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Status unknownNCT02270307MSC-CYUpdated Oct 21, 2014

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

A Phase 2/3 interventional study of Cyclophosphamide and Mesenchymal stromal cells in Leukemia and Multiple Myeloma, sponsored by National Research Center for Hematology, Russia. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2014-10-21.

Sponsored by National Research Center for Hematology, Russia · Phase 2/3, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2/3
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Leukemia
  • Multiple Myeloma

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03

In context

Multiple Myeloma

3,632 studies on the registry are indexed under Multiple Myeloma; 745 are open to participants now.

This study's planned enrollment of 40 is close to the median of 41 across 2,907 interventional studies indexed under Multiple Myeloma.

Browse Multiple Myeloma studies →

Lead sponsor

National Research Center for Hematology, Russia is the lead sponsor of 21 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • ICU
  • Mechanical ventilation
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Study design

Phase
Phase 2 / Phase 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    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

    Drug: Cyclophosphamide · Biological: Mesenchymal stromal cells

Interventions

  • DrugCyclophosphamide

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

  • BiologicalMesenchymal stromal cells

    Dose 1 million per kg, at day of recovery once

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What researchers measure

Primary outcomes

  1. Overall survival

    Time frame: 1 year

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Study locations

1 of 1 sites recruiting
  • BMT department
    Moscow, Russian Federation
    • Elena Parovichnikova, Prof MD PhD · Contact · kuzlara@rambler.ru · +79161487131
    • Elena Parovichnikova · Principal investigator
    Recruiting
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 21, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02270307
Lead sponsor
National Research Center for Hematology, Russia
Responsible party
Elena N.Parovichnikova (PI, National Research Center for Hematology, Russia) — Principal investigator
First posted
Oct 21, 2014
Start date
Jan 2014
Primary completion
Jan 2016 (estimated)
Completion
Jan 2016 (estimated)
Last update
Oct 21, 2014

Study contacts

Elena N Parovichnikova, PhD,MD
Contact
elenap@blood.ru
+79161252623
Mikhail Y Drokov, PhD,MD
Contact
mdrokov@gmail.com
+79261841813
Valery Savchenko, Prof.
study director · Ministry of Health

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.

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