AzTrials
AzTrials

Chronic Graft Versus Host DiseasePhase 2NCT06271616

Ibrutinib for the Prevention of Chronic Graft-Versus-Host Disease in Patients Undergoing Donor Stem Cell Transplant

A Phase 2 study testing Echocardiography Test and Ibrutinib in people with Chronic Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by Mayo Clinic at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Echocardiography Test and Ibrutinib
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteUnited States
Study dates
13 Dec 2024to 14 May 2026
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

  • 50 to 110 days post-transplant prior to registration
  • Age ≥ 18 years
  • HLA matched-related, matched unrelated donors (defined as 8/8 [class I: HLA A, B, C, and class II: DRB1]), or HLA-mismatched-unrelated donors (defined as 7/8 [with single mismatch at class I: HLA A, B, C, or class II: DRB1])
  • Karnofsky performance status (PS) ≥ 70
  • Hemoglobin ≥ 8.0 g/dL (untransfused) (obtained ≤ 7 days prior to registration)
  • Absolute neutrophil count (ANC) ≥ 1000/mm^3 (without growth factor support) (obtained ≤ 7 days prior to registration)
Show all 18Show fewer
  • Platelet count ≥ 50,000/mm^3 (untransfused) (obtained ≤ 7 days prior to registration)
  • Prothrombin time (PT)/international normalized ratio (INR)/activated partial thromboplastin time (aPTT) ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 7 days prior to registration)
  • Total bilirubin ≤ 1.5 x ULN (unless it is due to Gilbert's syndrome or causes other than liver) OR alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 2 x ULN (unless it is due to Gilbert's syndrome or causes other than liver) (obtained ≤ 7 days prior to registration)
  • Calculated creatinine clearance ≥ 40 ml/min using the Cockcroft-Gault formula (obtained ≤ 7 days prior to registration)
  • Adequate cardiac and pulmonary function at baseline (may be based on pre-transplant vital organ work up):
  • Cardiac evaluation to determine left ventricular ejection fraction (LV-EF) if there is any clinical reason (for example an ischemic event or hypovolemic shock) to suspect that the LV-EF was affected from the time of the prior measurement of baseline (required ≥ 45%)
  • Pulmonary evaluation to determine adequate pulmonary function with a diffusion capacity of the lung for carbon monoxide (DLCO) ≥ 50% predicted value, forced expiratory volume in 1 second (FEV1) ≥ 50% predicted value and forced vital capacity (FVC) ≥ 50% predicted value
  • Persons of childbearing potential must have negative serum pregnancy test ≤ 7 days prior to registration. Persons of non-reproductive potential are defined as follows: post-menopausal by history - no menses for ≥ 1 year; or status post (s/p) hysterectomy; or s/p bilateral tubal ligation; or history of bilateral oophorectomy
  • All subjects agreeable to using both a highly effective method of birth control [for example, implants, injectables, combined oral contraceptives, intrauterine devices (IUDs), or sterilized partner] and a barrier method (e.g., condoms, vaginal ring, sponge, etc.) during the period of therapy and for 90 days after the last dose of study drug
  • Provide written informed consent
  • Willingness to return to enrolling institution for follow-up (during the active monitoring phase of the study).
  • Note: During the active monitoring phase of a study (i.e., active treatment and clinical follow-up), participants must be willing to return to the consenting institution for follow-up

