Hematologic and Lymphocytic DisorderPhase 2NCT04859946
Itacitinib for the Prevention of Graft Versus Host Disease
A Phase 2 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan and Cyclophosphamide in people with Hematologic and Lymphocytic Disorder, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hematologic and Lymphocytic Disorder
- What is being tested?
- Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan and Cyclophosphamide
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2022to 1 Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years to less than or equal to 70 years
- English and non-English speaking patients are eligible
- Karnofsky performance status of at least 70
- Patients with hematological disorders undergoing allogeneic stem cell transplant (ASCT) with conditioning regimen of fractionated busulfan, thiotepa and fludarabine
- Donor will be matched at HLA A, B, C and DR at allele level. Donor will be either HLA-identical sibling or at least 7/8 matched unrelated donor, or a haploidentical related donor available.
- Life expectancy of at least 12 weeks (3 months)
Show all 19Show fewer
- Direct bilirubin not greater than 1 mg/dL
- Alanine transaminase (ALT) less than or equal 3 x upper limit of normal range
- Creatinine clearance >/= 60 ml/ min
- Diffusing capacity for carbon monoxide (DLCO) 50% of predicted corrected for hemoglobin
- Left ventricular ejection fraction (LVEF) of at least 50%
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of study drug. Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test
- Subjects (men and women) of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 30 days after the last dose of study drug. Recommended methods of birth control are:
- Hormonal contraception (birth control pills, patches, or rings)
- Intrauterine device (IUD)
- Birth control injections
- Double barrier methods (diaphragm with spermicidal gel or condoms with birth control foam)
- Sterilization of patient or partner ("tubes tied" or vasectomy)
- Patients enrolled on this study may be enrolled on other IND studies at the discretion of the PI
Who cannot join
- Patients with acute leukemia in the first complete remission and chronic myeloid leukemia in the first chronic phase during the initial enrollment of 6 patients
- Patients with toxicities (Grade > 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery)
- Haploidentical recipients should not have donor-specific antibodies (DSA)
- Active or clinically significant cardiac disease including:
- Congestive heart failure - New York Heart Association (NYHA) > class II
- Active coronary artery disease
Show all 10Show fewer
- Cardiac arrhythmias requiring anti-arrhythmic therapy other than beta blockers or digoxin
- Unstable angina (anginal symptoms at rest), new-onset angina within 3 months before transplant, or myocardial infarction within 6 months before transplant
- Patients with active hepatitis B and C
- Patients with cognitive impairments and/or any serious unstable pre-existing medical condition or psychiatric disorder that can interfere with safety or with safety or with obtaining informed consent or compliance with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Itacitinib to Prevent Graft Versus Host Disease
This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.
Read the detailed description
PRIMARY OBJECTIVE:
- To compare the 100-day acute grade 2-4 GvHD rate to matched controls.
SECONDARY OBJECTIVES:
- To compare the 1-year rate of GvHD-free, relapse-free survival to matched controls.
II. To assess the time to neutrophil and platelet engraftment. III. To assess the toxicity profile associated with this regimen. IV. To assess the incidence of severe grade 3-4 acute GVHD. V. To assess the incidence of limited, extensive, and moderate to severe chronic GVHD.
VI. To assess the incidence of disease relapse. VII. To assess the incidence of non-relapse mortality. VIII. To assess overall survival and progression-free survival. IX. To assess immunosuppression discontinuation rate.
TERTIARY OBJECTIVE (CORRELATIVE STUDY):
- Immune recovery and cytokines at various time points pre- and post- transplant
OUTLINE:
CONDITIONING: Patients receive busulfan intravenously (IV) over 3 hours on days -20, -13, and -6 to -3, thiotepa IV on day -7, and fludarabine IV over 1 hour on days -6 to -3.
STEM CELL TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4. Patients also receive itacitinib orally (PO) once daily (QD) on days 5-60 in the absence of disease progression or unacceptable toxicity. Beginning day 5 after stem cell transplant, patients also receive tacrolimus IV over 24 hours until able to tolerate oral tacrolimus, whereby patients then receive tacrolimus PO twice daily (BID).
