Post-transplant Lymphoproliferative DisorderPhase 1/2PLUTONCT07573436
Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
A Phase 1/2 study testing Loncastuximab tesirine and Rituximab or rituximab biosimilar in people with Post-transplant Lymphoproliferative Disorder, run by University of Utah at 1 site in United States.
Trial summary
The purpose of phase I of this clinical trial is to learn the recommended dose of the drugs loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-transplant Lymphoproliferative Disorder
- What is being tested?
- Loncastuximab tesirine and Rituximab or rituximab biosimilar
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Jun 2031
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject aged ≥ 18 years.
- Histologically confirmed B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; with or without EBV association.
- --Note: Subjects with classic Hodgkin-like PTLD are excluded.
- Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening
- ECOG Performance Status ≤ 2.
- Adequate organ function as defined as:
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- Hematologic:
- Absolute neutrophil count (ANC) ≥ 1000/mm3
- Platelet count ≥ 75,000/mm3
- Hemoglobin ≥ 8 g/dL
- Hepatic:
- Bilirubin ≤1.5 x upper limit of normal (ULN) or ≤3 x ULN with document liver involvement and/ or Gilbert's disease
- Transaminases (AST or ALT) ≤ 3 x ULN or ≤ 5 x ULN with documented liver involvement
- Renal:
- Estimated creatinine clearance ≥ 60 mL/min by Cockcroft-Gault formula.
- For female subjects: Negative pregnancy test or evidence of post-menopausal status. The post-menopausal status will be defined as having been amenorrheic for 12 months without an alternative medical cause or having undergone surgical sterilization (bilateral oophorectomy or hysterectomy). The following age-specific requirements apply:
- Women < 50 years of age:
- Amenorrheic for ≥ 12 months following cessation of exogenous hormonal treatments; and
- Luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution; or
- Underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
- Women ≥ 50 years of age:
- Amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments; or
- Had radiation-induced menopause with last menses >1 year ago; or
- Had chemotherapy-induced menopause with last menses >1 year ago; or
- Underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
- Female subjects of childbearing potential and male subjects with a sexual partner of childbearing potential must agree to use a highly effective method of contraception and the lactation requirements as described in Sections 5.4.1 and 5.4.2.
- Subjects or their legal representatives must be able to read, understand, and provide informed consent to participate in the trial.
- Willing and capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol
Who cannot join
- PTLD following liquid transplantation
- CNS involvement
- Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression
- Human immunodeficiency virus (HIV) infection
- Major surgery within 4 weeks prior to enrolment
- History of bleeding diathesis (e.g., von Willebrand's disease), hemophilia, or active bleeding.
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- Subjects with chronic liver disease with hepatic impairment Child-Pugh class C
- Pregnant or lactating or intending to become pregnant during the study
- Active autoimmune disease which, in the opinion of the investigator, may negatively impact subject safety or interfere with study participation.
- The diagnosis of another malignancy which, in the opinion of the investigator, is likely to negatively impact subject safety or interfere with study participation.
- Significant medical diseases or conditions including those requiring substantial changes in concomitant medications, as assessed by the investigator, that would substantially increase the risk-to-benefit ratio of participating in the study. This includes, but is not limited to the following conditions:
- Cardiovascular disorders:
- Congestive heart failure New York Heart Association Class III or IV, unstable angina pectoris, serious cardiac arrhythmias.
- Myocardial infarction (MI) within 6 months before the first dose.
- QTc prolongation defined as a QTcF > 480 ms.
- Congenital long QT syndrome or a corrected QT measure (QTc) interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block).
- Grade 2 or higher edema (peripheral, pleural or ascites)
- Grade 1 or higher pericardial effusion
- Severe pulmonary disease
- Uncontrolled diabetes mellitus
- Severely immunocompromised state
- Any other condition that would, in the Investigator's judgment, contraindicate the subject's participation in the clinical study due to safety concerns or compliance with clinical study procedures.
- Active systemic bacterial, viral, fungal, or other infection requiring systemic treatment at time of screening
- Subjects with evidence of active hepatitis B infection, based on positive surface antigen or Hepatitis B DNA PCR are excluded. Subjects who are Hepatitis B core antibody positive must take prophylaxis with entecavir or equivalent and be willing to undergo monthly Hepatitis B DNA PCR testing
- Active hepatitis C infection
- Grade 2 or higher rash
- Clinically significant fluid accumulation in the third space
- Subjects taking prohibited medications as described in Section 6.8.1. A washout period of prohibited medications for a period of at least five half-lives or as clinically indicated should occur before the start of treatment.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Huntsman Cancer Institute at University of Utah
Salt Lake City, Utah, 84112
Rachel Kingsford, 801-585-0115, rachel.kingsford@hci.utah.edu
About this study
Official title: A Phase 1/2 Study of Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
The purpose of phase I of this clinical trial is to learn the recommended dose of the drugs loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).
