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Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT | Clinical Trials | Clareo Health

TERMINATEDPHASE1/PHASE2

Ibrutinib Plus Rituximab for cGVHD Following Allo-SCT

Combination Ibrutinib and Rituximab for the Treatment of Chronic Graft-Versus-Host Disease Following Allogeneic Stem Cell Transplant

NCT03689894•Dartmouth-Hitchcock Medical Center

View on ClinicalTrials.gov

Summary

Allogeneic stem cell transplant is used to treat a variety of blood cancers. However, graft-versus-host disease (GVHD) is a common condition that may occur after transplant. GVHD happens when the donor cells attack and damage the recipients' tissue. The standard medication to treat chronic graft-versus-host-disease (cGVHD) is corticosteroids. However, there are long-term side effects of steroid therapy, including risk of infection, bone loss and other health problems. In addition, some patients with cGVHD do not respond to standard steroid therapy. In these cases, medications to suppress the immune system may be used. The purpose of this study is to learn about the effects, both good and bad, of combining the drugs ibrutinib and rituximab for the treatment of cGVHD. Ibrutinib is Food and Drug Administration (FDA)-approved for the treatment of cGVHD which has not responded to steroid therapy. Rituximab is an investigational drug, which means it is not FDA approved for this particular use. Rituximab is currently approved for treatment of Non-Hodgkin's Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), and other conditions, but is not FDA approved for the treatment of cGVHD. However, rituximab has been used in a clinic setting for the treatment of cGVHD in a number of patients over the past few years, and has generally been well tolerated and shown some benefit. The combination of ibrutinib and rituximab is being studied in the treatment of certain types of lymphoma and chronic leukemia, but it has not yet been combined for patients with cGVHD. Because ibrutinib is not approved for this use when combined with rituximab, it is considered investigational in this study. In this form, the term "study drug" refers to ibrutinib and rituximab. This study will involve people who have chronic GVHD, have previously taken corticosteroids, and have either not benefited from treatment with corticosteroids or have been unable to successfully taper off steroids.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Men and women ≥18 years old who are recipients of an allogeneic bone marrow, cord blood or peripheral blood stem cell transplant. (There will be no restrictions based upon underlying disease, donor source, degree of human leukocyte antigen (HLA) match, intensity of pre-transplant conditioning regimen or use of prior donor lymphocyte infusion(s).)
•2. Chronic GVHD that is confirmed by clinical assessment and/or biopsy.
•3. Either steroid-refractory or steroid-dependent cGVHD.
•4. Karnofsky performance status ≥ 60.

Exclusion Criteria

•1. History of treatment with a tyrosine kinase inhibitor (eg, imatinib) or other moderate-to-significant Cyclophilin A4 inhibitor within 2 weeks of enrollment.
•2. Renal insufficiency as follows: creatinine \> 2.5 mg/deciliters (dL) or Creatinine Clearance \< 30 ml/min.
•3. Hepatic insufficiency as follows: serum bilirubin \>3 mg/dL or transaminitis \>3x upper limit of normal (ULN) (unless deemed due to GVHD).
•4. History of cardiac dysrhythmias or known cardiovascular disease without formal Cardiology clearance.
•5. History of cerebro-vascular accident or intracranial hemorrhage within 6 months prior to enrollment.
•6. History of non-intracranial hemorrhage and/or coagulopathy without formal Coagulation clearance.
•7. Uncontrolled infections not responsive to antibiotics, anti-viral medicines, or anti-fungal medicines; or infection requiring systemic treatment that was completed ≤14 days before enrollment.
•8. History of other hematologic malignancy.
•9. History of human immunodeficiency virus (HIV).
•10. History of active hepatitis B virus (HBV) or hepatitis C virus (HCV) without formal Infectious Disease clearance.
+2 more criteria

Locations (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Key Dates

Start Date

April 11, 2019

Primary Completion Date

September 20, 2021

Completion Date

September 20, 2021

Last Updated

November 28, 2023

Enrollment

ACTUAL participants

Conditions

Chronic Graft-versus-host-disease

Interventions

Ibrutinib

DRUG

Rituximab

DRUG

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TERMINATEDPHASE2

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COMPLETEDPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 28, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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