Back to resultsEffectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis
Primary Purpose
Neutropenic Enterocolitis, Myeloablative Chemotherapy Induced Bone Marrow Aplasia
Status
Unknown status
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Peripheral blood stem cell mobilisation and collection
High-dose chemotherapy
Bone marrow derived allogeneic MMSCs infusion
Autologous peripheral blood stem cells infusion
Sponsored by
About this trial
This is an interventional prevention trial for Neutropenic Enterocolitis focused on measuring Hodgkin Lymphoma, Non-Hodgkin's Lymphomas, Allogeneic Mesenchymal Stem Cell Transplantation, Autologous Peripheral Blood Stem Cell Transplantation, Neutropenic Enterocolitis, Myeloablative Chemotherapy, Bone Marrow Aplasia
Eligibility Criteria
Inclusion Criteria:
- Patient suffers from Hodgkin's lymphoma, non-Hodgkin's lymphoma with complete or partial remission.
- Patient is candidate to high-dose chemotherapy with subsequent autologous hematopoietic stem cell transplantation.
- Absence of infection, cardiovascular, respiratory, renal and hepatic dysfunctions, focal neurological symptoms.
- Karnofsky score at least 70.
- Patient successfully undergone mobilization of peripheral blood stem cells.
- Patient is familiar with Participant information sheet.
- Patient signed informed consent form.
Non-inclusion Criteria:
- Severe chronic comorbidity with symptoms of organ or system failure.
- Significant abnormalities in laboratory tests.
- Participation in other clinical trials (or intake of study drugs) within prior 3 months.
- Conditions restricting commitment to participating in the trial (dementia, neuropsychiatric disorders, drug and alcohol abuse)
- Patients with malignant solid tumors.
- Patients with medical history of heterotopic ossification.
Exclusion Criteria:
- Progression or relapse of lymphoma during therapy.
- Confirmed syphilis, HIV, hepatitis B or C infection
- Absence of clinical and laboratory signs of hematopoietic recovery and persistent enterocolitis at day 14 after the manipulation (Visit 15). While the patient remains in the hospital and continues treatment according to requirements of standard therapy
Sites / Locations
- State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
allogeneic MMSCs infusion
Arm Description
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion.
Outcomes
Primary Outcome Measures
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Secondary Outcome Measures
Time of hematopoietic recovery
Monitoring of time of hematopoietic recovery assessed by complete blood count
Neutropenic enterocolitis
Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period
Infectious complications
Monitoring of frequency and severity of infectious complications during the study period. Frequency of infectious complications will be represented in number of infections verified by clinical, instrumental examination and/or laboratory methods.
Transfusion needs
Monitoring of frequency (number of participants) of transfusion needs during neutropenic period
Full Information
NCT ID
NCT02145923
First Posted
May 21, 2014
Last Updated
June 9, 2015
Sponsor
Burnasyan Federal Medical Biophysical Center
1. Study Identification
Unique Protocol Identification Number
NCT02145923
Brief Title
Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis
Official Title
Effectiveness and Safety of Intravenous Infusion of Bone Marrow Derived Allogeneic Multipotent Mesenchymal Stromal Cells for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis in Hematological Patients With Aplasia After High-dose Chemotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Unknown status
Study Start Date
May 2014 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Burnasyan Federal Medical Biophysical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion. This is a single arm study with no control. All patients receive cell therapy.
Detailed Description
Patients with verified diagnosis Hodgkin's lymphoma or non-Hodgkin's lymphoma will undergo peripheral blood stem cell mobilisation and collection (chemotherapy + G-CSF or G-CSF+Plerixafor).
After that high-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme).
Patient will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells infusion 48 hours after last administration of cytotoxic agent . Number of cells calculated according to patient's body weight (1,5-2,0 mln of cells/kg), time of infusion - 30 minutes. Two hours later patient will receive autologous peripheral blood cells infusion.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neutropenic Enterocolitis, Myeloablative Chemotherapy Induced Bone Marrow Aplasia
Keywords
Hodgkin Lymphoma, Non-Hodgkin's Lymphomas, Allogeneic Mesenchymal Stem Cell Transplantation, Autologous Peripheral Blood Stem Cell Transplantation, Neutropenic Enterocolitis, Myeloablative Chemotherapy, Bone Marrow Aplasia
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
16 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
allogeneic MMSCs infusion
Arm Type
Other
Arm Description
Subjects will undergo peripheral blood stem cell mobilisation and collection with subsequent high-dose chemotherapy. After finalization of high-dose chemotherapy subjects will receive bone marrow derived allogeneic multipotent mesenchymal stromal cells intravenous infusion two hours prior to autologous peripheral blood cells infusion.
Intervention Type
Procedure
Intervention Name(s)
Peripheral blood stem cell mobilisation and collection
Intervention Type
Drug
Intervention Name(s)
High-dose chemotherapy
Intervention Description
High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)
Intervention Type
Drug
Intervention Name(s)
Bone marrow derived allogeneic MMSCs infusion
Intervention Type
Procedure
Intervention Name(s)
Autologous peripheral blood stem cells infusion
Primary Outcome Measure Information:
Title
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Time Frame
2 weeks after treatment
Secondary Outcome Measure Information:
Title
Time of hematopoietic recovery
Description
Monitoring of time of hematopoietic recovery assessed by complete blood count
Time Frame
Follow up to completion (up to 3 months after treatment)
Title
Neutropenic enterocolitis
Description
Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period
Time Frame
Follow up to completion (up to 3 months after treatment)
Title
Infectious complications
Description
Monitoring of frequency and severity of infectious complications during the study period. Frequency of infectious complications will be represented in number of infections verified by clinical, instrumental examination and/or laboratory methods.
Time Frame
Follow up to completion (up to 3 months after treatment)
Title
Transfusion needs
Description
Monitoring of frequency (number of participants) of transfusion needs during neutropenic period
Time Frame
Follow up to completion (up to 3 weeks after treatment)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient suffers from Hodgkin's lymphoma, non-Hodgkin's lymphoma with complete or partial remission.
Patient is candidate to high-dose chemotherapy with subsequent autologous hematopoietic stem cell transplantation.
Absence of infection, cardiovascular, respiratory, renal and hepatic dysfunctions, focal neurological symptoms.
Karnofsky score at least 70.
Patient successfully undergone mobilization of peripheral blood stem cells.
Patient is familiar with Participant information sheet.
Patient signed informed consent form.
Non-inclusion Criteria:
Severe chronic comorbidity with symptoms of organ or system failure.
Significant abnormalities in laboratory tests.
Participation in other clinical trials (or intake of study drugs) within prior 3 months.
Conditions restricting commitment to participating in the trial (dementia, neuropsychiatric disorders, drug and alcohol abuse)
Patients with malignant solid tumors.
Patients with medical history of heterotopic ossification.
Exclusion Criteria:
Progression or relapse of lymphoma during therapy.
Confirmed syphilis, HIV, hepatitis B or C infection
Absence of clinical and laboratory signs of hematopoietic recovery and persistent enterocolitis at day 14 after the manipulation (Visit 15). While the patient remains in the hospital and continues treatment according to requirements of standard therapy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zaryi Simavonyan, MD
Organizational Affiliation
Burnasyan Federal Medical Biophysical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ilya I Eremin, MD, PhD
Organizational Affiliation
Burnasyan Federal Medical Biophysical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis
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