The purpose of phase II of this clinical trial is to learn if the drugs loncastuximab tesirine and rituximab are effective in participants with post-transplant lymphoproliferative disorders (PTLD).
- Being tested
- Loncastuximab tesirine, Rituximab or rituximab biosimilar
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loncastuximab tesirineDrug
Lonca will be administered by IV at 75µg/kg every 3 weeks (DL1).
Rituximab or rituximab biosimilarDrug
Also called RITUXAN, Truxima, Ruxience, Riabni
Rituximab or rituximab biosimilar will be administered by IV at 375 mg/m2 on Day 1 of every cycle. Lonca will be administered first, followed by rituximab (with a 30 min wait time between the two agents)
| Study group | Role | What they receive |
|---|---|---|
| Dose Level 1 (starting dose): SD or PD | Experimental | Dose Level 1:
* Loncastuximab tesirine: 0.075 mg/kg IV every 3 weeks
* Rituximab: 375 mg/m2 IV
This arm included participants who had SD (Stable Disease) or PD (Progressive Disease) after the first 6 weeks of treatment.
Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they do not achieve a response, they will come off the study but will be monitored for survival. Receives: Drug: Loncastuximab tesirine; Drug: Rituximab or rituximab biosimilar |
| Dose Level 1 (starting dose): PR | Experimental | Dose Level 1:
* Loncastuximab tesirine: 0.075 mg/kg IV every 3 weeks
* Rituximab: 375 mg/m2 IV
This arm included participants who had a Partial Response (PR) after the first 6 weeks of treatment.
Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they achieve PR, they will have the option to receive either rituximab consolidation or R-CHOP (at the physician's discretion). Receives: Drug: Loncastuximab tesirine; Drug: Rituximab or rituximab biosimilar |
| Dose Level 1 (starting dose): CR | Experimental | Dose Level 1:
* Loncastuximab tesirine: 0.075 mg/kg IV every 3 weeks
* Rituximab: 375 mg/m2 IV
This arm included participants who had a Complete Response (CR) after the first 6 weeks of treatment.
Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they achieve a CR after 4 cycles of Lonca-R, they will receive rituximab consolidation (SOC). Receives: Drug: Loncastuximab tesirine; Drug: Rituximab or rituximab biosimilar |
| Dose Level 2: SD or PD | Experimental | Dose Level 2:
* Loncastuximab tesirine: 0.15 mg/kg IV every 3 weeks for the first 2 cycles, then 0.075 mg/kg starting C3
* Rituximab: 375 mg/m2 IV
This arm included participants who had SD (Stable Disease) or PD (Progressive Disease) after the first 6 weeks of treatment.
Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they do not achieve a response, they will come off the study but will be monitored for survival. Receives: Drug: Loncastuximab tesirine; Drug: Rituximab or rituximab biosimilar |
| Dose Level 2: PR | Experimental | Dose Level 2:
* Loncastuximab tesirine: 0.15 mg/kg IV every 3 weeks for the first 2 cycles, then 0.075 mg/kg starting C3
* Rituximab: 375 mg/m2 IV
This arm included participants who had a Partial Response (PR) after the first 6 weeks of treatment.
Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they achieve PR, they will have the option to receive either rituximab consolidation or R-CHOP (at the physician's discretion). Receives: Drug: Loncastuximab tesirine; Drug: Rituximab or rituximab biosimilar |
| Dose Level 2: CR | Experimental | Dose Level 2:
* Loncastuximab tesirine: 0.15 mg/kg IV every 3 weeks for the first 2 cycles, then 0.075 mg/kg starting C3
* Rituximab: 375 mg/m2 IV
This arm included participants who had a Complete Response (CR) after the first 6 weeks of treatment.
Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they achieve a CR after 4 cycles of Lonca-R, they will receive rituximab consolidation (SOC). Receives: Drug: Loncastuximab tesirine; Drug: Rituximab or rituximab biosimilar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase I: Define Maximum Tolerated Dose (MTD) based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period.
To assess the Recommended Phase 2 Dose (RP2D) of loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).
Measured: 4 years
Phase II: The complete response (CR) rate after 4 cycles of lonca-R per Lugano 2014 criteria1.
