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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.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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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
Are there results?
None posted in the registry

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.

United States1 site

  • Northside Hospital

    Atlanta, Georgia, 30342

Other trials in United States

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.

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 groups in NCT06046248
Study groupRoleWhat they receive
Belumosudil Plus RituximabExperimentalBelumosudil plus Rituximab
Receives: Drug: Belumosudil; Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of patients who achieve partial and complete responses after treatment

    Measured: 2 years

Secondary outcomes (2)

  1. Length of time patients remain on corticosteroid treatment

    Measured: 2 years

  2. 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.

  1. First posted21 Sep 2023
  2. Study start29 Jan 2024
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Why it stopped: Lack of funding and slow accrual

Resources

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)
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 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-2007-03-082933. Epub 2007 Aug 1.

    PubMed 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 Transplantation. Blood. 2006 Dec 15;108(13):4288-90. doi: 10.1182/blood-2006-05-024042. Epub 2006 Aug 31.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 9193757

  • Chiodi 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 10997973

  • Fraser 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 16788100

  • Kiss 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 11981005

  • Stewart 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 15292060

  • Duell 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 9027268

  • Socie 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 10387937

  • Sullivan 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

Questions about this trial

What is this clinical trial studying?

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.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of patients who achieve partial and complete responses after treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06046248, which also lists 39 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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