Recruiting NCT06046248
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Belumosudil, Rituximab.
- Who it may be relevant to
- Registry conditions: Chronic Graft Versus Host Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
Overview
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
Interventions
- Drug Belumosudil
200mg PO QD x 24 cycles (28-day cycle) - Drug Rituximab
375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses
Primary outcome measures
- Number of patients who achieve partial and complete responses after treatment [Time frame: 2 years]
Secondary outcome measures (2)
- Length of time patients remain on corticosteroid treatment [Time frame: 2 years]
- Number of patients who had treatment-related adverse events using CTCAE v5 [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- First episode of systemic immunosuppression-requiring cGVHD, defined as classic cGVHD by the NIH consensus criteria (without features or characteristics of aGVHD)
- Previously untreated, defined by having received <10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD
- KPS >/= 70%
- Adequate hematologic function independent of platelet transfusion and G-CSF for at least 7 days prior to study entry: ANC >750 cells/mm3; Platelets >30,000 cells/mm#
Exclusion criteria
- Late persistent or recurrent aGVHD
- Active uncontrolled infection
- History of HIV infection
- Active HBV or HCV infection. Subjects who are positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR result before enrollment. Those who are PCR positive will be excluded.
- Calculated CrCl <30mL/min
- AST and/or ALT >5x ULN or direct bilirubin >3x ULN
- Cardiac ejection fraction <40% or history of uncontrolled cardiac arrhythmias
- Has received more than one allogeneic transplant prior to the occurrence of cGVHD
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Northside Hospital — Atlanta
Publications
- Abou-Mourad YR, Lau BC, Barnett MJ, Forrest DL, Hogge DE, Nantel SH, Nevill TJ, Shepherd JD, Smith CA, Song KW, Sutherland HJ, Toze CL, Lavoie JC. Long-term outcome after allo-SCT: close follow-up on a large cohort treated with myeloablative regimens. Bone Marrow Transplant. 2010 Feb;45(2):295-302. doi: 10.1038/bmt.2009.128. Epub 2009 Jul 13. PMID 19597425
- Bhatia S, Francisco L, Carter A, Sun CL, Baker KS, Gurney JG, McGlave PB, Nademanee A, O'Donnell M, Ramsay NK, Robison LL, Snyder D, Stein A, Forman SJ, Weisdorf DJ. Late mortality after allogeneic hematopoietic cell transplantation and functional status of long-term survivors: report from the Bone Marrow Transplant Survivor Study. Blood. 2007 Nov 15;110(10):3784-92. doi: 10.1182/blood-2007-03-082 PMID 17671231
- Schmitz N, Eapen M, Horowitz MM, Zhang MJ, Klein JP, Rizzo JD, Loberiza FR, Gratwohl A, Champlin RE; International Bone Marrow Transplant Registry; European Group for Blood and Marrow Transplantation. Long-term outcome of patients given transplants of mobilized blood or bone marrow: A report from the International Bone Marrow Transplant Registry and the European Group for Blood and Marrow Transpla PMID 16946302
- Higman MA, Vogelsang GB. Chronic graft versus host disease. Br J Haematol. 2004 May;125(4):435-54. doi: 10.1111/j.1365-2141.2004.04945.x. PMID 15142114
- Koc S, Leisenring W, Flowers ME, Anasetti C, Deeg HJ, Nash RA, Sanders JE, Witherspoon RP, Storb R, Appelbaum FR, Martin PJ. Therapy for chronic graft-versus-host disease: a randomized trial comparing cyclosporine plus prednisone versus prednisone alone. Blood. 2002 Jul 1;100(1):48-51. doi: 10.1182/blood.v100.1.48. PMID 12070007
- Vogelsang GB. How I treat chronic graft-versus-host disease. Blood. 2001 Mar 1;97(5):1196-201. doi: 10.1182/blood.v97.5.1196. PMID 11222360
- Ratanatharathorn V, Ayash L, Lazarus HM, Fu J, Uberti JP. Chronic graft-versus-host disease: clinical manifestation and therapy. Bone Marrow Transplant. 2001 Jul;28(2):121-9. doi: 10.1038/sj.bmt.1703111. PMID 11509929
- Sutherland HJ, Fyles GM, Adams G, Hao Y, Lipton JH, Minden MD, Meharchand JM, Atkins H, Tejpar I, Messner HA. Quality of life following bone marrow transplantation: a comparison of patient reports with population norms. Bone Marrow Transplant. 1997 Jun;19(11):1129-36. doi: 10.1038/sj.bmt.1700806. PMID 9193757
Identifiers
NCT: NCT06046248 · NSH 1385