MSC and Cyclophosphamide for Acute Graft-Versus-Host Dise... | NCT02270307

Studies
MSC and Cyclophosphamide for Acute Graft-Versus-Host Disease (aGVHD) Prophylaxis

NCT02270307

Sponsor

National Research Center for Hematology, Russia

Status

Unknown status

Last Update Posted

Oct 21, 2014Estimated

Enrollment

40Estimated

Phase

Phase 2Phase 3

Conditions

Leukemia
Multiple Myeloma

Interventions

Cyclophosphamide
Mesenchymal stromal cells

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

Allogeneic Bone Marrow Transplantation (Allo-BMT) From Human Leukocyte Antigen (HLA) - Identical Related and Unrelated Donors in Patients With Hematological Malignancies With High Risk of Relapse Using Cyclophosphamide (CY) and Mesenchymal Stromal Cells (MSC) as aGVHD Prophylaxis

Status Module

Record Verification Date

Oct 2014

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Jan 2016Estimated

Completion Date

Jan 2016Estimated

First Submitted Date

Apr 7, 2014

First Submission Date that Met QC Criteria

Oct 17, 2014

First Posted Date

Oct 21, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 17, 2014

Last Update Posted Date

Oct 21, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Elena N.Parovichnikova, PI, National Research Center for Hematology, RussiaPrincipal Investigator

Lead Sponsor

National Research Center for Hematology, RussiaNETWORK

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Detailed Description

This trial try to find a new way of refractory hematological malignancies treatment. Aim of this study evaluating the effectiveness of the new protocol which replace the standard immunosuppressive therapy with use of MSCs and CY in patients at high risk of relapse.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
MSC+CY	Experimental	Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1*10^6/kg at day of recovery	Drug: Cyclophosphamide Biological: Mesenchymal stromal cells

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cyclophosphamide	Drug	Dose 50 mg/kg at day +3,+4 once daily	MSC+CY

Measure	Description	Time Frame
Overall survival		1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Refractory forms of acute leukemia, but in complete remission (CR)
Second and third remission of acute leukemia
2nd and 3rd chronic phase chronic myelogenous leukemia (CML) (or Ph + ALL)
relapsed multiple myeloma
advanced leukemia

Exclusion Criteria:

ICU
Mechanical ventilation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Elena N Parovichnikova, PhD,MD	Contact	+79161252623		elenap@blood.ru
Mikhail Y Drokov, PhD,MD	Contact	+79261841813		mdrokov@gmail.com

Overall Officials

Name	Affiliation	Role
Valery Savchenko, Prof.	Ministry of Health	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BMT department	Recruiting	Moscow			Russia

Condition Browse Module

MeSH Terms

ID	Term
D007938	Leukemia
D009101	Multiple Myeloma

Ancestor Terms

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003520	Cyclophosphamide

Ancestor Terms

ID	Term
D010752	Phosphoramide Mustards
D009588	Nitrogen Mustard Compounds
D009150	Mustard Compounds
D006846	Hydrocarbons, Halogenated

Browse Leaves

Not provided

Browse Branches

Not provided