After completion of study intervention, patients are followed up at days 100, 180, and 365 after stem cell transplant.
- Conditions
- Hematologic and Lymphocytic Disorder
- Being tested
- Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan, Cyclophosphamide, Fludarabine, Itacitinib
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery
Also called Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSC
Undergo stem cell transplant
BusulfanDrug
Also called 1, 4-Bis[methanesulfonoxy]butane, BUS, Bussulfam, Busulfanum
Given IV
CyclophosphamideDrug
Also called (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida
Given IV
FludarabineDrug
Also called Fluradosa
Given IV
ItacitinibDrug
Also called INCB 039110, INCB-039110, INCB039110
Given PO
TacrolimusDrug
Also called FK 506, Fujimycin, Hecoria, Prograf
Given IV or PO
ThiotepaDrug
Also called 1,1'',1''''-Phosphinothioylidynetrisaziridine, Girostan, N,N'', N''''-Triethylenethiophosphoramide, Oncotiotepa
Given IV
| Study group | Role | What they receive |
|---|---|---|
| Supportive care (itacitinib) | Experimental | CONDITIONING: Patients receive busulfan IV over 3 hours on days -20, -13, and -6 to -3, thiotepa IV on day -7, and fludarabine IV over 1 hour on days -6 to -3.
STEM CELL TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4. Patients also receive itacitinib PO QD on days 5-60 in the absence of disease progression or unacceptable toxicity. Beginning day 5 after stem cell transplant, patients also receive tacrolimus IV over 24 hours until able to tolerate oral tacrolimus, whereby patients then receive tacrolimus PO BID. Receives: Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Drug: Busulfan; Drug: Cyclophosphamide; Drug: Fludarabine; Drug: Itacitinib; Drug: Tacrolimus; Drug: Thiotepa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute grade 2-4 graft versus host disease (GVHD)
The 100-day acute grade 2-4 GvHD rate will be compared between groups using Fisher's exact test. Matched logistic regression techniques will also be considered for this endpoint. The proportion of patients with acute grade 2-4 GVHD at 100 days will be reported, along with the corresponding 95% confidence interval.
Measured: At 100 days after stem cell transplant
Secondary outcomes (8)
GVHD-free relapse-free survival
Will be compared between groups using the log-rank test. The method of Kaplan and Meier will be used to estimate the distribution of GVHD-free, relapse-free survival. The estimated probability will be reported at 1 year along with a corresponding 95% confidence interval. In addition, Cox proportional hazards regression models will be fit to this endpoint, considering clinical, demographic, and treatment covariates of interest.
Measured: From day of stem cell transplant to time of grade 3 or 4 acute GVHD or chronic GVHD needing systemic immunosuppression or relapse or death whichever occurs first, assessed at 1 year after stem cell transplant
Time to neutrophil and platelet engraftment
Engraftment is defined as the presence of neutrophil recovery by day 28 post stem cell infusion. Neutrophil recovery is defined as a sustained absolute neutrophil count (ANC) > 0.5 x 10^9/L for three consecutive days.
Initial platelet recovery is defined as the first date of three consecutive laboratory values obtained for platelet count was >= 20 x 10^9/L AND no platelet transfusions were administered for seven consecutive days immediately preceding this date. Will be calculated from the time of transplant and estimated by the Kaplan-Meier method. Distributions will be compared between patients with matched and mismatched donors via the log-rank test.
Measured: Up to 365 days after stem cell transplant
Overall survival
Will be calculated from the time of transplant by the method of Kaplan and Meier. Cox proportional hazards regression analysis will be used to assess the association between these survival parameters and clinical and treatment covariates of interest.
Measured: From day of stem cell transplant to day of death, assessed up to 365 days after stem cell transplant
Progression-free survival
Will be calculated from the time of transplant by the method of Kaplan and Meier. Cox proportional hazards regression analysis will be used to assess the association between these survival parameters and clinical and treatment covariates of interest.
Measured: From day of transplant to day of death or disease progression, assessed up to 365 days after stem cell transplant
Time to relapse
Measured: Up to 365 days after stem cell transplant
Non-relapse mortality
Defined as death from any cause other than relapse disease.
