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

NCT ID: NCT02270307

Last Updated: 2014-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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.

Conditions

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Leukemia Multiple Myeloma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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MSC+CY

Cyclophosphamide 50 mg/kg/day at +3, +4 day once daily after BMT Mesenchymal stromal cells 1\*10\^6/kg at day of recovery

Group Type EXPERIMENTAL

Cyclophosphamide

Intervention Type DRUG

Dose 50 mg/kg at day +3,+4 once daily

Mesenchymal stromal cells

Intervention Type BIOLOGICAL

Dose 1 million per kg, at day of recovery once

Interventions

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Cyclophosphamide

Dose 50 mg/kg at day +3,+4 once daily

Intervention Type DRUG

Mesenchymal stromal cells

Dose 1 million per kg, at day of recovery once

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Research Center for Hematology, Russia

NETWORK

Sponsor Role lead

Responsible Party

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Elena N.Parovichnikova

PI

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Valery Savchenko, Prof.

Role: STUDY_DIRECTOR

Ministry of Health

Locations

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BMT department

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Elena N Parovichnikova, PhD,MD

Role: CONTACT

+79161252623

Mikhail Y Drokov, PhD,MD

Role: CONTACT

+79261841813

Facility Contacts

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Elena Parovichnikova, Prof MD PhD

Role: primary

+79161487131

Other Identifiers

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MSC-CY-Russia

Identifier Type: -

Identifier Source: org_study_id

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