Primary Central Nervous System Lymphoma (PCNSL)Phase 1NCT07082868
A Study of Epcoritamab and Ibrutinib in People With Central Nervous System Lymphoma (CNSL)
A Phase 1 study testing ibrutinib and Epcoritamab in people with Primary Central Nervous System Lymphoma (PCNSL) and Primary Central Nervous System Lymphoma, run by Memorial Sloan Kettering Cancer Center at 8 sites in United States.
Trial summary
The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Central Nervous System Lymphoma (PCNSL), Primary Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma
- What is being tested?
- ibrutinib and Epcoritamab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 8 sitesUnited States
- Study dates
- 13 Aug 2025to Aug 2028
- Phase
- Phase 1
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >/= 18 years of age on the day of consenting to the study.
- Histologically documented DLBCL at enrolling institution (biopsy or CSF samples in PCNSL; biopsy of CNS or non-CNS sample in SCNSL)
- Participants must have an ECOG performance status of 0, 1, or 2.
- Participants must have adequate bone marrow and organ function shown by:
- Absolute neutrophil count (ANC) ≥ 1 x 109/L
- Platelets ≥ 75 x 109/L and no platelet transfusion within the past 21 days prior to study consent
Show all 15Show fewer
- Hemoglobin (Hgb) ≥ 8 g/dL and no red blood cell (RBC) transfusion within the past 21 days prior to study consent
- International Normalized Ratio (INR) ≤ 1.5 and PTT (aPTT) ≤ 1.5 times the upper limit of normal (unless receiving anticoagulation)
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 3 times the upper limit of normal
- Serum bilirubin ≤ 1.5 times the upper limit of normal; or total bilirubin ≤ 3 times the upper limit of normal with direct bilirubin within the normal range in patients with well documented Gilbert Syndrome.
- Creatinine clearance (CLCr) ≥ 40 ml/min (based on the following formular Creatinine clearance= ((140-age)*wt)/(creatinine*72); multiply by 0.85 for women)
- Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after the last dose
- Female subjects of childbearing potential must have a negative serum pregnancy test upon study entry. See section on Pregnancy and Reproduction.
- Patients must be able to tolerate MRI/CT scans.
- Due to the nature of this disease, we will allow patients with impaired decision-making ability to enroll into all cohorts.
Who cannot join
- Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded.
- Patients with existing chronic moderate and severe hepatic impairment (Child-Pugh class B or C) are excluded
- Patient is concurrently using other approved or investigational antineoplastic agents.
- Patient has an active concurrent malignancy requiring active therapy
- Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.
- Patient has received external beam radiation therapy to the CNS within 21 days of the first dose of the study drug.
Show all 50Show fewer
- Patient requires more than 8 mg of dexamethasone daily or the equivalent
- Patient is using warfarin or any other warfarin-derivative anticoagulant or vitamin K antagonists. Patients must be off warfarin-derivative anticoagulants for at least seven days prior to starting the study drug. Low molecular weight heparin is allowed. Patients with congenital bleeding diathesis are excluded.
- Subject has consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit within 3 days prior to initiation of study therapy
- Patient is taking a drug known to be a moderate or strong inhibitor or inducers of the P450 isoenzyme CYP3A. Participants must be off P450/CYP3A inhibitors and inducers for at least 5 half-lives or at least two weeks, whichever is shorter, prior to starting the study drug.
- Patient is using systemic immunosuppressant therapy, including cyclosporine A, tacrolimus, sirolimus, and other such medications, or chronic administration of > 5 mg/day of prednisone or the equivalent (for more than 12 months). Participants must be off of immunosuppressant therapy for at least 28 days prior to the first dose of the study drug.
- Patient has significant abnormalities on screening electrocardiogram (EKG) and active and significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, hypertension, valvular disease, pericarditis, or myocardial infarction within 6 months of screening
- Patient has an ejection fraction of <50%
- Patient has a known bleeding diathesis (e.g. von Willebrand's disease) or hemophilia.
- Patient is documented to have human immunodeficiency virus (HIV) infection.
