Hematologic MalignanciesPhase 1NCT03320642
GRAVITAS-119: Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
A Phase 1 study testing Itacitinib and Calcineurin inhibitor in people with Hematologic Malignancies, run by Incyte Corporation at 17 sites in 4 countries.
Trial summary
The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Malignancies
- What is being tested?
- Itacitinib and Calcineurin inhibitor
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 17 sitesin 4 countries
- Study dates
- 27 Feb 2018to 17 Feb 2022
- Phase
- Phase 1
- 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
- Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and < 5% blasts in the bone marrow.
- Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant.
- Must be candidates for reduced-intensity conditioning regimens.
- Must be candidates for peripheral blood stem cell transplants.
- Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to 2.
- Serum creatinine ≤ 2.0 mg/dL or creatinine clearance ≥ 40 mL/min measured or calculated by Cockcroft-Gault equation.
- Be willing to avoid pregnancy or fathering children.
Who cannot join
- Has previously received an allogenic hematopoietic stem cell transplant.
- Presence of an active uncontrolled infection.
- Known HIV infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
- Prior malignancies.
- Severe organ dysfunction.
Show all 12Show fewer
- Prior treatment with a JAK inhibitor or with an investigational agent, device, or procedure within 21 days of enrollment.
- Currently breastfeeding.
- Known allergies, hypersensitivity, or intolerance to any of the study medications.
- Receipt of live (including attenuated) vaccines during the study, or anticipation of need for such a vaccine during the study.
- History of primary idiopathic myelofibrosis or any severe marrow fibrosis that would prolong neutrophil engraftment to > 28 days after transplant.
- Post-transplant maintenance therapy for the hematologic malignancy or plans to initiate maintenance therapy during study treatment.
Trial locations and contacts
17 sites in 4 countries.
17 sites in 4 countries
United States9 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Anschutz Cancer Pavilion - University of Colorado
Aurora, Colorado, 80045
University of Maryland - Greenebaum Cancer Center
Baltimore, Maryland, 21201
The Ohio State University
Columbus, Ohio, 43210
John Theurer Cancer Center, Hackensack University Medical Center
Hackensack, New Jersey, 07601
Loyola University Medical Center
Maywood, Illinois, 60153
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Washington University School of Medicine
St Louis, Missouri, 63110
France3 sites
Chru de Lille Hopital Claude Huriez
Lille, 59037
Centre Hospitalier Universitaire de Nantes (Chu de Nantes) - Hotel-Dieu
Nantes, 44093
Chu Vandoeuvre-Les-Nancy, Hopital Brabois
Vandœuvre-lès-Nancy, 54500
Italy3 sites
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii (Presidio Papa Giovanni Xxiii)
Bergamo, 24127
Azienda Ospedaliera San Gerardo Di Monza
Monza, 20900
Comitato Di Bioetica Della Fondazione Irccs Policlinico San Matteo
Pavia, 27100
Spain2 sites
Hospital Puerta de Hierro
Majadahonda, 28222
Hospital Clinico Universitario de Valencia
Valencia, 46010
About this study
Official title: GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).
- Conditions
- Hematologic Malignancies
- Being tested
- Itacitinib, Calcineurin inhibitor
- Keywords
- Acute leukemia, chronic myelogenous leukemia, myelodysplasia, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B-cell, Hodgkin's lymphoma, mantle cell lymphoma, Janus kinase inhibitor, graft-versus-host disease
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Anemia, Refractory, with Excess of Blasts, Leukemia, Lymphocytic, Chronic, B-Cell, Hodgkin Disease, Lymphoma, Mantle-Cell, Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ItacitinibDrug
Also called INCB039110
Itacitinib administered orally once daily at the protocol-defined dose.
