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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| allogeneic MMSCs infusion | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peripheral blood stem cell mobilisation and collection | Procedure |
| ||
| High-dose chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Number of serious adverse events (SAEs) and serious adverse reactions (SARs) | 2 weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Time of hematopoietic recovery | Monitoring of time of hematopoietic recovery assessed by complete blood count | Follow up to completion (up to 3 months after treatment) |
| Neutropenic enterocolitis |
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Inclusion Criteria:
Non-inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Zaryi Simavonyan, MD | Burnasyan Federal Medical Biophysical Center | Principal Investigator |
| Ilya I Eremin, MD, PhD | Burnasyan Federal Medical Biophysical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia | Moscow | 123182 | Russia |
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| Drug |
High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme) |
|
| Bone marrow derived allogeneic MMSCs infusion | Drug |
|
| Autologous peripheral blood stem cells infusion | Procedure |
|
Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period
| Follow up to completion (up to 3 months after treatment) |
| 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. | Follow up to completion (up to 3 months after treatment) |
| Transfusion needs | Monitoring of frequency (number of participants) of transfusion needs during neutropenic period | Follow up to completion (up to 3 weeks after treatment) |
| ID | Term |
|---|---|
| D044504 | Enterocolitis, Neutropenic |
| D006689 | Hodgkin Disease |
| D000741 | Anemia, Aplastic |
| ID | Term |
|---|---|
| D004760 | Enterocolitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D000080983 | Bone Marrow Failure Disorders |
| D001855 | Bone Marrow Diseases |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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