NCT02270307

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.

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
40

participants targeted

Target at P50-P75 for phase_2 leukemia

Timeline
Completed

Started Jan 2014

Shorter than P25 for phase_2 leukemia

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

January 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2014

Completed
7 months until next milestone

First Posted

Study publicly available on registry

October 21, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

October 21, 2014

Status Verified

October 1, 2014

Enrollment Period

2 years

First QC Date

April 7, 2014

Last Update Submit

October 17, 2014

Conditions

LeukemiaMultiple Myeloma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    1 year

Study Arms (1)

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: CyclophosphamideBiological: Mesenchymal stromal cells

Interventions

CyclophosphamideDRUG

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

MSC+CY
Mesenchymal stromal cellsBIOLOGICAL

Dose 1 million per kg, at day of recovery once

MSC+CY

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

  • ICU
  • Mechanical ventilation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BMT department

Moscow, Russia

RECRUITING

MeSH Terms

Conditions

LeukemiaMultiple Myeloma

Interventions

Cyclophosphamide

Condition Hierarchy (Ancestors)

Neoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms, Plasma CellHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System Diseases

Intervention Hierarchy (Ancestors)

Phosphoramide MustardsNitrogen Mustard CompoundsMustard CompoundsHydrocarbons, HalogenatedHydrocarbonsOrganic ChemicalsPhosphoramidesOrganophosphorus Compounds

Study Officials

  • Valery Savchenko, Prof.

    Ministry of Health

    STUDY DIRECTOR

Central Study Contacts

Elena N Parovichnikova, PhD,MD

CONTACT

+79161252623elenap@blood.ru

Mikhail Y Drokov, PhD,MD

CONTACT

+79261841813mdrokov@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NETWORK
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

April 7, 2014

First Posted

October 21, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

October 21, 2014

Record last verified: 2014-10

Locations

RU(1)