Calcineurin inhibitorDrug
The CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate, cyclosporine A/mycophenolate mofetil or tacrolimus plus post-treatment cyclophosphamide. Antithymocyte globulin may be included at the treating investigator's discretion with the tacrolimus/methotrexate or cyclosporine A/mycophenolate mofetil combinations.
| Study group | Role | What they receive |
|---|---|---|
| Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions | Experimental | Itacitinib in combination with a CNI-based intervention. Receives: Drug: Itacitinib; Drug: Calcineurin inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment
Hematologic recovery defined as demonstrating both neutrophil recovery (ANC ≥ 500/mm^3 for 3 consecutive measurements) and platelet recovery (platelet count ≥ 20,000/mm^3 with no requirement for platelet transfusion in the preceding 3 days).
Measured: Day 28
Secondary outcomes (11)
GVHD relapse-free survival rate
Defined as the proportion of subjects who do not experience Grade III-IV acute GVHD (aGVHD), chronic GVHD (cGVHD) requiring systemic therapy, malignancy relapse or progression, or death due to any cause.
Measured: Days 100, 180 and 365
Relapse-free survival
Defined as the interval between enrollment and malignancy relapse or progression, or death, whichever occurs first.
Measured: Up to 1 year
Transplant-related mortality
Defined as the proportion of subjects who die due to causes other than malignancy relapse or progression.
Measured: Up to 1 year
Median time to neutrophil and platelet engraftment
Defined as the median time to achieve neutrophil and platelet engraftment.
Measured: Up to Day 28
Percentage of participants who achieve neutrophil and platelet engraftment
Defined as the median time to achieve engraftment and hematologic recovery at prespecified time points.
Measured: Up to Day 28
Donor Chimerism
Measured: Up to Day 28
Proportion of subjects who are diagnosed with Grade II-IV aGVHD, by each grade and by Grade III/IV
Measured to assess the incidence of aGVHD.
Measured: Days 100 and Days 180
Proportion of subjects who are diagnosed with cGVHD by grade (mild, moderate, or severe)
Measured to assess the incidence of cGVHD.
Measured: Up to 1 year
Infection rate
Defined as the proportion of subjects who demonstrate an infection and/or cytomegalovirus reactivation.
Measured: Up to 1 year
Overall survival
Defined as the interval between enrollment and death due to any cause.
Measured: Up to 1 year
Participants with Grade 3-5 treatment-emergent adverse events (TEAEs)
TEAE is defined as either an adverse event (AE) reported for the first time or worsening of a pre-existing condition after the first dose of study treatment.
Measured: Up to approximately 200 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2017
- Study start27 Feb 2018
- Primary completion25 Feb 2021
- Study completion17 Feb 2022
Why it stopped: Study terminated by sponsor
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic MalignanciesStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Incyte Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rodica Morariu-Zamfir, MD, Study director, Incyte Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03320642
- Sponsor's protocol ID
- INCB 39110-119/GRAVITAS-119
- Other IDs
- 2017-002922-19, 2017
- Status last verified
- Oct 2025
- First submitted
- 16 Oct 2017
- Last updated
- 21 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRAVITAS-119: A Single-Arm, Open-Label, Phase 1 Study of Itacitinib in Combination With Calcineurin Inhibitor-Based Interventions for the Prophylaxis of Graft-Versus Host Disease
- ClinicalTrials.gov ID
- NCT03320642
- Acronym / sponsor ID
- INCB 39110-119/GRAVITAS-119
- Conditions
- Hematologic Malignancies
- Keywords
- Acute leukemia, chronic myelogenous leukemia, myelodysplasia, chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B-cell, Hodgkin's lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study terminated by sponsor
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Incyte CorporationIndustry (pharma, biotech, devices)
- Study start
- 27 Feb 2018 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 17 Feb 2022 (actual)
- First posted
- 25 Oct 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.
