Graft Vs Host Disease Clinical Trial
Official title:
Treatment of Steroid-refractory Acute and Chronic Graft-versus-host Disease With Inhibitor of Janus Kinases
NCT number | NCT02997280 |
Other study ID # | 2016-29-1 |
Secondary ID | |
Status | Completed |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | August 2016 |
Est. completion date | April 2019 |
Verified date | April 2019 |
Source | St. Petersburg State Pavlov Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Steroid-refractory acute GVHD (srGVHD) is one of the causes of mortality after allogeneic stem cell transplantation, while steroid-refractory chronic GVHD significantly increases morbidity, aggravates quality of life and may also impact survival. Currently there is no standard treatment of srGVHD. One of the most promising agents is Janus kinase (JAK) inhibitor ruxolitinib, which in the retrospective study demonstrated excellent response rate and survival of patients with either acute or chronic srGVHD. This study prospectively evaluates the efficacy of ruxolitinib in srGVHD patients.
Status | Completed |
Enrollment | 75 |
Est. completion date | April 2019 |
Est. primary completion date | December 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 1 Year to 70 Years |
Eligibility |
Inclusion Criteria: - Diagnosis of graft-versus-host disease established based on tissue biopsy - Steroid-refractory acute or chronic graft-versus-host disease according to EBMT/ELN criteria (T. Ruutu et al, 2014) - Age 1 to 70 years - Karnofsky index >30%. - Ability for oral drug intake - Life expectancy > 1 month - Signed informed consent Exclusion Criteria: - Severe organ dysfunction: AST or ALT >5 upper normal limits (excluding cases related to liver GVHD), creatinine >2 upper normal limits - Requirement for vasopressor support at the time of enrollment - Uncontrolled bacterial or fungal infection at the time of enrollment - Pregnancy - Somatic or psychiatric disorder making the patient (or legal guardian) unable to sign informed consent |
Country | Name | City | State |
---|---|---|---|
Russian Federation | First Pavlov State Medical University of St. Petersburg | Saint-Petersburg |
Lead Sponsor | Collaborator |
---|---|
St. Petersburg State Pavlov Medical University | Ministry of Health, Russian Federation |
Russian Federation,
Zeiser R, Burchert A, Lengerke C, Verbeek M, Maas-Bauer K, Metzelder SK, Spoerl S, Ditschkowski M, Ecsedi M, Sockel K, Ayuk F, Ajib S, de Fontbrune FS, Na IK, Penter L, Holtick U, Wolf D, Schuler E, Meyer E, Apostolova P, Bertz H, Marks R, Lübbert M, Wäsch R, Scheid C, Stölzel F, Ordemann R, Bug G, Kobbe G, Negrin R, Brune M, Spyridonidis A, Schmitt-Gräff A, van der Velden W, Huls G, Mielke S, Grigoleit GU, Kuball J, Flynn R, Ihorst G, Du J, Blazar BR, Arnold R, Kröger N, Passweg J, Halter J, Socié G, Beelen D, Peschel C, Neubauer A, Finke J, Duyster J, von Bubnoff N. Ruxolitinib in corticosteroid-refractory graft-versus-host disease after allogeneic stem cell transplantation: a multicenter survey. Leukemia. 2015 Oct;29(10):2062-8. doi: 10.1038/leu.2015.212. Epub 2015 Jul 31. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Overall response rate | Partial response for acute GVHD is defined as the improvement of at least one stage in the severity of aGVHD in one organ without deterioration in any other organ. A response had to last for at least 3 weeks. Partial response for chronic GVHD was defined as reduction in GVHD National Institute of Health (NIH) severity score at east for one organ without deterioration in any other organ. A complete response was defined as the absence of any symptoms related to GVHD. Overall response is defined as presence of partial or complete response | 84 days | |
Secondary | 6-month overall survival | Time from start of ruxolitinib until death or 6 months, summarized using Kaplan-Meier estimates. | 6 months | |
Secondary | Toxicity based NCI CTC grades | Toxicity parameters based on NCI CTCAE 4.03 grades: nasea, vomiting, anemia, thrombocytopenia, leukopenia, neutropenia, hepatotoxicity (liver function tests), nephrotoxicity (creatinine), neurotoxicity (attending physician assessment), hemorrhagic cystitis (attending physician assessment). | 6 months | |
Secondary | Infectious complications, including analysis of severe bacterial, fungal and viral infections incidence | 6 months | ||
Secondary | GVHD relapse incidence after complete response | Time from stopping ruxolitinib until recurrence of GVHD or 6 months, summarized using cumulative incidence estimates. | 6 months | |
Secondary | Relapse incidence of underlying hematologic malignancy | Time from starting ruxolitinib until hematologic relapse or 12 months, summarized using cumulative incidence estimates | 12 months | |
Secondary | Quality of life measured by FACT BMT ver. 4 questionnaire in adults | 6 months | ||
Secondary | Quality of life measured by PedQL Stem Cell transplant module ver.1.0 questionnaire in children | 6 months |
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 |
NCT00023491 -
Potential of Transplanted Stem Cells to Mature Into Salivary Gland and Cheek Cells
|
N/A | |
Completed |
NCT00023530 -
Blood and Marrow Transplant Clinical Research Network
|
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 |
NCT02506231 -
The Effect of Folinic Acid Rescue Following MTX GVHD Prophylaxis on Regimen Related Toxicity and Transplantation Outcome
|
Phase 2/Phase 3 | |
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 |