Measured: Up to 365 days after stem cell transplant
Cumulative incidence of limited, extensive, and moderate to severe chronic GVHD
The cumulative incidence of acute and chronic GVHD with the competing risk of relapse and death without relapse will be estimated using the method of Gooley, and the method of Fine and Gray will be used to model the incidence by disease and clinical characteristics of interest.
Measured: Up to 365 days after stem cell transplant
Incidence of adverse events
Descriptive statistics will be used to summarize adverse events. Frequency counts and percentages will also be presented of subjects with serious adverse events and adverse events leading to withdrawal. All other safety parameters will be summarized using descriptive statistics or frequency counts. Graphical summaries will be used where appropriate.
Measured: Up to 365 days after stem cell transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start11 Jan 2022
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic and Lymphocytic DisorderStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Sponsor
- Investigators
- Uday R Popat, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859946
- Sponsor's protocol ID
- 2020-0971
- Other IDs
- NCI-2021-02784, 2020-0971
- Status last verified
- Oct 2026
- First submitted
- 22 Apr 2021
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Itacitinib to Prevent Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT04859946
- Acronym / sponsor ID
- 2020-0971
- Conditions
- Hematologic and Lymphocytic Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 11 Jan 2022 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 26 Apr 2021 (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.
This phase II trial studies if itacitinib plus standard of care treatment may help prevent graft-versus-host-disease (GVHD) in patients who have received an allogeneic (donor) stem cell transplant. An allogeneic transplant uses blood-making cells from a family member or unrelated donor to remove and replace a patient's abnormal blood cells. Sometimes the transplanted cells from a donor can attack the body's normal cells (called graft-versus-host disease). Giving itacitinib with standard of care treatment after the transplant may stop this from happening.
Detailed description
PRIMARY OBJECTIVE:
- To compare the 100-day acute grade 2-4 GvHD rate to matched controls.
SECONDARY OBJECTIVES:
- To compare the 1-year rate of GvHD-free, relapse-free survival to matched controls.
II. To assess the time to neutrophil and platelet engraftment. III. To assess the toxicity profile associated with this regimen. IV. To assess the incidence of severe grade 3-4 acute GVHD. V. To assess the incidence of limited, extensive, and moderate to severe chronic GVHD.
VI. To assess the incidence of disease relapse. VII. To assess the incidence of non-relapse mortality. VIII. To assess overall survival and progression-free survival. IX. To assess immunosuppression discontinuation rate.
TERTIARY OBJECTIVE (CORRELATIVE STUDY):
- Immune recovery and cytokines at various time points pre- and post- transplant
OUTLINE:
CONDITIONING: Patients receive busulfan intravenously (IV) over 3 hours on days -20, -13, and -6 to -3, thiotepa IV on day -7, and fludarabine IV over 1 hour on days -6 to -3.
STEM CELL TRANSPLANT: Patients undergo stem cell transplant on day 0.
GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4. Patients also receive itacitinib orally (PO) once daily (QD) on days 5-60 in the absence of disease progression or unacceptable toxicity. Beginning day 5 after stem cell transplant, patients also receive tacrolimus IV over 24 hours until able to tolerate oral tacrolimus, whereby patients then receive tacrolimus PO twice daily (BID).
After completion of study intervention, patients are followed up at days 100, 180, and 365 after stem cell transplant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Supportive care (itacitinib) | Experimental | Procedure: Allogeneic Hematopoietic Stem Cell Transplantation, Drug: Busulfan, Drug: Cyclophosphamide, Drug: Fludarabine, Drug: Itacitinib, Drug: Tacrolimus, Drug: ThiotepaCONDITIONING: Patients receive busulfan IV over 3 hours on days -20, -13, and -6 to -3, thiotepa IV on day -7, and fludarabine IV over 1 hour on days -6 to -3. STEM CELL TRANSPLANT: Patients undergo stem cell transplant on day 0. GVHD PROPHYLAXIS: Patients receive cyclophosphamide IV over 3 hours on days 3 and 4. Patients also receive itacitinib PO QD on days 5-60 in the absence of disease progression or unacceptable toxicity. Beginning day 5 after stem cell transplant, patients also receive tacrolimus IV over 24 hours until able to tolerate oral tacrolimus, whereby patients then receive tacrolimus PO BID. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patients 18 years to less than or equal to 70 years
- English and non-English speaking patients are eligible
- Karnofsky performance status of at least 70
- Patients with hematological disorders undergoing allogeneic stem cell transplant (ASCT) with conditioning regimen of fractionated busulfan, thiotepa and fludarabine
- Donor will be matched at HLA A, B, C and DR at allele level. Donor will be either HLA-identical sibling or at least 7/8 matched unrelated donor, or a haploidentical related donor available.
