Graft-versus-host Disease (GVHD)NCT03147742
An Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
A study testing Ruxolitinib in people with Graft-versus-host Disease (GVHD), run by Incyte Corporation at 33 sites in United States.
Trial summary
To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Graft-versus-host Disease (GVHD)
- What is being tested?
- Ruxolitinib
- Type of treatment
- Pill or oral medicine
- How many people
- Not given
- Where
- 33 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- 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 12 years and older
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Male or female, 12 years of age or older.
- Have undergone an allo-HSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible.
- Clinically suspected all grades chronic GVHD according to NIH Consensus Criteria that is refractory or intolerant to corticosteroids, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic regimen. Clinical suspicion of steroid-refractory chronic GVHD by the treating physician is also sufficient.
- Evidence of myeloid engraftment (eg, absolute neutrophil count ≥ 1.0 × 10^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed.
- Evidence of platelet engraftment (ie, platelets ≥ 20 × 10^9/L).
- Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3.
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- Be willing to avoid pregnancy or fathering children based on 1 of the following criteria:
- Women of non-childbearing potential (ie, surgically sterile with a hysterectomy and/or bilateral oophorectomy OR ≥ 12 months of amenorrhea).
- Woman of childbearing potential who has a negative serum pregnancy test at screening and who agrees to take appropriate precautions to avoid pregnancy (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the patient and their understanding confirmed.
- Man who agrees to take appropriate precautions to avoid fathering children (with at least 99% certainty) from screening through safety follow-up. Permitted methods that are at least 99% effective in preventing pregnancy should be communicated to the patient and their understanding confirmed.
- Able to provide written informed consent and/or assent from the patient, parent, or guardian.
Who cannot join
- Eligible for an existing and actively enrolling Incyte sponsored clinical trial for ruxolitinib for the treatment of GVHD.
- Clinically suspected all grades of acute GVHD as per Minnesota-Center for International Blood and Marrow Transplant Research (MN-CIBMTR) criteria or clinical suspicion of acute GVHD by the treating physician.
- Patients or legal guardians unable to review and sign informed consent form.
- Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant.
- Patients with inadequate liver function (alanine aminotransferase above 4 × upper limit of normal (ULN) or direct bilirubin 4 × ULN and the laboratory abnormalities are considered to be due to underlying liver dysfunction) unless attributed to GVHD.
- Patients with end stage renal function (creatinine clearance (CrCl) < 15 mL/min or glomerular filtration rate < 15 mL/min), regardless of whether hemodialysis is required.
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- Any underlying or current medical or psychiatric condition that, in the opinion of the treating physician, would place the patient at an unacceptable risk if he or she were to participate in the program.
- Previous allergic reactions to Janus kinase (JAK) inhibitors or excipients.
- Patients who are currently taking any anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, or tumor embolization).
- Concomitant use of any JAK inhibitor.
- Initiating therapy with any investigational medication.
- Presence of an active uncontrolled infection. An active uncontrolled infection is defined as hemodynamic instability attributable to sepsis or new symptoms, worsening physical signs, or radiographic findings attributable to infection. Persisting fever without signs or symptoms will not be interpreted as an active uncontrolled infection.
- Known HIV infection.
