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Graft Versus Host Disease clinical trials

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NCT ID: NCT03395860 Recruiting - Prophylaxis Clinical Trials

Low Dose ATG Plus Low Dose PTCy as GVHD Prophylaxis in Haplo-HSCT

ATG/PTCy
Start date: May 30, 2017
Phase: Phase 2
Study type: Interventional

Low dose Rabbit Antithymocyte Globulin plus Low-dose post-transplantation cyclophosphamide as graft-versus-host disease prophylaxis in haploidentical hematopoietic stem cell transplantation for patients with hematologic malignancies

NCT ID: NCT03395340 Not yet recruiting - Clinical trials for Graft Versus Host Disease

Topical Ruxolitinib for Cutaneous Chronic Graft Versus Host Disease (cGVHD)

Start date: January 24, 2018
Phase: Phase 2
Study type: Interventional

Background: About half the people who have a hematopoietic stem cell transplant using donor cells get cGVHD. This is chronic graft versus host disease. Immune cells from the donor may see the body tissues in the person as foreign and attack, causing damage. The skin is the most commonly affected organ. Most cGVHD therapies have serious side effects. The cream ruxolitinib inhibits proteins that may play a role in cGVHD. Objective: To test the safety and effectiveness of topical ruxolitinib 1.5 percent cream in people with cGVHD of the skin. Eligibility: People ages 12 and older with epidermal skin cGVHD Design: Participants will be screened with: Medical history Physical exam Blood and urine tests Skin sample taken (biopsy) to confirm the diagnosis. At the baseline visit, participants will have: Skin disease measured with rulers, photographs, and tracing the outline of skin lesions To complete questionnaires about their symptoms Blood and urine tests Some participants will also have a skin biopsy, or total body photographs while they wear only underwear. Participants will get the ruxolitinib cream and a placebo cream to apply to 2 separate areas of disease. They will do this twice a day for 6 weeks, if they do not have serious side effects. Neither the study team nor the participant will know which area will get ruxolitinib cream and the placebo cream. Participants will write down: When they apply the creams Any side effects Any medications they take Most participants will have 4 visits during the 6 weeks they use the creams. Some will have 3 visits and a phone call to see how they are doing. All participants will get a call 4-6 weeks after they stop. Visits include physical exams, blood tests, skin disease measurements, questionnaires, and photos.

NCT ID: NCT03367962 Not yet recruiting - Clinical trials for Graft Versus Host Disease

Detection of Graft Versus Host Disease With [18F]F-AraG

Start date: December 2017
Phase: Phase 1
Study type: Interventional

This is a single-center imaging study to determine utility of in vivo imaging with [18F]F-AraG to identify sites of Graft Versus Host Disease (GVHD) in patients highly suspected of having acute GVHD who require systemic therapy, and patients at high risk for developing acute GVHD. [18F]F-AraG PET scans will be compared to biopsy results to correlate T cell accumulation which is implicated in the disease. High risk patients will be followed to verify predictive potential of [18F]F-AraG.

NCT ID: NCT03361254 Not yet recruiting - Clinical trials for Graft Versus Host Disease

Cryopreservation of White Blood Cells Before Their UVA Irradiation for Graft Versus Host Disease Treatment

cryo-ECP
Start date: March 31, 2018
Phase: N/A
Study type: Interventional

Extracorporeal photopheresis (ECP) is a worldwide recognized treatment of acute and chronic mild to moderate graft versus host disease (GVHD), in second or further line of treatment. Contrary to immunosuppressive drugs, ECP is not associated with side effects such as opportunistic infections, and is not associated with a higher frequency of relapse of the initial hematological disease. High intensity of ECP regimen (1 to 3 sessions per week, in case of chronic or acute GVHD) seems to be correlated to a higher efficacy. However, high intensity of ECP treatment is often difficult to sustain, because of frequent logistical problems to perform aphereses, such as venous access failure, infections of central line, deep blood cytopenias that require many transfusions before performing aphereses. Merlin et al. first described the feasibility of white blood cells cryopreservation before UVA irradiation, in vitro, then in vivo. We also recently reported the feasibility and efficacy of cryopreserved ECP in a series of 20 patients (adults and children), with acute and chronic GVHD, who had recurrent contraindications to aphereses, that prevented the realization of an intensive program of ECP. No adverse events occurred, and efficacy seemed to be similar to "classical" ECP (35% of complete overall response, and 40% of partial response). White blood cells (WBC) were divided after collection on Optia or Cellex apheresis machines: one was immediately treated with 8-MOP (methoxsalen) and ultraviolet A (UVA) irradiation, while the other was cryopreserved, and further (a few days later) thawed, sensitized with 8-MOP and irradiated before injection to the patient. The aim of this study is to analyze this method in a prospective way, with complete biological data collection, of apoptosis, cytokines release etc…, necessary to the full description of cryopreservation of white blood cells before their irradiation and reinjection to the patient. We will propose this technique of cryopreservation to every patient with an indication of ECP for acute or chronic GVHD in Nancy Hospital for 18 months.