Key exclusion criteria (10 listed)
- Patients with acute leukemia in the first complete remission and chronic myeloid leukemia in the first chronic phase during the initial enrollment of 6 patients
- Patients with toxicities (Grade > 1) unresolved from prior treatment (including chemotherapy, targeted therapy, immunotherapy, experimental agents, radiation, or surgery)
- Haploidentical recipients should not have donor-specific antibodies (DSA)
- Active or clinically significant cardiac disease including:
- Patients with active hepatitis B and C
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 |
|---|---|---|
| Allogeneic Hematopoietic Stem Cell TransplantationAlso: Allogeneic, Allogeneic Hematopoietic Cell Transplantation, Allogeneic Stem Cell Transplantation, HSCUndergo stem cell transplant | Procedure or surgery | Supportive care (itacitinib) |
| BusulfanAlso: 1, 4-Bis[methanesulfonoxy]butane, BUS, Bussulfam, BusulfanumGiven IV | Drug | Supportive care (itacitinib) |
| CyclophosphamideAlso: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, CiclofosfamidaGiven IV | Drug | Supportive care (itacitinib) |
| FludarabineAlso: FluradosaGiven IV | Drug | Supportive care (itacitinib) |
| ItacitinibAlso: INCB 039110, INCB-039110, INCB039110Given PO | Drug | Supportive care (itacitinib) |
| TacrolimusAlso: FK 506, Fujimycin, Hecoria, PrografGiven IV or PO | Drug | Supportive care (itacitinib) |
| ThiotepaAlso: 1,1'',1''''-Phosphinothioylidynetrisaziridine, Girostan, N,N'', N''''-Triethylenethiophosphoramide, OncotiotepaGiven IV | Drug | Supportive care (itacitinib) |
Primary outcome
Incidence of acute grade 2-4 graft versus host disease (GVHD)
Time frame: At 100 days after stem cell transplant
The 100-day acute grade 2-4 GvHD rate will be compared between groups using Fisher's exact test. Matched logistic regression techniques will also be considered for this endpoint. The proportion of patients with acute grade 2-4 GVHD at 100 days will be reported, along with the corresponding 95% confidence interval.
8 secondary outcomes
GVHD-free relapse-free survival
Time frame: From day of stem cell transplant to time of grade 3 or 4 acute GVHD or chronic GVHD needing systemic immunosuppression or relapse or death whichever occurs first, assessed at 1 year after stem cell transplant
Time to neutrophil and platelet engraftment
Time frame: Up to 365 days after stem cell transplant
Overall survival
Time frame: From day of stem cell transplant to day of death, assessed up to 365 days after stem cell transplant
Progression-free survival
Time frame: From day of transplant to day of death or disease progression, assessed up to 365 days after stem cell transplant
Time to relapse
Time frame: Up to 365 days after stem cell transplant
Non-relapse mortality
Time frame: Up to 365 days after stem cell transplant
Cumulative incidence of limited, extensive, and moderate to severe chronic GVHD
Time frame: Up to 365 days after stem cell transplant
Incidence of adverse events
Time frame: Up to 365 days after stem cell transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
Related trials for Hematologic and Lymphocytic Disorder
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
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
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.
Uday R Popat, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Hematopoietic Stem Cell Transplantation, Busulfan and Cyclophosphamide in people with Hematologic and Lymphocytic Disorder, run by M.D. Anderson Cancer Center 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 19 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 7 Oct 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of acute grade 2-4 graft versus host disease (GVHD) (time frame: At 100 days after stem cell transplant). 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 7 Oct 2026.