NCT02145923

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2014

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 21, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

June 10, 2015

Status Verified

June 1, 2015

Enrollment Period

2.1 years

First QC Date

May 21, 2014

Last Update Submit

June 9, 2015

Conditions

Neutropenic EnterocolitisMyeloablative Chemotherapy Induced Bone Marrow Aplasia

Keywords

Hodgkin LymphomaNon-Hodgkin's LymphomasAllogeneic Mesenchymal Stem Cell TransplantationAutologous Peripheral Blood Stem Cell TransplantationNeutropenic EnterocolitisMyeloablative ChemotherapyBone Marrow Aplasia

Outcome Measures

Primary Outcomes (1)

  • Number of serious adverse events (SAEs) and serious adverse reactions (SARs)

    2 weeks after treatment

Secondary Outcomes (4)

  • Time of hematopoietic recovery

    Follow up to completion (up to 3 months after treatment)

  • Neutropenic enterocolitis

    Follow up to completion (up to 3 months after treatment)

  • Infectious complications

    Follow up to completion (up to 3 months after treatment)

  • Transfusion needs

    Follow up to completion (up to 3 weeks after treatment)

Study Arms (1)

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.

Procedure: Peripheral blood stem cell mobilisation and collectionDrug: High-dose chemotherapyDrug: Bone marrow derived allogeneic MMSCs infusionProcedure: Autologous peripheral blood stem cells infusion

Interventions

Peripheral blood stem cell mobilisation and collectionPROCEDURE
allogeneic MMSCs infusion
High-dose chemotherapyDRUG

High-dose chemotherapy will be performed according to protocols ICE and BEAM (standard scheme)

allogeneic MMSCs infusion
Bone marrow derived allogeneic MMSCs infusionDRUG
allogeneic MMSCs infusion
Autologous peripheral blood stem cells infusionPROCEDURE
allogeneic MMSCs infusion

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

State Research Center Burnasyan Federal Medical Biophysical Center FMBA of Russia

Moscow, 123182, Russia

Location

MeSH Terms

Conditions

Enterocolitis, NeutropenicHodgkin DiseaseAnemia, Aplastic

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

EnterocolitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal DiseasesLymphomaNeoplasms by Histologic TypeNeoplasmsLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesAnemiaHematologic DiseasesBone Marrow Failure DisordersBone Marrow Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Zaryi Simavonyan, MD

    Burnasyan Federal Medical Biophysical Center

    PRINCIPAL INVESTIGATOR

  • Ilya I Eremin, MD, PhD

    Burnasyan Federal Medical Biophysical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 21, 2014

First Posted

May 23, 2014

Study Start

May 1, 2014

Primary Completion

June 1, 2016

Study Completion

December 1, 2016

Last Updated

June 10, 2015

Record last verified: 2015-06

Locations

RU(1)