NCT ID: NCT03357159 Not yet recruiting - Clinical trials for Graft Versus Host Disease

Anti T-lymphocyte Immunoglobulin With Post Transplant Cyclophosphamide to Prevent GVHD Post Allogeneic Transplantation

Start date: December 1, 2017
Phase: Phase 2
Study type: Interventional

Investigators hypothesize that combination of ATLG with PTCy in matched or mismatched unrelated hematopoietic stem cell transplantation will reduce acute and chronic GVHD incidence. Furthermore it will allow shortening of the length of post-transplantation immunosuppression with calcineurin inhibitor (CNI) administration (currently administrated in addition to ATG as GVHD prophylaxis in daily common practice)

NCT ID: NCT03339297 Not yet recruiting - Clinical trials for Graft-versus-host Disease

An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD)

Start date: January 2018
Phase: Phase 2
Study type: Interventional

This is a study comparing the defibrotide prophylaxis arm vs standard of care arm for the prevention of aGvHD.

NCT ID: NCT03297528 Recruiting - Acute Leukemia Clinical Trials

Chemotherapy and DLI for Prevention of Second Relapse in Patients With Relapsed Acute Leukemia After Allotransplant

Start date: November 1, 2017
Phase: Phase 2
Study type: Interventional

Patients with acute leukemia relapsing after allotransplant and who respond to anti-leukaemia interventions are at high-risk of a second relapse. Previous studies from investigators reported an association between a positive minimal residual disease (MRD)-test after transplant and an increased risk of subsequent relapse. Also, patients developing chronic graft-versus-host disease (GvHD) after receiving DLI (donor lymphocyte infusion)for leukemia relapse after a first allotransplant have a lower likelihood of a second relapse compared with similar patients not developing chronic GvHD. And, our previous study also reported patients with chronic GvHD after DLI was associated with a greater frequency of a negative MRD-test and lower likelihood of subsequent relapse compared with similar persons not developing chronic GvHD. Based on these data the investigators designed a randomized control study to determine whether giving additional consolidation chemotherapy and DLI might decrease likelihood of second relapse in persons without chronic GvHD or with a positive MRD-test after initial post-relapse therapy with induction chemotherapy and DLI.

NCT ID: NCT03263767 Not yet recruiting - Clinical trials for Graft Versus Host Disease

PTCY as Sole GVHD Prophylaxis for Matched Allotransplant: CYRIC

CYRIC
Start date: January 2018
Phase: Phase 2
Study type: Interventional

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 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 mofetyl). Indeed, this step has already been completed in myeloablative transplantationin 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.

NCT ID: NCT03207958 Not yet recruiting - Clinical trials for Graft Vs Host Disease

Belimumab for Prevention of Chronic Graft-versus-Host Disease Following Allogeneic Hematopoietic Cell Transplantation

Start date: February 28, 2018
Phase: Phase 1
Study type: Interventional

Given the role of B cells in the pathophysiology of chronic graft versus host disease (GvHD), the association between elevated BAFF levels post-transplant in abnormal B-cell homeostasis and chronic GvHD, and the efficacy of belimumab in the inhibition of soluble human B lymphocyte stimulator protein (BAFF) signaling, these proof-of-principle findings support the rational for use of belimumab as prophylaxis of chronic GvHD. The investigators propose a pilot and feasibility study to assess the safety and tolerability, as well as preliminary efficacy, of belimumab as prophylaxis of chronic GvHD following allogeneic hematopoietic cell transplantation (alloHCT). The investigators' central hypothesis is that belimumab will be well tolerated and have a favorable effect on incidence and severity of chronic GvHD.

NCT ID: NCT03204721 Recruiting - Clinical trials for Graft-Versus-Host Disease

Prevention of GVHD in Patients Treated With Allogeneic SCT: Possible Role of Extracorporeal Photophoresis

GVHD
Start date: June 21, 2017
Phase: N/A
Study type: Interventional

The main aim is to test the preventive use of extracorporeal photophoresis (ECP) against development of graft-versus-host disease (GVHD) in patients undergoing allogeneic stem cell transplantation for hematological malignancy.