The purpose of this study is to assess the impact and safety of itacitinib in combination with calcineurin inhibitor (CNI)-based interventions for the prophylaxis of graft-versus-host-disease (GVHD).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions | Experimental | Drug: Itacitinib, Drug: Calcineurin inhibitorItacitinib in combination with a CNI-based intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with acute leukemia, chronic myelogenous leukemia, or myelodysplasia with no circulating blasts and < 5% blasts in the bone marrow.
- Subjects with non-Hodgkin lymphoma, including but not limited to chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, or mantle cell lymphoma must have chemosensitive disease at time of transplant. Subjects with Hodgkin lymphoma with chemosensitive disease at the time of transplant.
- Must be candidates for reduced-intensity conditioning regimens.
- Must be candidates for peripheral blood stem cell transplants.
- Karnofsky Performance Status score ≥ 70% or Eastern Cooperative Oncology Group Performance Status score of 0 to 2.
Key exclusion criteria (12 listed)
- Has previously received an allogenic hematopoietic stem cell transplant.
- Presence of an active uncontrolled infection.
- Known HIV infection.
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection that requires treatment or at risk for HBV reactivation.
- Prior malignancies.
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 |
|---|---|---|
| ItacitinibAlso: INCB039110Itacitinib administered orally once daily at the protocol-defined dose. | Drug | Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions |
| Calcineurin inhibitorThe CNI-based prophylaxis regimen will be identified by the investigator before the subject's enrollment and will consist of the combination of tacrolimus/methotrexate, cyclosporine A/mycophenolate mofetil or tacrolimus plus post-treatment cyclophosphamide. Antithymocyte globulin may be included at the treating investigator's discretion with the tacrolimus/methotrexate or cyclosporine A/mycophenolate mofetil combinations. | Drug | Itacitinib + Calcineurin Inhibitor (CNI) -Based Interventions |
Primary outcome
Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment
Time frame: Day 28
Hematologic recovery defined as demonstrating both neutrophil recovery (ANC ≥ 500/mm^3 for 3 consecutive measurements) and platelet recovery (platelet count ≥ 20,000/mm^3 with no requirement for platelet transfusion in the preceding 3 days).
11 secondary outcomes
GVHD relapse-free survival rate
Time frame: Days 100, 180 and 365
Relapse-free survival
Time frame: Up to 1 year
Transplant-related mortality
Time frame: Up to 1 year
Median time to neutrophil and platelet engraftment
Time frame: Up to Day 28
Percentage of participants who achieve neutrophil and platelet engraftment
Time frame: Up to Day 28
Donor Chimerism
Time frame: Up to Day 28
Proportion of subjects who are diagnosed with Grade II-IV aGVHD, by each grade and by Grade III/IV
Time frame: Days 100 and Days 180
Proportion of subjects who are diagnosed with cGVHD by grade (mild, moderate, or severe)
Time frame: Up to 1 year
Infection rate
Time frame: Up to 1 year
Overall survival
Time frame: Up to 1 year
Participants with Grade 3-5 treatment-emergent adverse events (TEAEs)
Time frame: Up to approximately 200 days
Results and safety
The study was stopped early (reason given: Study terminated by sponsor). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2025.
- Individual participant dataSharing planned: No
Related trials for Hematologic Malignancies
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
Active, not recruitingPhase 1/2
A Window of Opportunity Trial to Learn if Linvoseltamab is Safe and Well Tolerated, and How Well it Works in Adult Participants With Recently Diagnosed Multiple Myeloma Who Have Not Already Received Treatment
Multiple Myeloma
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.
Rodica Morariu-Zamfir, MD study director
Incyte Corporation
17 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Itacitinib and Calcineurin inhibitor in people with Hematologic Malignancies, run by Incyte Corporation at 17 sites in 4 countries.
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 7 inclusion and 12 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 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States, France, Italy, Spain. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Study terminated by sponsor). 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?
Proportion of participants with hematologic recovery when itacitinib is added to GVHD prophylaxis treatment (time frame: Day 28). It is what the study was designed to measure, not a finding.
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 21 Oct 2025.