A Multicenter, Open-label, Randomized, Phase I/II Clinical Trial Comparing Safety and Durable Overall Response Day 56 in Patients With Steroid Resistent Acute GvHD After Allogeneic Hematopoietic Stem Cell Transplant Treated With DSC or BAT

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease in the second part of the study. Patients will receive 2 doses of DSC. Additional doses (up to 4 doses) may be given depending on response. No cross-over are planned in the second stage of the study.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT.

• Signed written study informed consent once SR-aGvHD is confirmed.

Locations
Other Locations
Denmark
Copenhagen Univerity Hospital
RECRUITING
Copenhagen
Norway
Oslo University Hospital
RECRUITING
Oslo
Sweden
Gothenburg University Hospital
WITHDRAWN
Gothenburg
Lund University Hospital
RECRUITING
Lund
Karolinska University Hospital
WITHDRAWN
Stockholm
Uppsala University Hospital
RECRUITING
Uppsala
Contact Information
Primary
Mats Remberger, Professor
mats.remberger@akademiska.se
+46-760165080
Backup
Ulla Olsson-Strömberg, AssProfessor
ulla.olsson.stromberg@akademiska.se
+46-709522667
Time Frame
Start Date: 2021-12-01
Estimated Completion Date: 2031-12-31
Participants
Target number of participants: 50
Treatments
Experimental: Decidua Stroma Cells (DSC)
Placenta derived decidua stroma cells (DSC). In the first phase I part, two different dose levels will be used, 1x10\^6/kg and 3x10\^6/kg. Two doses, one week apart, will be given. The decision to proceed to the next dose level will depend on results observed at the previous dose level.~The dose in the randomized part will be based on the findings in the phase I part. In the Phase II study all patients will receive 2 doses, one week apart. Depending on response, up to 6 doses in total may be given. Additional doses (beyond the first 2 doses) may be given one week apart until response.
Active_comparator: Best Available Treatment (BAT)
The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, vedolizumab, ruxolitinib or infliximab. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT.
Sponsors
Leads: Mats Remberger
Collaborators: The Swedish Research Council

This content was sourced from clinicaltrials.gov