- Patient is documented to have a history of active or chronic infection with hepatitis C virus (HCV) or hepatitis B virus (HBV) as determined by serologic tests.
- Patient is known to have an uncontrolled active systemic infection.
- Patient is unable to swallow capsules or has a disease or condition significantly affecting gastrointestinal function, such as malabsorption syndrome, resection of the stomach or small bowel, or complete bowel obstruction.
- Patient has a life-threatening illness, medical condition, or organ system dysfunction that, in the opinion of the investigator, could compromise the subject's safety or put the study outcomes at undue risk.
- Patient has not received vaccination with live vaccines within 28 days prior to first dose of study drug or is expected to need any live vaccination during study participation including at least 3 months following the last dose of study treatment. Note: COVID-19 non-replicating adenoviral vaccines are permitted with a minimum period of 3 days between the vaccine and a dose of study drug. It is highly recommended that every patient enrolled onto this trial has updated vaccination status (e.g. flu, hepatitis, polio, pertussis, tetanus; when is doubt please contact the PI or side-PI).
- Women who are pregnant or nursing (lactating), where pregnancy is defined as a state of a female after conception until the termination of gestation, confirmed by a positive serum hCG laboratory test of > 5 mIU/mL
- Pregnancy and Reproduction
- Women:
- Women are considered post-menopausal and not of childbearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (i.e. age appropriate, history of vasomotor symptoms) or six months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL and estradiol < 20 pg/mL or have had surgical bilateral oophorectomy with or without hysterectomy at least six weeks prior to enrollment in the study. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up of hormone level assessment is she considered not of childbearing potential.
- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, must use highly effective contraception during study treatment and for 4 months after study discontinuation. Highly effective contraception is defined as either
- True abstinence: When this is the line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception
- Sterilization: Surgical bilateral oophorectomy, with or without hysterectomy, or tubal ligation at least six weeks prior to study enrollment.
- Male partner sterilization (with appropriate post-vasectomy documentation of the absence of sperm in the ejaculate). For female patients participating in the study, the vasectomized male partner should be the sole partner for that patient.
- Use of a combination of any two of the following:
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: Condom or occlusive cap (diaphragm or cervical vault caps) with spermicidal form/gel/film/cream/vaginal suppository
- Women of child-bearing potential must have one negative serum pregnancy tests at screening
- In addition to having a negative pregnancy test confirmed at screening, all female participants of child bearing potential must have a negative pregnancy test confirmed within 48 hours prior to dosing with the study drug.
- Men:
- Fertile males, defined as all male subjects physiologically capable of conceiving offspring, must use a condom during study treatment and for 12 months after study discontinuation and should not father a child in this period.
- Female partner of a male study subject should use a highly effective method of contraception while the male partner is receiving the study agent and for 12 months after the final dose of the study therapy.
- Inclusion of women, minorities or other underrepresented populations
- Ibrutinib and epcoritamab are not known to differentially affect subpopulations, including women, minorities, or other underrepresented groups. The eligibility and exclusion criteria are not expected to differentially impact recruitment or retention of these subpopulations.
- Covid-19 eligibility criteria
- Subject has no known active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. If a subject has signs/symptoms suggestive of SARS-CoV-2 infection or have had recent known exposure to someone with SARS-CoV-2 infection, the subject must have a negative molecular (e.g., PCR) test, or 2 negative antigen test results at least 24 hours apart, to rule out SARS-CoV-2 infection.
- Subjects who do not meet SARS-CoV-2 infection eligibility criteria must be screen failed and may only rescreen after they meet the following SARS-CoV-2 infection viral clearance criteria:
- No signs/symptoms suggestive of active SARS-CoV-2 infection
- Negative molecular (e.g., PCR) result or 2 negative antigen test results at least 24 hours apart
- Given the ongoing COVID-19 pandemic, selected non-live vaccines (e.g. mRNA, non-replicating viral vector, protein subunit, etc.) to prevent SARS-CoV-2 infections may be administered during screening or the treatment period, as long as components of the vaccine are not contraindicated. COVID-19 vaccines are permitted and strongly recommended.
