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GVHD clinical trials

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NCT ID: NCT06083129 Not yet recruiting - GVHD Clinical Trials

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

OPTISAGE
Start date: November 1, 2023
Phase: Phase 3
Study type: Interventional

Allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains the only curative therapy in acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS). Most of the patients requiring an allo-HSCT are above 50 years of age and are transplanted with a reduced intensity conditioning (RIC) regimen. The optimal RIC and Graft Versus Host Disease (GVHD) prophylaxis regimen allowing a good control of the disease while preventing GVHD remains to be determined for elderly patients. A phase III trial comparing the conventional RIC fludarabine-busulfan 2 days to fludarabine-treosulfan demonstrated an advantage for the flu-treosulfan arm in terms of event free survival (EFS), that should therefore be considered as the new standard of RIC regimen for AML and MDS. GVHD prevention has a crucial role in post-transplant outcomes by potentially interfering with the graft-versus-leukemia (GVL) effect and immune reconstitution. Anti-thymocyte globulins (ATG) are recommended to reduce the risk of acute and chronic GVHD in transplants performed with matched unrelated donors. However, the optimal type of ATG between the 2 approved brands (ATG-thymoglobulin and ATLG-grafalon) displaying distinct characteristics and the optimal dose of ATG are still unknown. In a retrospective study of patients transplanted mainly with RIC with matched related and unrelated donors for haematological malignancies, we observed that Anti-T lymphocyte globulin (ATLG) was associated with a reduction of grade II-IV acute GVHD in comparison to ATG without increasing the incidence of relapse. In this phase III randomised study, we propose to compare GVHD prevention with ATG versus ATLG in AML and MDS patients above 50 years of age transplanted with a matched unrelated donor following a fludarabine-treosulfan RIC, with the hypothesis that ATLG would better control GVHD in this population of patients thus limiting the risk of morbidity and mortality of the procedure.

NCT ID: NCT06075225 Not yet recruiting - GVHD Clinical Trials

MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib

Start date: October 1, 2023
Phase: Phase 2
Study type: Interventional

The goal of this observation study is to test in patients undergoing allogeneic hemopoietic stem-cell transplantation (allo-HSCT). The main question it aims to answer is: • Effect of MAGIC algorithm probability guided preemption of aGVHD with ruxolitinib on prevention of severe aGVHD. Participants will take ruxolitinib with the dose of 5mg bid for 28 days. If no signs of aGvHD, the dose of ruxolitinib is gradually tapered within the following 16 days. Researchers will compare patients who don't receive preemption of aGVHD with ruxolitinib to see if there is an improvement in severe aGVHD.

NCT ID: NCT06000982 Not yet recruiting - GVHD Clinical Trials

Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis

Start date: October 1, 2023
Phase: Phase 3
Study type: Interventional

Post-transplantation cyclophosphamide (PTCY) is considered as major graft versus host disease (GVHD) prophylaxis. In our previous study, the investigators demonstrated that the standard dose PTCY of 50mg/kg with tacrolimus and post-engrafted low-dose anti-thymoglobulin (ATG) achieved low incidence of acute GVHD. More recently, it has been shown that reduced dose of PTCY of 40mg/kg is considered with similar efficacy as GVHD prophylaxis, In this study, a multi-center randomized comparison is planned to evaluate the clinical outcome of GVHD prophylaxis of PTCy 40 versus 50.

NCT ID: NCT05675930 Recruiting - Clinical trials for Graft-Versus-Host Disease

A Study of Photobiomodulation (PBM) Therapy in People With Oral Graft-Versus-Host Disease (GVHD) After Stem Cell Transplant

Start date: December 22, 2022
Phase: Phase 2
Study type: Interventional

The purpose of this study is to find out whether photobiomodulation/PBM therapy using the Thor LX2.3 therapy system is a safe and effective treatment for oral Graft-Versus-Host Disease/GVHD.

NCT ID: NCT05544448 Not yet recruiting - Clinical trials for Rheumatoid Arthritis

In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases

MuTreg
Start date: October 15, 2022
Phase: N/A
Study type: Interventional

Interleukin 2 (IL-2) is a critical cytokine for the survival and function of regulatory T cells (LTreg). This cytokine has a dual role in the immune system. IL-2 stimulates immune responses by acting on the intermediate affinity IL-2R receptor, IL-2Rβγ, expressed by conventional T cells (LTconv) during activation, but also contributes to the inhibition of immune responses via LTreg that express the high affinity receptor IL-2Rαβγ. This difference in IL-2 receptor affinity for IL-2 has led to the development of low-dose IL-2 therapy to stimulate LTreg and improve control of excessive inflammation in autoimmune (AID), inflammatory or alloimmune diseases Low-dose IL-2 therapy is being studied in several of these diseases such as systemic lupus erythematosus, type 1 diabetes, alopecia, HCV (hepatitis C virus)-induced vasculitis, atopic dermatitis and chronic allo-transplantation-related graft-versus-host disease (GVHD). Some of these studies have shown an increase in LTreg numbers and an improvement in certain clinical signs. To improve LTreg targeting in autoimmune diseases, inflammatory diseases or GVHD, mutated IL-2s (muteins) have been developed with selective LTreg agonist properties. These IL-2 muteins are linked to an Fc fragment to increase their half-life. Two IL-2 variants (IL-2Vs)-Fc preferentially stimulate STAT5 phosphorylation in LTregs compared to conventional FoxP3- (LTconv) CD4+ or CD8+ T cells

NCT ID: NCT05415410 Active, not recruiting - GVHD Clinical Trials

Proof-of-concept Trial of Apraglutide in GVHD

Start date: May 25, 2022
Phase: Phase 2
Study type: Interventional

The aim of this trial is to assess safety and efficacy of apraglutide in subjects with steroid refractory gastrointestinal acute graft versus host disease (aGVHD).

NCT ID: NCT05263999 Recruiting - Clinical trials for Graft Versus Host Disease

A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR)

Start date: April 29, 2022
Phase: Phase 3
Study type: Interventional

This is a multi-center study to compare the efficacy and safety of itolizumab versus placebo as first-line therapy for subjects with Grade III-IV aGVHD or Grade II with LGI involvement, in combination with corticosteroids

NCT ID: NCT05094765 Not yet recruiting - GVHD Clinical Trials

Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD

Start date: November 1, 2021
Phase: Early Phase 1
Study type: Interventional

This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs. host disease after allogeneic stem cell transplantation

NCT ID: NCT04945096 Not yet recruiting - Relapse Clinical Trials

Outcomes of Patients After Allo-HSCT With Decitabine and NAC

Start date: July 1, 2021
Phase: Phase 3
Study type: Interventional

The investigators will conduct this prospective and randomized clinical trial, to evaluate the hematopoietic reconstitution, GVHD and relapse rate of patients after allo-HSCT with decitabine containing conditional regimen and NAC treatment.

NCT ID: NCT04473911 Active, not recruiting - Clinical trials for Acute Myeloid Leukemia

Haplo Peripheral Blood Sct In GVHD Prevention

Start date: August 14, 2020
Phase: Phase 1
Study type: Interventional

This research study is studying the RGI-2001 for preventing Graft-vs-Host Disease (GVHD) in people with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPN), chronic myelomonocytic leukemic (CMML), chemosensitive hodgkin lymphoma (HL), or Non-Hodgkin lymphoma (NHL).who will have a blood stem cell transplantation. - GVHD is a condition in which cells from the donor's tissue attack the organs. - RGI-2001 is an investigational treatment