Ibrutinib and Rituxan for Chronic GVHD
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ClinicalTrials.gov Identifier: NCT04235036 |
Recruitment Status :
Recruiting
First Posted : January 21, 2020
Last Update Posted : October 20, 2022
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Condition or disease | Intervention/treatment | Phase |
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Graft Vs Host Disease | Drug: Rituximab Drug: Ibrutinib | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 35 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B Cell Depleting Therapy With Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus-Host Disease |
Actual Study Start Date : | December 16, 2019 |
Estimated Primary Completion Date : | December 31, 2023 |
Estimated Study Completion Date : | December 31, 2024 |

Arm | Intervention/treatment |
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Experimental: Rituximab + Ibrutinib
Eligible patients will be those with a first episode of symptomatic cGVHD, requiring systemic immunosuppression for control of symptoms. Following study entry, patients will be started on rituximab plus ibrutinib.
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Drug: Rituximab
Rituximab is given IV weekly x 4 weeks (to be started on study day 7 ± 3 days), then IV q3months x 4 doses (months 4, 7, 10, 13). Drug: Ibrutinib Ibrutinib is given orally every day (28-day cycles) for a total of 12 cycles. |
- The number of patients who remain off immunosuppressive therapy at 8 weeks after the initiation of treatment. [ Time Frame: 12 months following initiation of treatment ]The primary objective is to evaluate the efficacy of the combination of rituximab and ibrutinib versus the historical experience with rituximab alone in the upfront treatment of cGVHD. Patients will be followed for 12 months following the initiation of treatment to see if they remain off immunosuppressive therapy for at least 8 weeks.
- The number of patients who respond to treatment assessed by NIH Response Criteria Working Group Report. [ Time Frame: 12 months following initiation of treatment ]To estimate chronic GVHD response (CR + PR, both individual organ response and overall response, according to 2014 NIH Response Criteria Working Group Report)
- The total cumulative steroid exposure measured by total milligrams received by each patient. [ Time Frame: 12 months following initiation of treatment ]To estimate cumulative steroid exposure (total mg methylprednisolone or equivalent)
- How long it takes for patients to discontinue treatment defined as the date all systemic immunosuppressive therapy is discontinued after resolution of GVHD. [ Time Frame: 12 months following initiation of treatment ]To estimate time to discontinuation of systemic immunosuppression (defined as the date that all systemic IST has been discontinued after resolution of all reversible manifestations of cGVHD).
- How many patients are still alive without the requirement for second-line cGVHD therapy measured by overall survival at 12 months following the initiation of treatment. [ Time Frame: 12 months following initiation of treatment ]To estimate failure-free survival (defined as being alive without the requirement for second-line cGVHD therapy).
- How many patients have not relapsed measured by progression-free survival at 12 months following the initiation of treatment. [ Time Frame: 12 months following initiation of treatment ]To estimate non-relapse mortality
- How many patients have not died measured by overall survival at 12 months following the initiation of treatment. [ Time Frame: 12 months following initiation of treatment ]To estimate overall survival
- Number of patients with treatment-related adverse events grade 3 or greater as assessed by CTCAE v.4.0. [ Time Frame: 12 months following initiation of treatment ]To estimate the incidence of grade 3 or greater adverse events, possibly or probably related to either ibrutinib and/or rituximab.
- Number of patients with treatment-related adverse events total as assessed by CTCAE v.4.0. [ Time Frame: 12 months following initiation of treatment ]To evaluate the safety and tolerability of combination of rituximab and ibrutinib versus the historical experience with rituximab alone in the upfront treatment of cGVHD.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- First episode of systemic immunosuppression-requiring cGVHD, defined as classic or overlap cGVHD by the NIH consensus criteria.
- Previously untreated cGVHD, defined by having received <10 days of corticosteroids or alternative systemic immunosuppressive agent started specifically for a new diagnosis of cGVHD.
- KPS 70% or greater
Exclusion Criteria:
- Late persistent or recurrent acute GVHD
- Active uncontrolled infection
- History of HIV infection; active HBV or HCV infection
- Inability to tolerate oral medications
- Progressive or recurrent malignancy following allogeneic transplant
- Exposure to BTK inhibitor following transplant
- Received prior treatment with ECP for cGVHD

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04235036
Contact: Scott R Solomon, MD | 404-255-1930 | ssolomon@bmtga.com | |
Contact: Stacey Brown | 404-780-7965 | stacey.brown@northside.com |
United States, Georgia | |
Northside Hospital | Recruiting |
Atlanta, Georgia, United States, 30342 | |
Contact: Stacey Brown, BA 404-780-7965 stacey.brown@northside.com | |
Contact: Caitlin Guzowski, MBA, MHA 404-851-8523 caitlin.guzowski@northside.com | |
Sub-Investigator: H. Kent Holland, MD | |
Sub-Investigator: Asad Bashey, MD | |
Sub-Investigator: Lawrence E Morris, MD | |
Sub-Investigator: Scott Solomon, MD | |
Principal Investigator: Melhem Solh, MD |
Principal Investigator: | Scott R Solomon, MD | Northside Hospital |
Responsible Party: | Northside Hospital, Inc. |
ClinicalTrials.gov Identifier: | NCT04235036 |
Other Study ID Numbers: |
NSH 1219 |
First Posted: | January 21, 2020 Key Record Dates |
Last Update Posted: | October 20, 2022 |
Last Verified: | October 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
ibrutinib rituximab cGVHD chronic GVHD |
Graft vs Host Disease Immune System Diseases Rituximab Antineoplastic Agents, Immunological |
Antineoplastic Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents |