Graft vs Host Disease Clinical Trial
Official title:
The Effect of Folinic Acid Rescue Following Methotrexate (MTX) Graft-versus-host Disease (GVHD) Prophylaxis on Regimen Related Toxicity and Transplantation Outcome: a Double Blind Randomized Controlled Study
The purpose of this study is to assess the impact of folinic acid (FA) -rescue following methotrexate (MTX) graft-versus-host disease (GVHD) prophylaxis on regimen related toxicity and transplantation outcomes after allogeneic hematopoietic cell transplantation (alloHCT) in a double blind randomized controlled trial.
A regimen consisted on a combination of a calcineurin inhibitor (CNI) with a short course of
methotrexate (MTX) is the most widely used regimen for the prevention of GVHD after
allogeneic hematopoietic cell transplantation (alloHCT). While the CNI is given in an
adjusted dose, based on blood levels, MTX is given at a fixed 3 or 4 doses (15 mg/m2 on day
+1, 10 mg/m2 on days +3, +6 +/- day +11). However, its use may be associated with
considerable toxicity, including delayed engraftment, hepatotoxicity, nephrotoxicity and
particularly oral mucositis (OM). The basis for OM is integrated: conditioning regimen and
MTX prophylaxis for acute GVHD. OM has been shown to be associated with increased mortality
and morbidity (principally from infection), significant pain, dysgeusia, difficulty
speaking, difficulty receiving nutrition, hydration and oral medications, prolonged
hospitalization and increased costs of care.
Reducing and even omitting doses of MTX due to regimen related toxicities (mucositis,
hepatic and renal toxicities) is common. However, dose reduction of MTX may be associated
with increased risk of acute GVHD and early death. Several non-randomized studies have shown
that folinic acid (FA, leucovorin) administration may reduce MTX toxicity. Nevertheless, the
efficacy and safety of its administration remain controversial. Despite limited and
uncontrolled data, the European Group for Blood and Marrow Transplantation (EBMT) and the
European LeukemiaNet working group recently recommended the use of FA-rescue and proposed a
uniform policy of FA-rescue 24h after each MTX dose: 15mg every 8h after MTX administration
on day 1, and every 6h on days 3, 6 and 11. Yet, according to several surveys (including by
EBMT-ELN) only half of bone marrow transplantation (BMT) centers use to give post MTX
FA-rescue.
The aim of this study is to assess the impact of FA-rescue following MTX GVHD prophylaxis on
regimen related toxicity and transplantation outcomes after alloHCT in a double blind
randomized controlled trial.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06080490 -
Tacrolimus Blood Concentration and Transplant-related Outcomes in Pediatric HSCT Recipients
|
||
Completed |
NCT00001637 -
Immunosuppressive Preparation Followed by Blood Cell Transplant for the Treatment of Blood Cancers in Older Adults
|
Phase 2 | |
Withdrawn |
NCT04728646 -
Evaluation of Dextenza in Patients With Ocular GVHD and Effects on Ocular Surface Disease Outcomes
|
Phase 4 | |
Suspended |
NCT01972438 -
A Randomized, Controlled, Double-masked, Clinical Trial of Autologous Serum Eye Drops for Severe Ocular Chronic Graft-versus-host Disease (GVHD) in Hematopoietic Stem Cell Transplant (HSCT) Patients
|
Phase 1/Phase 2 | |
Completed |
NCT01221766 -
Impact of Adnexal Involvement of the Severity and Prognosis of Chronic Graft-versus-Host Disease
|
N/A | |
Recruiting |
NCT01764100 -
Mesenchymal Stromal Cells (MSCs) for the Treatment of Graft Versus Host Disease (GVHD)
|
Phase 1 | |
Completed |
NCT00760981 -
A Pilot Study of Imatinib Mesylate in Steroid Refractory Chronic Graft Versus Host Disease
|
Phase 1 | |
Terminated |
NCT00298324 -
Myfortic - Treatment for Extensive cGvHD
|
Phase 3 | |
Completed |
NCT00224874 -
Treatment for Acute Graft-Versus-Host Disease (BMT CTN 0302)
|
Phase 2 | |
Completed |
NCT00023530 -
Blood and Marrow Transplant Clinical Research Network
|
N/A | |
Completed |
NCT00023491 -
Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells
|
N/A | |
Recruiting |
NCT05111834 -
IRENE-G Study: Impact of Resistance Exercise and Nutritional Endorsement on GvHD Symptoms
|
N/A | |
Completed |
NCT02841995 -
A Study to Evaluate the Safety, Tolerability, and Activity of KD025 in Subjects With Chronic Graft Versus Host Disease
|
Phase 2 | |
Recruiting |
NCT06143501 -
Alterations in Intestinal Microbiota, Metabolites, and Immune Cells in Allo-HSCT
|
||
Recruiting |
NCT04622956 -
GVHD Prophylaxis With Methotrexate in Haploidentical HCT Using Posttransplant Cyclophosphamide
|
Phase 1/Phase 2 | |
Recruiting |
NCT03340155 -
Mechanisms of Action of Photo(Chemo)Therapy in Skin Diseases
|
N/A | |
Recruiting |
NCT03836690 -
Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation
|
Phase 1 | |
Not yet recruiting |
NCT06450925 -
Vitamin A Supplementation in Allogeneic Stem Cell Transplantation.
|
N/A | |
Recruiting |
NCT01042509 -
Combination of Alemtuzumab and Rituximab at Low-doses in Refractory Chronic Graft-Versus-Host Disease
|
N/A | |
Terminated |
NCT00117702 -
Prevention of the Graft-Versus-Host-Disease in Patients After Stem Cell Transplantation With Tacrolimus and Everolimus
|
Phase 2/Phase 3 |