scholarly journals Treatment of chronic GvHD with mesenchymal stromal cells induces durable responses: A phase II study

2020 ◽  
Vol 9 (10) ◽  
pp. 1190-1202 ◽  
Author(s):  
Erik Boberg ◽  
Lena Bahr ◽  
Gabriel Afram ◽  
Carina Lindström ◽  
Per Ljungman ◽  
...  
Keyword(s):  
Phase Ii ◽  
Mesenchymal Stromal Cells ◽  
Stromal Cells ◽  
Phase Ii Study ◽  
Chronic Gvhd

scholarly journals Multipotent Mesenchymal Stromal Cells for the Prophylaxis of Acute Graft-versus-Host Disease—A Phase II Study

2012 ◽  
Vol 2012 ◽  
pp. 1-8 ◽  
Author(s):  
Larisa A. Kuzmina ◽  
Natalia A. Petinati ◽  
Elena N. Parovichnikova ◽  
Lidia S. Lubimova ◽  
Elena O. Gribanova ◽  
...  
Keyword(s):  
Phase Ii ◽  
Mesenchymal Stromal Cells ◽  
Graft Versus Host Disease ◽  
Stromal Cells ◽  
Phase Ii Study ◽  
Multipotent Mesenchymal Stromal Cells ◽  
Host Disease ◽  
Graft Versus Host ◽  
Acute Graft

Allogeneic blood cell transplantation without posttransplant colony-stimulating factors in patients with hematopoietic neoplasm: a phase II study.

1996 ◽  
Vol 14 (4) ◽  
pp. 1314-1319 ◽  
Author(s):  
C Rosenfeld ◽  
R Collins ◽  
L Piñeiro ◽  
E Agura ◽  
J Nemunaitis
Keyword(s):  
Stem Cells ◽  
Bone Marrow ◽  
Blood Cell ◽  
Cell Transplantation ◽  
Phase Ii ◽  
Phase Ii Study ◽  
Chronic Gvhd ◽  
Allogeneic Blood ◽  
Platelet Recovery ◽  
Colony Stimulating Factors

PURPOSE There is limited experience with allogeneic blood cell transplantation (BCT). In an earlier pilot study, the combination of bone marrow and blood did not produce severe acute graft-versus-host disease (GVHD). We now report the results of a phase II study using blood stem cells alone in 19 patients. PATIENTS AND METHODS The median age was 40 years. All patients had hematopoietic malignancies and received transplants from HLA-identical sibling donors. GVHD prophylaxis consisted of cyclosporine plus prednisone. Posttransplant colony-stimulating factors were not administered. Donors were mobilized with subcutaneous granulocyte colony-stimulating factor (G-CSF; 16 microg/kg/d) for 5 days. Apheresis was performed on 2 consecutive days. RESULTS The median cell content of the two apheresis was 11.9 x 10(8) WBC/kg, 3.2 x 10(8) CD3/kg, and 8.3 x 10(6) CD34/kg. The median time to achieve an absolute neutrophil count (ANC) > or = 500/microL was 13 days, and 14 days to a platelet count > or = 50,000/microL. All patients engrafted. Platelet recovery was faster in marrow historic control groups. Blood cells in all tested cases contained more than 95% donor cells on day 30. The actuarial incidence of acute GVHD was 37%, and 13% for grade II-IV GVHD. Limited, corticosteroid responsive, chronic GVHD developed in 33% of assessable patients. At a median follow-up of 192 days, actuarial survival was 75%. CONCLUSION Transplantation of a high number of stem cells may lead to rapid engraftment without the use of posttransplant colony-stimulating factors. GVHD does not appear to be more severe than in similarly treated patients undergoing bone marrow transplantation. For allogeneic transplantation, mobilized blood cell collections are an alternative to bone marrow collections.

Treatment Outcome of Steroid-Refractory Chronic Graft-Versus-Host Disease with Weekly Rituximab Followed by Maintenance Rituximab: a KSBMT Multicenter Phase II Study.

Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 1151-1151
Author(s):  
Seok Jin Kim ◽  
Chang Ki Min ◽  
Jong Wook Lee ◽  
Bin Cho ◽  
Chul Won Jung ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Oral Cavity ◽  
Phase Ii ◽  
Graft Versus Host Disease ◽  
Phase Ii Study ◽  
Chronic Gvhd ◽  
Graft Versus Host ◽  
Steroid Refractory