To assess the efficacy of the combination of lonca-R based on CR rate after 4 cycles.
Measured: 4 years
Secondary outcomes (5)
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 6.0), seriousness, duration, and relationship to study treatment.
To assess the safety and tolerability of lonca-R in subjects with B-cell PTLD.
Measured: 4 years
The overall response rate (ORR) after 4 cycles of lonca-R.
To determine ORR after 4 cycles of lonca-R in subjects with B-cell PTLD.
Measured: 4 years
The best complete response (CR) rate is defined as CR at the completion of 4 cycles of lonca-R or 4 cycles of lonca-R and 4 cycles of consolidation of rituximab monotherapy (every 3 weeks) in subjects with B-cell PTLD.
To determine the best CR rate in subjects with B-cell PTLD.
Measured: 4 years
Median and two year progression-free survival (PFS). PFS will be as defined as the time from study drug initiation to the time of documented disease progression (as assessed by Lugano Criteria), or death from any cause.
To assess PFS.
Measured: 4 years
Median and two year overall survival (OS). OS is defined as the time from initiation of treatment until death from any cause.
To assess OS.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-transplant Lymphoproliferative DisorderStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Responsible party
- Sponsor
- Investigators
- Narendranath Epperla, MD, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07573436
- Sponsor's protocol ID
- HCI198713
- Acronym
- PLUTO
- Status last verified
- Oct 2026
- First submitted
- 30 Apr 2026
- Last updated
- 9 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1/2 Study of Loncastuximab Tesirine and Rituximab as First-line Therapy in Patients With Post-transplant Lymphoproliferative Disorder (PLUTO)
- ClinicalTrials.gov ID
- NCT07573436
- Acronym / sponsor ID
- PLUTO / HCI198713
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- ADC Therapeutics S.A.
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jun 2031 (estimated)
- First posted
- 7 May 2026 (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 phase I of this clinical trial is to learn the recommended dose of the drugs loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).
The purpose of phase II of this clinical trial is to learn if the drugs loncastuximab tesirine and rituximab are effective in participants with post-transplant lymphoproliferative disorders (PTLD).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Dose Level 1 (starting dose): SD or PD | Experimental | Drug: Loncastuximab tesirine, Drug: Rituximab or rituximab biosimilarDose Level 1: * Loncastuximab tesirine: 0.075 mg/kg IV every 3 weeks * Rituximab: 375 mg/m2 IV This arm included participants who had SD (Stable Disease) or PD (Progressive Disease) after the first 6 weeks of treatment. Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they do not achieve a response, they will come off the study but will be monitored for survival. |
| Dose Level 1 (starting dose): PR | Experimental | Drug: Loncastuximab tesirine, Drug: Rituximab or rituximab biosimilarDose Level 1: * Loncastuximab tesirine: 0.075 mg/kg IV every 3 weeks * Rituximab: 375 mg/m2 IV This arm included participants who had a Partial Response (PR) after the first 6 weeks of treatment. Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they achieve PR, they will have the option to receive either rituximab consolidation or R-CHOP (at the physician's discretion). |
| Dose Level 1 (starting dose): CR | Experimental | Drug: Loncastuximab tesirine, Drug: Rituximab or rituximab biosimilarDose Level 1: * Loncastuximab tesirine: 0.075 mg/kg IV every 3 weeks * Rituximab: 375 mg/m2 IV This arm included participants who had a Complete Response (CR) after the first 6 weeks of treatment. Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they achieve a CR after 4 cycles of Lonca-R, they will receive rituximab consolidation (SOC). |
| Dose Level 2: SD or PD | Experimental | Drug: Loncastuximab tesirine, Drug: Rituximab or rituximab biosimilarDose Level 2: * Loncastuximab tesirine: 0.15 mg/kg IV every 3 weeks for the first 2 cycles, then 0.075 mg/kg starting C3 * Rituximab: 375 mg/m2 IV This arm included participants who had SD (Stable Disease) or PD (Progressive Disease) after the first 6 weeks of treatment. Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they do not achieve a response, they will come off the study but will be monitored for survival. |
| Dose Level 2: PR | Experimental | Drug: Loncastuximab tesirine, Drug: Rituximab or rituximab biosimilarDose Level 2: * Loncastuximab tesirine: 0.15 mg/kg IV every 3 weeks for the first 2 cycles, then 0.075 mg/kg starting C3 * Rituximab: 375 mg/m2 IV This arm included participants who had a Partial Response (PR) after the first 6 weeks of treatment. Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they achieve PR, they will have the option to receive either rituximab consolidation or R-CHOP (at the physician's discretion). |
| Dose Level 2: CR | Experimental | Drug: Loncastuximab tesirine, Drug: Rituximab or rituximab biosimilarDose Level 2: * Loncastuximab tesirine: 0.15 mg/kg IV every 3 weeks for the first 2 cycles, then 0.075 mg/kg starting C3 * Rituximab: 375 mg/m2 IV This arm included participants who had a Complete Response (CR) after the first 6 weeks of treatment. Lonca-R will be administered for 4 cycles with response assessment at 6 weeks (+/- 1 week) following the last Lonca-R treatment. If they achieve a CR after 4 cycles of Lonca-R, they will receive rituximab consolidation (SOC). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (28 listed)
- Subject aged ≥ 18 years.
