dose-escalation phase, the highest dose of dose-limiting toxicity for subjects less than or equal to 1/3 in the dose group of at least 6 evaluble subjects of the study drug after the last UC-MSCs dose.

    From the day that the last UC-MSCs dose is used to up to 4 days

Secondary Outcomes (20)

  • Time to absolute neutrophil count recovery

    From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days

  • Incidence of febrile neutropenia

    From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days

  • Duration of febrile neutropenia

    From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days

  • Incidence of severe thrombocytopenia

    From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days

  • Time to severe thrombocytopenia recovery

    From the start of anti-cancer therapy or completion of hematopoietic stem cell transplantation to up to 42 days

  • +15 more secondary outcomes

Study Arms (1)

umbilical cord derived mesenchymal stem cells (UC-MSCs)

EXPERIMENTAL

In the Phase Ib study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia, UC-MSCs will be preset with 5 escalation dose levels: dose A , dose B, dose C ,dose D and dose E, frequency of infusion will be preset with 3 escalation levels: frequency 1, frequency 2, frequency 3, total course of treatment: 2 weeks; In the Phase II study, participants will be those with treatment-induced myelosuppression and acute myeloid leukemia/acute lymphoblastic leukemia/primary hematological maligancies who are going to receive hematopoietic stem cell transplantation, UC-MSCs will be preset according to the recommended phase II dose (RP2D) from the Phase Ib study, total course of treatment: 2 weeks.

Biological: umbilical cord derived mesenchymal stem cells

Interventions

umbilical cord derived mesenchymal stem cellsBIOLOGICAL

umbilical cord derived mesenchymal stem cells, intravenous infusion

umbilical cord derived mesenchymal stem cells (UC-MSCs)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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;
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 to 2 (by the day anti-cancer therapy 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;
  • +1 more criteria

You may not qualify if:

  • Overt central nervous system manifestations of hematologic malignancies at diagnosis;
  • Secondary hematological maligancies;
  • 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;
  • 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;
  • 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 research;
  • Receiving any agent concurrently with UC-MSCs infusion which inhibits cell division (hydroxyurea, low-dose cytarabine or methotrexate, etc) ;
  • +12 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Wuhan Central Hospital

Wuhan, Hubei, 430014, China

Location

Wuhan Union Hospital

Wuhan, Hubei, 430022, China

Location

Wuhan Tongji Hospital

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Hematologic NeoplasmsNeutropeniaAnemiaThrombocytopeniaInfectionsHemorrhageLeukemiaLymphomaMultiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesAgranulocytosisLeukopeniaCytopeniaLeukocyte DisordersBlood Platelet DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic Disorders

Study Officials

  • Qiubai Li, Professor

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

    STUDY DIRECTOR

Central Study Contacts

Qiubai Li, Professor

CONTACT

(027) 85726387qiubaili@hust.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D. & Ph.D., Professor

Study Record Dates

First Submitted

January 1, 2023

First Posted

January 5, 2023

Study Start

January 1, 2023

Primary Completion

December 31, 2023

Study Completion

January 31, 2025

Last Updated

January 5, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CN(3)