Abstract Abstract 1151 Poster Board I-173 Introduction The mainstay of treatment for chronic graft-versus-host disease (GVHD) is steroid. However, there is limited treatment option for steroid-refractory chronic GVHD. Although the pathogenesis of chronic GVHD is still uncertain, the possible relation of auto-antibodies with chronic GVHD (Patriarca F, et al. Exp Hematol 389-96, 2006) and the result from a previous pilot study (Cutler C, et al. Blood 756-762, 2006) suggested that a treatment strategy targeting against B cells might become another effective therapy for chronic GVHD. Thus, we performed a study to determine the efficacy of rituximab (Mabthera®, Roche), an anti-CD20 monoclonal chimeric antibody in patients with steroid-refractory chronic GVHD. Patients and methods This is a multicenter, open-labeled prospective phase II study performed by the Korean Society of Blood and Marrow Transplantation (NCT00472225). Patients should be diagnosed as chronic GVHD according to the criteria for clinical trials in chronic GVHD proposed by National Institutes of Health Consensus Development Project (Filipovich AH, et al. Biol Blood Marrow Transplant 945-56, 2005). The steroid-refractoriness was defined as the same severity during the last one month while patients received the equivalent of prednisone ≥0.5mg/kg per day or 1mg/kg every other day at least for 30 days or longer. The treatment schedule consists of induction (rituximab 375mg/m2 weekly IV for 4 consecutive weeks) and maintenance (rituximab 375mg/m2 monthly IV for 4 consecutive months). The response and the quality of life (SF36 questionnaire) were evaluated during the follow-up. Results 37 patients (20 male, 17 female) were evaluated, and their median age was 29 years (range 8-57 years, 7 patients from pediatrics and 30 from internal medicine). The time interval between transplantation and rituximab treatment was from 4.0 to 45.7 months. The most commonly involved organs were skin, oral cavity, eyes and lungs. The average number of involved organ per each patient was three and their average severity was grade 2-3. The median potential follow-up was 12.3 months (95% confidence interval: 12.06-12.54 months). The maximum response during follow-up was as follows: 8 complete response (21.6%), 22 partial response (59.5%), 6 no response (16.2%), and 1 disease progression (2.7%). Thus, the overall response rate was 81.1%. The dosage of steroid was reduced in all responders including complete withdrawal of steroid. The quality of life was improved in terms of physical health and mental/emotional health after treatment. However, 5 responders showed the progression of disease activity during follow-up, and infectious complications were life-threatening, thus, 8 patients died due to infections including pneumonia. The involvement of skin and oral cavity showed better response than the involvement of lungs and eyes. Conclusion The weekly administration of rituximab followed by monthly maintenance rituximab may be an effective treatment for steroid-refractory chronic GVHD, however, the active prophylaxis against infection should be considered. Disclosures No relevant conflicts of interest to declare.

scholarly journals Mesenchymal stromal cells as treatment for chronic GVHD

2011 ◽  
Vol 46 (2) ◽  
pp. 163-164 ◽  
Author(s):  
O Ringden ◽  
A Keating
Keyword(s):  
Mesenchymal Stromal Cells ◽  
Stromal Cells ◽  
Chronic Gvhd

Post-transplant cyclophosphamide in matched and haploidentical transplant recipients receiving myeloablative timed sequential busulfan conditioning regimen: Results of a phase II study.

2019 ◽  
Vol 37 (15_suppl) ◽  
pp. 7007-7007
Author(s):  
Uday R. Popat ◽  
Rohtesh S. Mehta ◽  
Roland Bassett ◽  
Amanda Leigh Olson ◽  
Amin Majid Alousi ◽  
...  
Keyword(s):  
Phase Ii ◽  
Disease Risk ◽  
Phase Ii Study ◽  
Risk Index ◽  
Chronic Gvhd ◽  
Conditioning Regimen ◽  
Area Under The Curve ◽  
Pharmacokinetic Studies ◽  
Target Area ◽  
Post Transplant

7007 Background: Myeloablative stem cell transplants have a lower rate of relapse than reduced intensity regimens. Timed sequential busulfan (TSB) with fludarabine (Flu) is a promising myeloablative regimen for patients undergoing matched sibling (MSD) or unrelated (MUD) donor transplantation (HCT) with low non-relapse mortality (NRM) (Popat et al Lancet Haematology 2018), but was not tested in haploidentical (haplo). Also, whether this approach can be used with post-transplant cyclophosphamide (PTCy) in MSD, MUD and haplo HCT is unknown. To address these issues, we conducted a prospective phase II study. Methods: Patients with hematological malignancies with MSD, MUD or haplo donor were eligible. They received fixed doses of Busulfan(BU) 80mg/m2 either on day -13 and -12 (n=45) or on -20 and -13 (n=10). Then, Flu 40mg/m2 was given on day -6 to -2 followed by Bu dosed to achieve target area under the curve (AUC) of 20,000 umol/min for the whole course based on pharmacokinetic studies. Thiotepa 5mg/kg was given on day -7 to haplo group. GVHD prophylaxis was PTCy 50mg/kg on day 3 and 4 and tacrolimus. Haplo and later MUD recipients also received mycophenolate mofetil. Results: 55 patients with a median age of 47 (15-65) years were enrolled. 30 patients had AML or MDS, 9 CML or MPD, 5 lymphoma, 5 myeloma and 6 ALL. About half had haplo 26 (47%); others had MUD 18 (33%) or MSD 11(20%). Disease risk index was high in 18 (32%), intermediate in 32 (58%), and low in 5 (9%) patients. Comorbidity score was ≥3 in 22 (40%) patients. With a median follow up of 17 months (5-28), 1-year OS, PFS, NRM and relapse rates were 71% (60-84%), 63% (51-77%), 20% (9-31%), and 17% (7-27%), respectively [Table]. There were no graft failures. Day 100 grade II-IV and III-IV acute GVHD rates were 38% (25-51%) and 9% (95% CI 1-17%), respectively; 1-year chronic GVHD and extensive chronic GVHD rates were 10% (2-28%) and 8% (0-15%), respectively. 1-year OS in MSD, MUD and haplo groups were 91% (75-100%), 72% (54-96%), and 62% (45-83%) respectively (P=0.11). Conclusions: Myeloablative TSB with PTCy is feasible in MSD, MUD and haplo HCT. It lowers the incidence of severe acute and chronic GVHD without apparent increase in relapse. Clinical trial information: NCT02861417. [Table: see text]

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