Chronic Graft Versus Host DiseasePhase 2NCT06046248
Belumosudil and Rituximab for Primary Treatment of Chronic Graft-Versus-Host-Disease
A Phase 2 study testing Belumosudil and Rituximab in people with Chronic Graft Versus Host Disease, run by Northside Hospital, Inc. at 1 site in United States.
Trial summary
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Graft Versus Host Disease
- What is being tested?
- Belumosudil and Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2024to 31 Dec 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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#
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-host Disease
This is an open-label, Phase 2 study designed to evaluate the safety and efficacy of belumosudil and rituximab as primary treatment of cGVHD.
- Conditions
- Chronic Graft Versus Host Disease
- Being tested
- Belumosudil, Rituximab
- Medical subject headings
- Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BelumosudilDrug
200mg PO QD x 24 cycles (28-day cycle)
RituximabDrug
375mg/m2 IV Q1 week x 4 weeks, then Q3 months x4 doses
| Study group | Role | What they receive |
|---|---|---|
| Belumosudil Plus Rituximab | Experimental | Belumosudil plus Rituximab Receives: Drug: Belumosudil; Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who achieve partial and complete responses after treatment
Measured: 2 years
Secondary outcomes (2)
Length of time patients remain on corticosteroid treatment
Measured: 2 years
Number of patients who had treatment-related adverse events using CTCAE v5
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start29 Jan 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Why it stopped: Lack of funding and slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Chronic Graft Versus Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northside Hospital, Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi
- Responsible party
- Sponsor
- Investigators
- Scott Solomon, MD, Principal investigator, BMTGA/Northside Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06046248
- Sponsor's protocol ID
- NSH 1385
- Status last verified
- Oct 2026
- First submitted
- 14 Sep 2023
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 19597425Bhatia 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-2007-03-082933. Epub 2007 Aug 1.
PubMed 17671231Schmitz 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 Transplantation. Blood. 2006 Dec 15;108(13):4288-90. doi: 10.1182/blood-2006-05-024042. Epub 2006 Aug 31.
PubMed 16946302Higman 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.
PubMed 15142114Koc 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.
PubMed 12070007Vogelsang GB. How I treat chronic graft-versus-host disease. Blood. 2001 Mar 1;97(5):1196-201. doi: 10.1182/blood.v97.5.1196.
PubMed 11222360Ratanatharathorn 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.
PubMed 11509929Sutherland 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.
PubMed 9193757Chiodi S, Spinelli S, Ravera G, Petti AR, Van Lint MT, Lamparelli T, Gualandi F, Occhini D, Mordini N, Berisso G, Bregante S, Frassoni F, Bacigalupo A. Quality of life in 244 recipients of allogeneic bone marrow transplantation. Br J Haematol. 2000 Sep;110(3):614-9. doi: 10.1046/j.1365-2141.2000.02053.x.
PubMed 10997973Fraser CJ, Bhatia S, Ness K, Carter A, Francisco L, Arora M, Parker P, Forman S, Weisdorf D, Gurney JG, Baker KS. Impact of chronic graft-versus-host disease on the health status of hematopoietic cell transplantation survivors: a report from the Bone Marrow Transplant Survivor Study. Blood. 2006 Oct 15;108(8):2867-73. doi: 10.1182/blood-2006-02-003954. Epub 2006 Jun 20.
PubMed 16788100Kiss TL, Abdolell M, Jamal N, Minden MD, Lipton JH, Messner HA. Long-term medical outcomes and quality-of-life assessment of patients with chronic myeloid leukemia followed at least 10 years after allogeneic bone marrow transplantation. J Clin Oncol. 2002 May 1;20(9):2334-43. doi: 10.1200/JCO.2002.06.077.
PubMed 11981005Stewart BL, Storer B, Storek J, Deeg HJ, Storb R, Hansen JA, Appelbaum FR, Carpenter PA, Sanders JE, Kiem HP, Nash RA, Petersdorf EW, Moravec C, Morton AJ, Anasetti C, Flowers ME, Martin PJ. Duration of immunosuppressive treatment for chronic graft-versus-host disease. Blood. 2004 Dec 1;104(12):3501-6. doi: 10.1182/blood-2004-01-0200. Epub 2004 Aug 3.
PubMed 15292060Duell T, van Lint MT, Ljungman P, Tichelli A, Socie G, Apperley JF, Weiss M, Cohen A, Nekolla E, Kolb HJ. Health and functional status of long-term survivors of bone marrow transplantation. EBMT Working Party on Late Effects and EULEP Study Group on Late Effects. European Group for Blood and Marrow Transplantation. Ann Intern Med. 1997 Feb 1;126(3):184-92. doi: 10.7326/0003-4819-126-3-199702010-00002.
PubMed 9027268Socie G, Stone JV, Wingard JR, Weisdorf D, Henslee-Downey PJ, Bredeson C, Cahn JY, Passweg JR, Rowlings PA, Schouten HC, Kolb HJ, Klein JP. Long-term survival and late deaths after allogeneic bone marrow transplantation. Late Effects Working Committee of the International Bone Marrow Transplant Registry. N Engl J Med. 1999 Jul 1;341(1):14-21. doi: 10.1056/NEJM199907013410103.
PubMed 10387937Sullivan KM, Witherspoon RP, Storb R, Weiden P, Flournoy N, Dahlberg S, Deeg HJ, Sanders JE, Doney KC, Appelbaum FR, et al. Prednisone and azathioprine compared with prednisone and placebo for treatment of chronic graft-v-host disease: prognostic influence of prolonged thrombocytopenia after allogeneic marrow transplantation. Blood. 1988 Aug;72(2):546-54.
PubMed 3042041