- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145923
Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis
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 Overview
Status
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.
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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Moscow, Russian Federation, 123182
- State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Other: allogeneic MMSCs infusion
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.
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High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Time Frame: 2 weeks after treatment
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2 weeks after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time of hematopoietic recovery
Time Frame: Follow up to completion (up to 3 months after treatment)
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Monitoring of time of hematopoietic recovery assessed by complete blood count
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Follow up to completion (up to 3 months after treatment)
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Neutropenic enterocolitis
Time Frame: Follow up to completion (up to 3 months after treatment)
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Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period
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Follow up to completion (up to 3 months after treatment)
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Infectious complications
Time Frame: Follow up to completion (up to 3 months after treatment)
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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.
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Follow up to completion (up to 3 months after treatment)
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Transfusion needs
Time Frame: Follow up to completion (up to 3 weeks after treatment)
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Monitoring of frequency (number of participants) of transfusion needs during neutropenic period
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Follow up to completion (up to 3 weeks after treatment)
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Collaborators and Investigators
Investigators
- Principal Investigator: Zaryi Simavonyan, MD, Burnasyan Federal Medical Biophysical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RU-FMBC-05-01-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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