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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Multiple Myeloma, Lymphomas, Leukemias

Intervention / Treatment
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* 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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with hematological malignancies or solid tumors, refered for autologous HSC transplantation Written informed consent

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 5% DMSO<br> | Procedure: Cryopreservation of HSCs using 5% DMSO concentration<br>* Cryopreservation of HSCs obtained by leukapheresis will be performed using 5% DMSO concentration.<br>|
| Other: 7.5% DMSO<br> | Procedure: Cryopreservation of HSCs using 7,5% DMSO concentration<br>* Cryopreservation of HSCs obtained by leukapheresis will be performed using 7,5% DMSO concentration.<br>|
| Other: 10% DMSO<br> | Procedure: Cryopreservation of HSCs using 10% DMSO concentration<br>* Cryopreservation of HSCs obtained by leukapheresis will be performed using 10% DMSO concentration.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DMSO, cryopreservation, autologous transplantation, hematopoietic stem cells, hematological malignancies