Neutropenic EnterocolitisPhase 1/2NCT02145923
Effectiveness and Safety of MMSCs for Enhancing Hematopoietic Recovery and Prophylaxis of Neutropenic Enterocolitis
A Phase 1/2 study testing Peripheral blood stem cell mobilisation and collection, High-dose chemotherapy and Bone marrow derived allogeneic MMSCs infusion in people with Neutropenic Enterocolitis and Myeloablative Chemotherapy Induced Bone Marrow Aplasia, run by Burnasyan Federal Medical Biophysical Center at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Neutropenic Enterocolitis, Myeloablative Chemotherapy Induced Bone Marrow Aplasia
- What is being tested?
- Peripheral blood stem cell mobilisation and collection, High-dose chemotherapy and Bone marrow derived allogeneic MMSCs infusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteRussia
- Study dates
- May 2014to Dec 2016
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Russia1 site
State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia
Moscow, 123182
About this study
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.
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.
Read the 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.
- Being tested
- Peripheral blood stem cell mobilisation and collection, High-dose chemotherapy, Bone marrow derived allogeneic MMSCs infusion, Autologous peripheral blood stem cells infusion
- 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
- Medical subject headings
- Enterocolitis, Neutropenic, Hodgkin Disease, Anemia, Aplastic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood stem cell mobilisation and collectionProcedure or surgery
High-dose chemotherapyDrug
High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)
Bone marrow derived allogeneic MMSCs infusionDrug
Autologous peripheral blood stem cells infusionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Peripheral blood stem cell mobilisation and collection; Drug: High-dose chemotherapy; Drug: Bone marrow derived allogeneic MMSCs infusion; Procedure: Autologous peripheral blood stem cells infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Measured: 2 weeks after treatment
Secondary outcomes (4)
Time of hematopoietic recovery
Monitoring of time of hematopoietic recovery assessed by complete blood count
Measured: Follow up to completion (up to 3 months after treatment)
Neutropenic enterocolitis
Monitoring of frequency (number of participants) and severity of neutropenic enterocolitis during the study period
Measured: 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.
Measured: Follow up to completion (up to 3 months after treatment)
Transfusion needs
Monitoring of frequency (number of participants) of transfusion needs during neutropenic period
Measured: Follow up to completion (up to 3 weeks after treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2014 (estimated)
- Study startMay 2014
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neutropenic EnterocolitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Burnasyan Federal Medical Biophysical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zarui Simavonyan, Burnasyan Federal Medical Biophysical Center
- Investigators
- Zaryi Simavonyan, MD, Principal investigator, Burnasyan Federal Medical Biophysical CenterIlya I Eremin, MD, PhD, Principal investigator, Burnasyan Federal Medical Biophysical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02145923
- Sponsor's protocol ID
- RU-FMBC-05-01-14
- Status last verified
- Jun 2015
- First submitted
- 21 May 2014
- Last updated
- 10 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02145923
- Acronym / sponsor ID
- RU-FMBC-05-01-14
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Burnasyan Federal Medical Biophysical CenterOther government
- Study start
- May 2014
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 23 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| allogeneic MMSCs infusion | Other | Procedure: Peripheral blood stem cell mobilisation and collection, Drug: High-dose chemotherapy, Drug: Bone marrow derived allogeneic MMSCs infusion, Procedure: Autologous peripheral blood stem cells infusionSubjects 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood stem cell mobilisation and collection | Procedure or surgery | allogeneic MMSCs infusion |
| High-dose chemotherapyHigh-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme) | Drug | allogeneic MMSCs infusion |
| Bone marrow derived allogeneic MMSCs infusion | Drug | allogeneic MMSCs infusion |
| Autologous peripheral blood stem cells infusion | Procedure or surgery | allogeneic MMSCs infusion |
Primary outcome
Number of serious adverse events (SAEs) and serious adverse reactions (SARs)
Time frame: 2 weeks after treatment
4 secondary outcomes
Time of hematopoietic recovery
Time frame: Follow up to completion (up to 3 months after treatment)
Neutropenic enterocolitis
Time frame: Follow up to completion (up to 3 months after treatment)
Infectious complications
Time frame: Follow up to completion (up to 3 months after treatment)
Transfusion needs
Time frame: Follow up to completion (up to 3 weeks after treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zaryi Simavonyan, MD principal investigator
Burnasyan Federal Medical Biophysical Center
Ilya I Eremin, MD, PhD principal investigator
Burnasyan Federal Medical Biophysical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Peripheral blood stem cell mobilisation and collection, High-dose chemotherapy and Bone marrow derived allogeneic MMSCs infusion in people with Neutropenic Enterocolitis and Myeloablative Chemotherapy Induced Bone Marrow Aplasia, run by Burnasyan Federal Medical Biophysical Center at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of serious adverse events (SAEs) and serious adverse reactions (SARs) (time frame: 2 weeks after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2015.