- The decision to receive a locally available vaccine should be based on local guidance and an individual discussion between the treating physician and the subject.
- The potential impact of epcoritamab on SARS-CoV-2 vaccination is unknown. Therefore, study drug should be administered as follows:
- The first dose of study drug, when possible, is preferred to be given at least 14 days from SARS-CoV-2 vaccine administration.
- A minimum period of 3 days must occur between the administration of an appropriate COVID-19 vaccine and the administration od epcoritamab (to avoid overlapping AEs).
- Note: The above guidance applies to all SARS-CoV-2 vaccine doses given as part of the complete vaccination course.
- These recommendations may be subject to change based on the evolving knowledge around the use of SARS-Cov-2 vaccines in subjects with recurrent/refractory DLBCL or cFL and as more data are collected in real-world scenarios and clinical trials.
Trial locations and contacts
8 sites in 1 country. Contact the study team or a site near you to ask about taking part.
8 sites in 1 country
United States8 sites, 8 recruiting
- Recruiting
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Christian Grommes, MD, 212-610-0344
- Recruiting
Memorial Sloan Kettering Commack (Limited Protocol Activities)
Commack, New York, 11725
Christian Grommes, MD, 212-610-0344
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Christian Grommes, MD, 212-610-0344
- Recruiting
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, 07748
Christian Grommes, MD, 212-610-0344
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Christian Grommes, MD, 212-610-0344
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Christian Grommes, MD, 212-610-0344
- Recruiting
University of Utah (Data Collection Only)
Salt Lake City, Utah, 84112
Narendranath Epperia, MD, MS, FACP, 801-585-2626
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale, New York, 11553
Christian Grommes, MD, 212-610-0344
About this study
Official title: A Phase Ib Trial With Dose Expansion of Epcoritamab in Combination With Ibrutinib in Refractory/Recurrent CNS Lymphoma (EIFEL-Trial)
The purpose of this study is to find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).
- Conditions
- Primary Central Nervous System Lymphoma (PCNSL), Primary Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma, Refractory Primary Central Nervous System Lymphoma, Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma
- Being tested
- ibrutinib, Epcoritamab
- Keywords
- Primary Central Nervous System Lymphoma, PCNSL, Relapsed Primary Central Nervous Lymphoma, Refractory Primary Central Nervous Lymphoma, Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma, SCNSL, epcoritamab, ibrutinib, 25-032, Memorial Sloan Kettering Cancer Center
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ibrutinibDrug
Ibrutinib should be self-administered daily by the participant and should be taken at approximately the same time each day
EpcoritamabDrug
Epcoritamab will be administered at the study site clinic, as a SC injection
| Study group | Role | What they receive |
|---|---|---|
| Cohort A | Experimental | Relapsed or refractory PCNSL (n=6) Receives: Drug: ibrutinib; Drug: Epcoritamab |
| Cohort B1 | Experimental | Relapsed or refractory PCNSL (n=10) Receives: Drug: ibrutinib; Drug: Epcoritamab |
| Cohort B2 | Experimental | Relapsed or refractory PCNSL (n=10) Receives: Drug: ibrutinib; Drug: Epcoritamab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of dose limiting toxicities/DLTs
Cohort A - To determine the safety and tolerability of epcoritamab in combination with ibrutinib in CNS lymphoma patients
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start13 Aug 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Central Nervous System Lymphoma (PCNSL)Studies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 26 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian Grommes, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07082868
- Sponsor's protocol ID
- 25-032
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib Trial With Dose Expansion of Epcoritamab in Combination With Ibrutinib in Refractory/Recurrent CNS Lymphoma (EIFEL-Trial)
- ClinicalTrials.gov ID
- NCT07082868
- Acronym / sponsor ID
- 25-032
- Conditions
- Primary Central Nervous System Lymphoma (PCNSL), Primary Central Nervous System Lymphoma, Relapsed Primary Central Nervous System Lymphoma, Refractory Primary Central Nervous System Lymphoma, Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma
- Keywords
- Primary Central Nervous System Lymphoma, PCNSL, Relapsed Primary Central Nervous Lymphoma, Refractory Primary Central Nervous Lymphoma, Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma, SCNSL, epcoritamab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 26 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 13 Aug 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 24 Jul 2025 (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 find out whether the combination of epcoritamab and ibrutinib is a safe treatment approach that causes few or mild side effects in people with relapsed/refractory primary central nervous system lymphoma (PCNSL) or secondary central nervous system lymphoma (SCNSL).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort A | Experimental | Drug: ibrutinib, Drug: EpcoritamabRelapsed or refractory PCNSL (n=6) |
| Cohort B1 | Experimental | Drug: ibrutinib, Drug: EpcoritamabRelapsed or refractory PCNSL (n=10) |
| Cohort B2 | Experimental | Drug: ibrutinib, Drug: EpcoritamabRelapsed or refractory PCNSL (n=10) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- >/= 18 years of age on the day of consenting to the study.