Who cannot join

  • Uncontrolled acute GVHD at time of registration.
  • Note: Uncontrolled is defined as unable to tolerate tapering down of steroids or other therapies or requiring additional therapies or increase in doses of prescribed therapies
  • Evidence of NIH chronic GVHD preceding registration or at time of registration
  • Relapsed/progressive disease compared to prior to transplant and prior to registration. In this case, baseline represents the baseline disease staging (if no other disease staging has been performed prior to enrollment); or a post-transplant disease staging if that represents the most immediate staging prior to enrollment. In the event that both had been performed, the latest one performed (i.e. the one closest in time to the enrollment to this trial) will be considered the baseline for comparison.
  • Note: Relapse and progression definitions for each hematologic malignancy/ disorder will follow standard definition
  • Uncontrolled active systemic fungal, viral, bacterial, or other infection Note: Infections are considered controlled if appropriate therapy has been instituted and at the time of registration have no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection
Show all 31Show fewer
  • Unable to swallow capsules or impairment/disease significantly affecting gastrointestinal function that may significantly alter the absorption of the drugs (e.g., gastric bypass surgeries, Celiac or Whipple disease)
  • Any of the following because this study involves) an agent that has known genotoxic, mutagenic and teratogenic effects:
  • Pregnant persons
  • Nursing persons
  • Persons of childbearing potential who are unwilling to employ adequate contraception
  • History of stroke or intracranial hemorrhage ≤ 6 months prior to registration
  • Active involvement of the central nervous system with malignancy.
  • Note: Previous central nervous system (CNS) involvement is allowed if clearance of CNS disease has been documented prior to registration
  • Require anticoagulation with warfarin or other Vitamin K antagonists
  • Any of the following prior therapies:
  • Administration of anti-thymocyte globulin (or equivalent), alemtuzumab, or post transplant cyclophosphamide as part of the conditioning regimen or ≤ 1 month of allograft. Patients must not have received T-cell depletion or CD-34 selection
  • Administration of a strong cytochrome P450 (CYP) 3A inhibitor ≤ 7 days prior to the first dose or subjects who require continuous treatment with a strong CYP3A inhibitor
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  • Patients known to have tested positive on HIV antibody test
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Chronic liver disease with hepatic impairment Child Pugh class B or C
  • Active hepatitis B or C infection.
  • Note: A detailed assessment of hepatitis B/C medical history and risk factors must be done at screening for all patients. hepatitis B immunoglobulin M antibody (HBcIgM Ab), hepatitis B surface antigen (HBsAg) and hepatitis C virus antibody (HCV Ab) screen (scrn) w/reflex testing are required at screening for all patients with a positive medical history based on risk factors and/or confirmation of prior hepatitis B virus (HBV) infection
  • Receiving any chemotherapy, anticancer immunotherapy, experimental therapy, or radiotherapy is prohibited while the subject is receiving study treatment with ibrutinib. The sponsor-investigator must be notified in advance (or as soon as possible thereafter) of any instances in which prohibited therapies are administered.
  • EXCEPTION 1: Patients will be allowed to receive antimicrobial prophylaxis appropriate for allogeneic HCT recipients, according to institutional standards of practice (SOP) or common clinical practice
  • EXCEPTION 2: Patients will be allowed to receive maintenance therapy, if it had been planned prior to the allogeneic HCT for the purpose of reducing risk of relapse or progression of malignancy. Examples of post-transplant maintenance includes inhibitors of fms-like tyrosine kinase 3 (FLT-3), Isocitrate Dehydrogenase 1 (IDH-1), Isocitrate Dehydrogenase 12 (IDH-2) or hypomethylating agents (azacitidine or decitabine) and inhibitors of BCL-2.
  • Other active malignancy ≤ 5 years prior to registration.
  • EXCEPTIONS: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
  • NOTE: If there is a history of prior malignancy, they must not be receiving other treatment for their cancer
  • History of myocardial infarction ≤ 6 months, or uncontrolled cardiac arrhythmias

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224-9980

Other trials in United States

About this study

Official title: A Phase II Study of Ibrutinib as Prophylaxis for Chronic Graft-Versus-Host Disease (GVHD) in Patients Undergoing Allogeneic Hematopoietic Cell Transplantation (Allo-HCT)

This phase II trial tests how well ibrutinib works in preventing chronic graft-versus-host disease (GVHD) in patients undergoing donor (allogeneic) hematopoietic cell transplantation (HCT). An allogeneic hematopoietic cell transplantation (allo-HCT) is a treatment in which a person receives blood-forming stem cells (cells from which all blood cells develop) from a genetically similar, but not identical donor. When healthy stem cells from a donor are infused into a patient, they may help the patient's bone marrow make more healthy cells and platelets. However, sometimes the transplanted cells from a donor can attack the body's normal cells (called GVHD). Giving ibrutinib after the transplant may stop that from happening. Ibrutinib is in a class of medications called kinase inhibitors. It works by blocking a protein in the blood called Bruton's tyrosine kinase (BTK). By blocking BTK, ibrutinib inhibits certain immune cells that play a role in cGVHD. Giving ibrutinib after an allo-HCT may prevent the development of chronic GVHD.

Read the detailed description

PRIMARY OBJECTIVE:

  1. To evaluate the efficacy of ibrutinib in reducing the incidence of National Institutes of Health (NIH) moderate/severe chronic GVHD by 1-year post-registration. (Phase II Trial)

SECONDARY OBJECTIVES:

  1. To determine the safety of ibrutinib when prescribed as prophylaxis for chronic GVHD.

II. To determine the cumulative incidence of non-relapse mortality (NRM). III. To determine the cumulative incidence of relapse (CIR). IV. To determine the cumulative incidence of chronic GVHD (moderate/severe and all grades).

  1. To determine the cumulative incidence of late acute GVHD (LA GVHD). VI. To determine 1-year overall survival (OS) from time of transplantation. VII. To determine NIH moderate/severe chronic GVHD and relapse free survival (CRFS).