- Active hepatitis B virus (HBV) or hepatitis C virus infection that requires treatment or at risk for HBV reactivation. At risk for HBV reactivation is defined as hepatitis B surface antigen positive or anti-hepatitis B core antibody positive. Previous test results obtained as part of standard of care before allo-HSCT that confirm a patient is immune and not at risk for reactivation (ie, hepatitis B surface antigen negative, surface antibody positive) may be used for purposes of eligibility.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United States33 sites
New Mexico Cancer Center
Albuquerque, New Mexico, 87109
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-5271
Massachusetts General Hospital
Boston, Massachusetts, 02214
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Illinois Chicago
Chicago, Illinois, 60612
Cleveland Clinic
Cleveland, Ohio, 44195
Ohio State University
Columbus, Ohio, 43210
Texas Oncology
Dallas, Texas, 75246
Colorado Blood Cancer Institute
Denver, Colorado, 80218
City of Hope Medical Center
Duarte, California, 91010
Gettysburg Cancer Center
Gettysburg, Pennsylvania, 17325
Spectrum Health
Grand Rapids, Michigan, 49503
Greenville Health System Cancer Institute
Greenville, South Carolina, 29615
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Houston Methodist
Houston, Texas, 77030
Indiana Blood and Marrow Transplantation
Indianapolis, Indiana, 46237
Scripps Clinic
La Jolla, California, 92037
Nicklaus Children's Hospital
Miami, Florida, 33155
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Rutgers Cancer Institute
New Brunswick, New Jersey, 08903
Weill Cornell Medical College
New York, New York, 10021
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Blood & Marrow Transplant Center
Orlando, Florida, 32804
Mayo Clinic Arizona
Phoenix, Arizona, 85054
Allegheny Health Network Cancer Institute
Pittsburgh, Pennsylvania, 15224
Oregon Health & Science University
Portland, Oregon, 97239
Mayo Clinic Minnesota
Rochester, Minnesota, 55905
Methodist Hospital
San Antonio, Texas, 78229
Cancer Transplant Institute at HonorHealth
Scottsdale, Arizona, 85258
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109-1024
Avera Research Institute
Sioux Falls, South Dakota, 57105
Washington University School of Medicine
St Louis, Missouri, 63110
Cancer Center of Kansas
Wichita, Kansas, 67214
About this study
Official title: An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
- Conditions
- Graft-versus-host Disease (GVHD)
- Being tested
- Ruxolitinib
- Keywords
- ruxolitinib, acute or chronic steroid-refractory GVHD, hematopoietic stem cell transplantation (allo-HSCT)
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RuxolitinibDrug
Also called INCB018424
Ruxolitinib starting dose level 10 mg orally, twice daily (BID).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graft-versus-host Disease (GVHD)Studies of the same condition, open and under way.
- More trials run by Incyte CorporationThe sponsor's other registered studies.
- 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
- Expanded access
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John Galvin, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03147742
- Sponsor's protocol ID
- INCB 18424-MA-GD-301
- Status last verified
- Jun 2022
- First submitted
- 8 May 2017
- Last updated
- 7 Jun 2022
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Expanded Access Program of Ruxolitinib for the Treatment of Graft-Versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplant
- ClinicalTrials.gov ID
- NCT03147742
- Acronym / sponsor ID
- INCB 18424-MA-GD-301
- Conditions
- Graft-versus-host Disease (GVHD)
- Keywords
- ruxolitinib, acute or chronic steroid-refractory GVHD, hematopoietic stem cell transplantation (allo-HSCT)
- Study type
- Expanded access
- Recruitment status
- Approved For Marketing
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- First posted
- 10 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To provide ruxolitinib through an expanded access program for the treatment of graft-versus-host disease (GVHD) in United States to patients who are ineligible or unable to participate in any actively enrolling Incyte-sponsored clinical studies for ruxolitinib in the treatment of GVHD.
Study design
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Male or female, 12 years of age or older.
- Have undergone an allo-HSCT from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies. Recipients of nonmyeloablative and myeloablative conditioning regimens are eligible.
- Clinically suspected all grades chronic GVHD according to NIH Consensus Criteria that is refractory or intolerant to corticosteroids, occurring after allo-HSCT with any conditioning regimen and any anti-GVHD prophylactic regimen. Clinical suspicion of steroid-refractory chronic GVHD by the treating physician is also sufficient.
- Evidence of myeloid engraftment (eg, absolute neutrophil count ≥ 1.0 × 10^9/L for 3 consecutive days if ablative therapy was previously used). Use of growth factor supplementation is allowed.
- Evidence of platelet engraftment (ie, platelets ≥ 20 × 10^9/L).
Key exclusion criteria (14 listed)
- Eligible for an existing and actively enrolling Incyte sponsored clinical trial for ruxolitinib for the treatment of GVHD.
- Clinically suspected all grades of acute GVHD as per Minnesota-Center for International Blood and Marrow Transplant Research (MN-CIBMTR) criteria or clinical suspicion of acute GVHD by the treating physician.
- Patients or legal guardians unable to review and sign informed consent form.
- Females who are pregnant or breastfeeding, and males and females who cannot comply with requirements to avoid fathering a child or becoming pregnant.
- Patients with inadequate liver function (alanine aminotransferase above 4 × upper limit of normal (ULN) or direct bilirubin 4 × ULN and the laboratory abnormalities are considered to be due to underlying liver dysfunction) unless attributed to GVHD.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RuxolitinibAlso: INCB018424Ruxolitinib starting dose level 10 mg orally, twice daily (BID). | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Galvin, MD study director
Incyte Corporation
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ruxolitinib in people with Graft-versus-host Disease (GVHD), run by Incyte Corporation at 33 sites 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 11 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 7 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites 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.
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.
Where can I read the original study information?
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 7 Jun 2022.