- Histologically confirmed B-cell PTLD (monomorphic and polymorphic) following solid organ transplantation; with or without EBV association.
- --Note: Subjects with classic Hodgkin-like PTLD are excluded.
- Measurable disease as defined by the 2014 Lugano Classification as assessed by positron-emission tomography (PET)- computed tomography (CT) or by CT or magnetic resonance imaging (MRI) if the tumor is not fluorodeoxyglucose (FDG)-avid on screening
- ECOG Performance Status ≤ 2.
Key exclusion criteria (28 listed)
- PTLD following liquid transplantation
- CNS involvement
- Prior treatment for PTLD with the exception of radiation, antivirals, steroids and reduced immunosuppression
- Human immunodeficiency virus (HIV) infection
- Major surgery within 4 weeks prior to enrolment
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 |
|---|---|---|
| Loncastuximab tesirineLonca will be administered by IV at 75µg/kg every 3 weeks (DL1). | Drug | Dose Level 1 (starting dose): CR, Dose Level 1 (starting dose): PR, Dose Level 1 (starting dose): SD or PD, Dose Level 2: CR, Dose Level 2: PR, Dose Level 2: SD or PD |
| Rituximab or rituximab biosimilarAlso: RITUXAN, Truxima, Ruxience, RiabniRituximab or rituximab biosimilar will be administered by IV at 375 mg/m2 on Day 1 of every cycle. Lonca will be administered first, followed by rituximab (with a 30 min wait time between the two agents) | Drug | Dose Level 1 (starting dose): CR, Dose Level 1 (starting dose): PR, Dose Level 1 (starting dose): SD or PD, Dose Level 2: CR, Dose Level 2: PR, Dose Level 2: SD or PD |
Primary outcome
Phase I: Define Maximum Tolerated Dose (MTD) based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period.
Time frame: 4 years
To assess the Recommended Phase 2 Dose (RP2D) of loncastuximab tesirine and rituximab in participants with post-transplant lymphoproliferative disorders (PTLD).
Phase II: The complete response (CR) rate after 4 cycles of lonca-R per Lugano 2014 criteria1.
Time frame: 4 years
To assess the efficacy of the combination of lonca-R based on CR rate after 4 cycles.
5 secondary outcomes
The frequency of adverse events (AEs) and serious adverse events (SAEs) characterized by type, severity (as defined by the NIH CTCAE, version 6.0), seriousness, duration, and relationship to study treatment.
Time frame: 4 years
The overall response rate (ORR) after 4 cycles of lonca-R.
Time frame: 4 years
The best complete response (CR) rate is defined as CR at the completion of 4 cycles of lonca-R or 4 cycles of lonca-R and 4 cycles of consolidation of rituximab monotherapy (every 3 weeks) in subjects with B-cell PTLD.
Time frame: 4 years
Median and two year progression-free survival (PFS). PFS will be as defined as the time from study drug initiation to the time of documented disease progression (as assessed by Lugano Criteria), or death from any cause.
Time frame: 4 years
Median and two year overall survival (OS). OS is defined as the time from initiation of treatment until death from any cause.
Time frame: 4 years
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 9 Oct 2026.
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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.
Narendranath Epperla, MD principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Loncastuximab tesirine and Rituximab or rituximab biosimilar in people with Post-transplant Lymphoproliferative Disorder, run by University of Utah 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 28 inclusion and 28 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: opening soon, as of the sponsor's last update on 9 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 combined 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.
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?
Contact Rachel Kingsford (801-585-0115, rachel.kingsford@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase I: Define Maximum Tolerated Dose (MTD) based on the rate of dose-limiting toxicities (DLTs) during the DLT evaluation period. (time frame: 4 years). The study lists 2 primary outcomes in all. 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 9 Oct 2026.