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NCT03263767: CYRIC

Post Transplant Cyclophosphamide (PTCY) as Sole Graft Versus Host Disease (GVHD) Prophylaxis for Matched Allotransplant: CYRIC

Terminated Phase 2 Last updated 15 July 2022
What this trial tests

Phase 2 trial testing Fludarabine in Graft Versus Host Disease in 47 participants. Terminated before completion.

Timeline
15 January 2018
Primary endpoint
21 October 2021
21 June 2022

Quick facts

Lead sponsorNantes University Hospital
PhasePhase 2
StatusTerminated
Study typeINTERVENTIONAL
Allocationnon randomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment47
Start date15 January 2018
Primary completion21 October 2021
Estimated completion21 June 2022
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Nantes University Hospital

Who can join

Adults 18 to 70, any sex, with Graft Versus Host Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute or chronic graft versus host disease is still the major complication of stem cells transplantation regarding morbidity and mortality. Recently, high dose cyclophosphamide utilization early after post-transplantation (day+ 3 and +4) not only for patients with HLA- haploidentical donor but also for patients with Human Leukocyte Antigen (HLA)-compatible donor, showed a great control of graft versus host disease after transplantation, allowing to consider stopping immunosuppressive treatment after the transplantation (Neoral=cyclosporine, cell-cept=mycophenolate mofetil). Indeed, this step has already been completed in myeloablative transplantation in adult patients. This approach could enable to avoid in the end several complications related to long term immunosuppressive drugs administration, while promoting quicker immunity recovery.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Post-transplantation Cyclophosphamide: From HLA-Haploidentical to Matched-Related and Matched-Unrelated Donor Blood and Marrow Transplantation.
    Williams L, Cirrone F, Cole K, Abdul-Hay M, et al · · 2020 · cited 32× · PMID 32373119 · DOI 10.3389/fimmu.2020.00636
  2. Clofarabine-based reduced intensity conditioning regimen with peripheral blood stem cell graft and post-transplant cyclophosphamide in adults with myeloid malignancies.
    Chevallier P, Peterlin P, Garnier A, Le Bourgeois A, et al · · 2018 · cited 13× · PMID 30323896 · DOI 10.18632/oncotarget.26083
  3. Post-transplant cyclophosphamide as sole GHVD prophylaxis after matched reduced-intensity conditioning allotransplant.
    Bourgeois AL, Jullien M, Garnier A, Peterlin P, et al · · 2023 · cited 2× · PMID 37140099 · DOI 10.1002/ctm2.1242

Verify or expand the search:

Other trials of Fludarabine

Trials testing the same drug.

Other recruiting trials for Graft Versus Host Disease

Currently open trials in the same condition.

Other Nantes University Hospital trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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