VIII. To determine immune suppressive therapy required for therapy of chronic GVHD.

IX. To determine the cumulative incidence of complete immune suppression (IS) discontinuation.

OUTLINE:

Patients receive ibrutinib orally (PO) once daily (QD) on days 1-30 of each cycle. Cycles repeat every 30 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo an echocardiography prior to registration on study.

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.

  • Echocardiography TestProcedure or surgery

    Also called EC, Echocardiography

    Undergo echocardiography

  • IbrutinibDrug

    Also called BTK Inhibitor PCI-32765, CRA-032765, Imbruvica, PCI-32765

    Given PO

Study groups in NCT06271616
Study groupRoleWhat they receive
Prevention (ibrutinib)ExperimentalPatients receive ibrutinib PO QD on days 1-30 of each cycle. Cycles repeat every 30 days for up to 12 cycles in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo an echocardiography prior to registration on study.
Receives: Procedure: Echocardiography Test; Drug: Ibrutinib

What is being measured

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

  1. Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD)

    The cumulative incidence of National Institutes of Health (NIH) moderate/severe chronic GVHD will be estimated from the date of registration using a competing risk model, with death and relapse without NIH moderate/severe chronic GVHD as the competing risks.

    Measured: At 1 year post registration

Secondary outcomes (11)

  1. Cumulative incidence of non-relapse mortality (NRM)

    The cumulative incidence of NRM will be estimated from the date of registration using the competing risk model, with relapse as a competing risk event.

    Measured: Up to 1 year after last dose of study drug

  2. Cumulative incidence of relapse

    The cumulative incidence of relapse will be estimated from date of registration until date of relapse using the competing risk model with NRM as a competing risk event.

    Measured: Up to 1 year after last dose of study drug

  3. Cumulative incidence of moderate/severe chronic GVHD

    The cumulative incidence of moderate/severe chronic GVHD will be estimated from date of registration until date of first evidence of moderate/severe chronic GVHD using competing risk model, with relapse and death as competing risk events.

    Measured: Up to 1 year after last dose of study drug

  4. Cumulative incidence of moderate/severe chronic GVHD

    The cumulative incidence of moderate/severe chronic GVHD assessed from transplant up to 1 year post-transplant will be estimated.

    Measured: Up to 1 year after last dose of study drug

  5. Cumulative incidence of chronic GVHD of all grades

    The cumulative incidence of all grades of chronic GVHD will be estimated using the competing risk model, with relapse and death as competing risk events.

    Measured: Up to 1 year after last dose of study drug

  6. Cumulative incidence of late acute GVHD

    The cumulative incidence of acute GVHD will be estimated using the competing risk model, with relapse and death as competing risk events.

    Measured: Up to 1 year after last dose of study drug

  7. Overall survival (OS)

    OS is defined as the time from treatment to death, regardless of disease recurrence.

    Measured: Up to 1 year after last dose of study drug

  8. NIH moderate/severe GVHD and relapse free survival (CRFS)

    NIH moderate/severe CRFS is defined as the time from registration until moderate/severe chronic GVHD, relapse, or death due to any cause.

    Measured: Up to 1 year after last dose of study drug

  9. Type and duration of immune suppressive therapy

    The type and duration of immune suppressive therapy required for therapy of chronic GVHD will be summarized and described descriptively.

    Measured: Up to 1 year after last dose of study drug

  10. Cumulative incidence of complete immune suppression (IS) discontinuation

    The cumulative incidence of complete IS discontinuation will be estimated from the date of registration until the date of discontinuation of IS.

    Measured: Up to 1 year after last dose of study drug

  11. Incidence of adverse events (AE)

    The maximum grade for each type of AE will be recorded for each patient, and frequency tables will be reviewed to determine patterns.

    Measured: Up to 1 year after last dose of study drug

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Feb 2024
  2. Study start13 Dec 2024
  3. Primary completion14 May 2026
  4. Study completion14 May 2026

Why it stopped: poor 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
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06271616
Sponsor's protocol ID
MC1873
Other IDs
NCI-2024-01061, 18-008754
Status last verified
May 2026
First submitted
14 Feb 2024
Last updated
22 May 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Echocardiography Test and Ibrutinib in people with Chronic Graft Versus Host Disease and Hematopoietic and Lymphatic System Neoplasm, run by Mayo Clinic 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 18 inclusion and 31 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: stopped early, as of the sponsor's last update on 22 May 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?

The study was stopped early (reason given: poor accrual). 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?

Cumulative incidence of NIH moderate/severe chronic graft-versus-host disease (GVHD) (time frame: At 1 year post registration). 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 NCT06271616.

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 22 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in