Neutropenic Enterocolitis, Myeloablative Chemotherapy Induced Bone Marrow Aplasia
Conditions
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
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.
Interventions
PROCEDUREPeripheral blood stem cell mobilisation and collection
High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)
DRUGBone marrow derived allogeneic MMSCs infusion
PROCEDUREAutologous peripheral blood stem cells infusion
Sponsors
Burnasyan Federal Medical Biophysical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of serious adverse events (SAEs) and serious adverse reactions (SARs) | 2 weeks after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time of hematopoietic recovery | Follow up to completion (up to 3 months after treatment) | Monitoring of time of hematopoietic recovery assessed by complete blood count |
| Neutropenic enterocolitis | Follow up to completion (up to 3 months after treatment) | Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period |
| Infectious complications | Follow up to completion (up to 3 months after treatment) | 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 | Follow up to completion (up to 3 weeks after treatment) | Monitoring of frequency (number of participants) of transfusion needs during neutropenic period |
Countries
Russia
Outcome results
None listed