- Histologically documented DLBCL at enrolling institution (biopsy or CSF samples in PCNSL; biopsy of CNS or non-CNS sample in SCNSL)
- Participants must have an ECOG performance status of 0, 1, or 2.
- Participants must have adequate bone marrow and organ function shown by:
- Women of reproductive potential must agree to use highly effective methods of birth control during the period of therapy and for 30 days after the last dose of the study drug. Men who are sexually active must agree to use highly effective contraception during the period of therapy and for 3 months after the last dose
Key exclusion criteria (50 listed)
- Newly diagnosed PCNSLs or SCNSLs and patients with non-CNS disease are excluded.
- Patients with existing chronic moderate and severe hepatic impairment (Child-Pugh class B or C) are excluded
- Patient is concurrently using other approved or investigational antineoplastic agents.
- Patient has an active concurrent malignancy requiring active therapy
- Patient has received chemotherapy, monoclonal antibodies or targeted anticancer therapy ≤ 4 weeks or 5 half-lives, whichever is shorter, or 6 weeks for nitrosourea or mitomycin-C prior to starting the study drug, or the patient has not recovered from the side effects of such therapy.
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 |
|---|---|---|
| ibrutinibIbrutinib should be self-administered daily by the participant and should be taken at approximately the same time each day | Drug | Cohort A, Cohort B1, Cohort B2 |
| EpcoritamabEpcoritamab will be administered at the study site clinic, as a SC injection | Drug | Cohort A, Cohort B1, Cohort B2 |
Primary outcome
Number of dose limiting toxicities/DLTs
Time frame: 8 weeks
Cohort A - To determine the safety and tolerability of epcoritamab in combination with ibrutinib in CNS lymphoma patients
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 14 Jul 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Related trials for Primary Central Nervous System Lymphoma (PCNSL)
RecruitingPhase 2
Ibrutinib Combination Therapy in Transplant Ineligible Individuals With Newly Diagnosed Primary CNS Lymphoma
Non-hodgkin Lymphoma
RecruitingPhase 1
Glofitamab With Obinutuzumab Pre-treatment for the Treatment of Central Nervous System Lymphoma
Primary Central Nervous System Lymphoma, Secondary Central Nervous System Lymphoma
RecruitingPhase 2
A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma
Lymphoma
RecruitingPhase 1
Phase Ib Clinical Study of Keynatinib
Lymphoma, B-Cell
RecruitingPhase 3
IGNITE: Study of Tirabrutinib vs Rituximab and Temozolomide for Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
Relapsed/Refractory Primary Central Nervous System Lymphoma
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.
Christian Grommes, MD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing ibrutinib and Epcoritamab in people with Primary Central Nervous System Lymphoma (PCNSL) and Primary Central Nervous System Lymphoma, run by Memorial Sloan Kettering Cancer Center at 8 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 15 inclusion and 50 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: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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.
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?
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?
Contact Christian Grommes, MD (212-610-0344, grommesc@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of dose limiting toxicities/DLTs (time frame: 8 weeks). 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 14 Jul 2026.