NCT02452099

Brief Summary

The main aim of the study was to evaluate the clinical impact of different DMSO concentrations in cryopreservation mixture (5%, 7.5%, 10%) on reconstitution of hematopoiesis after autologous hematopoietic stem cell transplantation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
150

participants targeted

Target at P75+ for not_applicable multiple-myeloma

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 20, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

2.6 years

First QC Date

May 20, 2015

Last Update Submit

January 17, 2017

Conditions

Multiple MyelomaLymphomasLeukemias

Keywords

DMSOcryopreservationautologous transplantationhematopoietic stem cellshematological malignancies

Outcome Measures

Primary Outcomes (1)

  • The median time to neutrophils recovery after autoHSC transplantation.

    The first from 3 consecutive days, on which absolute neutrophil count in peripheral blood will be higher than 0.5 G/L

Secondary Outcomes (2)

  • The median time to platelets recovery after autoHSC transplantation.

    The first from 3 consecutive days, on which platelet count in peripheral blood will be higher than 20 G/L, without platelet transfusion 7 days prior.

  • Adverse reactions related with transplantation procedure

    24 hours after transplantation

Study Arms (3)

5% DMSO

OTHER
Procedure: Cryopreservation of HSCs using 5% DMSO concentration

7.5% DMSO

OTHER
Procedure: Cryopreservation of HSCs using 7,5% DMSO concentration

10% DMSO

OTHER
Procedure: Cryopreservation of HSCs using 10% DMSO concentration

Interventions

Cryopreservation of HSCs using 5% DMSO concentrationPROCEDURE

Cryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration.

5% DMSO
Cryopreservation of HSCs using 7,5% DMSO concentrationPROCEDURE

Cryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration.

7.5% DMSO
Cryopreservation of HSCs using 10% DMSO concentrationPROCEDURE

Cryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration.

10% DMSO

Eligibility Criteria

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

You may qualify if:

  • Patients with hematological malignancies or solid tumors, refered for autologous HSC transplantation
  • Written informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

MSC Memorial CAncer Center and Institute of Oncology

Gliwice, 44-101, Poland

Location

Related Publications (3)

  • Smagur A, Mitrus I, Ciomber A, Panczyniak K, Fidyk W, Sadus-Wojciechowska M, Holowiecki J, Giebel S. Comparison of the cryoprotective solutions based on human albumin vs. autologous plasma: its effect on cell recovery, clonogenic potential of peripheral blood hematopoietic progenitor cells and engraftment after autologous transplantation. Vox Sang. 2015 May;108(4):417-24. doi: 10.1111/vox.12238. Epub 2015 Mar 6.

    PMID: 25753814RESULT

  • Mitrus I, Smagur A, Giebel S, Gliwinska J, Prokop M, Glowala-Kosinska M, Chwieduk A, Sadus-Wojciechowska M, Tukiendorf A, Holowiecki J. A faster reconstitution of hematopoiesis after autologous transplantation of hematopoietic cells cryopreserved in 7.5% dimethyl sulfoxide if compared to 10% dimethyl sulfoxide containing medium. Cryobiology. 2013 Dec;67(3):327-31. doi: 10.1016/j.cryobiol.2013.09.167. Epub 2013 Oct 11.

    PMID: 24125911RESULT

  • Smagur A, Mitrus I, Giebel S, Sadus-Wojciechowska M, Najda J, Kruzel T, Czerw T, Gliwinska J, Prokop M, Glowala-Kosinska M, Chwieduk A, Holowiecki J. Impact of different dimethyl sulphoxide concentrations on cell recovery, viability and clonogenic potential of cryopreserved peripheral blood hematopoietic stem and progenitor cells. Vox Sang. 2013 Apr;104(3):240-7. doi: 10.1111/j.1423-0410.2012.01657.x. Epub 2012 Oct 9.

    PMID: 23046417RESULT

MeSH Terms

Conditions

Multiple MyelomaLymphomaLeukemiaHematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms, Plasma CellNeoplasms by Histologic TypeNeoplasmsHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemorrhagic DisordersLymphoproliferative DisordersImmunoproliferative DisordersImmune System DiseasesLymphatic DiseasesNeoplasms by Site

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof., MD

Study Record Dates

First Submitted

May 20, 2015

First Posted

May 22, 2015

Study Start

January 1, 2014

Primary Completion

August 1, 2016

Study Completion

December 1, 2016

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

PL(1)