DMSOconc3: Impact of DMSO Concentrations on Hematopoietic Recovery After Autologous HSC Transplantation.

Sponsor

Maria Sklodowska-Curie National Research Institute of Oncology (Other)

Overall Status

Completed

CT.gov ID

NCT02452099

Collaborator

(none)

150

Enrollment

Location

Arms

Duration (Months)

4.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Myeloma Lymphomas Leukemias	Procedure: Cryopreservation of HSCs using 5% DMSO concentration Procedure: Cryopreservation of HSCs using 7,5% DMSO concentration Procedure: Cryopreservation of HSCs using 10% DMSO concentration	N/A

Detailed Description

The procedure of autologous hematopoietic stem cell (HSC) transplantation requires cryopreservation of HSCs. Addition of DMSO (dimethyl sulfoxide) is necessary to secure the viability of such cells, but this cryoprotectant is potentially toxic to stem cell recipient. The concentrations of DMSO in cryopreservation mixture vary strongly between protocols in different transplant centers. Usually, the HSCs are stored in mixtures containing 10% DMSO, but there is no sufficient evidence that this concentration of DMSO is indeed optimal.

The main aim of the study is to evaluate the clinical impact of reduction of DMSO concentration in cryopreservation mixture on engraftment after autologous hematopoietic stem cell transplantation. 150 consecutive patients will be randomly assigned to one of three study arms (50 patients each). HSCs obtained by leukapheresis will be cryopreserved in three concentrations of DMSO: 5%, 7.5%, 10%, respectively. Evaluation of the mixtures will be carried out by monitoring reconstitution of hematopoiesis and the frequency the side effects in patients. The most important aspect of our evaluation will be the speed of neutrophil recovery after transplantation (defined by the first day, when absolute neutrophil count in peripheral blood will be higher than 0.5 G/L). The investigators will also evaluate the toxicity of cell suspension by monitoring the frequency of infusion-related adverse events (like nausea or vomiting) during infusion and 24 hours after transplantation.

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Impact of Different DMSO Concentrations in Cryopreservation Mixture on Hematopoietic Recovery After Autologous Transplantation of Hematopoietic Stem Cells.

Study Start Date :

Jan 1, 2014

Actual Primary Completion Date :

Aug 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Other: 5% DMSO	Procedure: Cryopreservation of HSCs using 5% DMSO concentration Cryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration.
Other: 7.5% DMSO	Procedure: Cryopreservation of HSCs using 7,5% DMSO concentration Cryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration.
Other: 10% DMSO	Procedure: Cryopreservation of HSCs using 10% DMSO concentration Cryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration.

Arm

Intervention/Treatment

Other: 5% DMSO

Procedure: Cryopreservation of HSCs using 5% DMSO concentration

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

Other: 7.5% DMSO

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

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

Other: 10% DMSO

Procedure: Cryopreservation of HSCs using 10% DMSO concentration

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

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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]