Clinical trial NCT02145923: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: 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
Lead sponsor: Burnasyan Federal Medical Biophysical Center
Sponsor class: OTHER_GOV
First posted: 2014-05-23
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
timeFrame: 2 weeks after treatment
Secondary outcomes:
measure: Time of hematopoietic recovery
timeFrame: Follow up to completion (up to 3 months after treatment)
measure: Neutropenic enterocolitis
timeFrame: Follow up to completion (up to 3 months after treatment)
measure: Infectious complications
timeFrame: Follow up to completion (up to 3 months after treatment)
measure: Transfusion needs
timeFrame: Follow up to completion (up to 3 weeks after treatment)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
Study officials:
affiliation: Burnasyan Federal Medical Biophysical Center
name: Zaryi Simavonyan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Burnasyan Federal Medical Biophysical Center
name: Ilya I Eremin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: