Clinical Trials Logo
  1. Home
  2. GVHD
  3. NCT02490163

Comparison of Two Automated Mononuclear Collection Systems in Patients Undergoing Extracorporeal Photochemotherapy. A Cross-over Equivalence Study. (MNC_CMNC) — CMNC_MNC  

GvHD Clinical Trial

Official title:
Comparison of Two Automated Mononuclear Collection Systems (Spectra Optia CMNC and MNC) in Patients Undergoing Extracorporeal Photochemotherapy. A Cross-over Equivalence Study.

Clinical Trial Summary

In a study performed in 2012, the investigators demonstrated that in ECP setting , the new automated device (Spectra Optia-MNC) released by Terumo BCT for MNCs collection based on intermittent flow is safe and ensures high-quality MNC collection and yield.(5, 6) More recently (in 2013), Terumo BCT released another automated system that allows to collect stem cells and MNCs basing on a continuous collection flow.(7, 8) The aim of this cross-over study is to compare yield (i.e. collection efficiency, CE) and quality (i.e. purity and contamination) of MNCs collected from patients undergoing ECP with two different automated systems: MNC and CMNC (Terumo BCT) processing 1.5 blood volumes during every collection procedure.

Clinical Trial Description

Two-sequences-in-four-periods cross-over, with the same patients randomized to both devices within each ECP cycle in two consecutive cycles, open-label.

Cycle 1 Cycle 1 Cycle 2 Cycle 2 Day 1 Day 2 Day 1 Day 2 Sequence A CMNC MNC MNC CMNC Sequence B MNC CMNC CMNC MNC There might be some carry over effect between procedure 1 and 2 within each cycle, because during the procedure the patient is administered fluids, and therefore cell counts/ml in the second day might be lower than in the first day; this it is intrinsic to the clinical procedure and can not be modified, but will be taken into account in statistical analyses. Carry over effect between first and second cycle is not expected, since they are performed at least 7 days apart; this allow the patient's cell blood count to be restored to baseline values; however, this will also be considered in statistical analyses. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02490163
Study type Interventional
Source IRCCS Policlinico S. Matteo
Contact
Status Completed
Phase Phase 3
Start date August 2015
Completion date January 2016
View Details
See also
  Status Clinical Trial Phase
Completed NCT02942173 - CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT Phase 2/Phase 3
Completed NCT02066051 - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD N/A
Terminated NCT01940796 - Phase I Trial of Brentuximab Vedotin for Refractory Chronic Graft-vs.-Host Disease (GVHD) Phase 1
Not yet recruiting NCT05544448 - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases N/A
Completed NCT01295710 - Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD) Phase 3
Not yet recruiting NCT06075225 - MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib Phase 2
Not yet recruiting NCT06000982 - Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis Phase 3
Active, not recruiting NCT03680092 - Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation Phase 2
Not yet recruiting NCT06083129 - Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor Phase 3
Not yet recruiting NCT05094765 - Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD Early Phase 1
Active, not recruiting NCT05415410 - Proof-of-concept Trial of Apraglutide in GVHD Phase 2
Completed NCT02441075 - 70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014 N/A
Completed NCT02588339 - Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention Phase 2
Not yet recruiting NCT06334367 - Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT Phase 2
Completed NCT03846479 - Itacitinib for Low Risk GVHD Phase 2
Completed NCT02891603 - A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression Phase 1/Phase 2
Completed NCT02712762 - Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients
Completed NCT03945591 - High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Phase 2
Not yet recruiting NCT06411184 - Safety and Efficacy of Treg Cell in the Treatment of GVHD Phase 1/Phase 2
Terminated NCT02338232 - Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation N/A