DLBCL - Diffuse Large B Cell LymphomaPhase 1ODINNCT05950802
Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving Cell Therapy With Yescarta
A Phase 1 study testing Cyclophosphamide and TLI in people with DLBCL - Diffuse Large B Cell Lymphoma, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
This is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- DLBCL - Diffuse Large B Cell Lymphoma
- What is being tested?
- Cyclophosphamide and TLI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 14 Jul 2023to Sep 2027
- 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
- Age ≥ 18 years at the time of informed consent
- Life expectancy ≥ 12 weeks
- Biopsy-proven and histologically confirmed R/R large B cell lymphoma, including R/R DLBCL, transformation from FL, and R/R PMBCL.
- Radiographically documented measurable disease as per Lugano response criteria (i.e. LDi > 1.5 cm that is FDG avid).
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent
- Eligible for standard of care CAR T cell therapy, specifically, relapsed or refractory large B cell lymphoma after two or more lines of systemic therapy, and subjects must have received adequate first-line therapy including at a minimum:
Show all 18Show fewer
- Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and
- An anthracycline containing chemotherapy regimen
- Patient does not have active CNS disease
- Patient is sufficiently stable to facilitate planned CAR T-cell therapy (e.g. not rapidly progressing on temporizing therapy, no significant compromise of vital organ functions (intubation, dialysis, requiring ICU/vasopressor support)) and has good performance status
- ECOG performance status 0 or 1 at enrollment
- Patient has not received prior adoptive T-cell immunotherapy
- Patient is not HIV positive
- Patient did not receive prior allogeneic stem cell transplant
- Adequate bone marrow, renal, hepatic, pulmonary and cardiac function
- Females of childbearing potential must have a negative serum or urine pregnancy test (females who have undergone surgical sterilization or who have been postmenopausal for at least 2 years are not considered to be of childbearing potential)
- Sexually active males who accept to use a condom during intercourse during treatment and for 6 months after treatment as they should not father a child in this period. A condom is required to be used also by vasectomized men (as well as during intercourse with a male partner) in order to prevent delivery of the drug via seminal fluid
- Must have an apheresis product of non-mobilized cells accepted for manufacturing.
Who cannot join
- Persisting disease bulk (defined as ≥10 cm) on restaging imaging following bridging therapy.
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
- History of Richter's transformation of CLL
- History of allogeneic stem cell transplant
- Received < 2 lines of therapy for large B cell lymphoma
- Prior CD19 targeted therapy
Show all 35Show fewer
- Subject has received or undergone the following:
- o Therapeutic doses of corticosteroids (defined as >20 mg/day prednisone or equivalent) within 7 days prior to leukapheresis.
- Physiologic steroid replacement, topical, and inhaled steroids are permitted.
- Cytotoxic chemotherapeutic agents that are not considered lymphotoxic, and intrathecal (IT) chemotherapy must be stopped ≥ 7 days prior to leukapheresis.
- Lymphotoxic chemotherapeutic agents (eg, cyclophosphamide > 300 mg/m2, ifosfamide, bendamustine) 4 weeks prior to leukapheresis.
- Experimental agents within 4 weeks prior to signing the ICF, unless no response or PD is documented on the experimental therapy and at least 5 half-lives have elapsed prior to leukapheresis.
- Ibrutinib, lenalidomide and PI3K inhibitor within 5 half-lives prior to leukapheresis
- Immunosuppressive therapies within 4 weeks prior to leukapheresis (eg, calcineurin inhibitors, methotrexate or other chemotherapeutics, mycophenolate, rapamycin thalidomide, immunosuppressive antibodies such as anti-tumor necrosis factor [TNF], anti-IL6, or anti- IL6R)
- Radiation within 6 weeks of leukapheresis. Subject must have progressive disease in irradiated lesions or have additional nonirradiated, PET-positive lesions to be eligible. Radiation to a single lesion, if additional non-irradiated PET-positive lesions are present, is allowed up to 2 weeks prior to leukapheresis (discuss with sponsor).
- Treatment with systemic immunostimulatory agents (including but not limited to interferon and IL-2) within 6 weeks or 5 half-lives of the drug, whichever is shorter, prior to the infusion of axicabtagene ciloleucel
- Prior chimeric antigen receptor therapy or other genetically modified T-cell therapy
- Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous (IV) antimicrobials for management. Simple urinary tract infection (UTI) and uncomplicated bacterial pharyngitis are permitted if responding to active treatment.
- Known history of infection with human immunodeficiency virus (HIV) or hepatitis B (HBsAg positive) or hepatitis C virus (anti-HCV positive). If there is a positive history of treated hepatitis B or hepatitis C, the viral load must be undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
- Active tuberculosis
- Presence of any indwelling line or drain (eg, percutaneous nephrostomy tube, indwelling Foley catheter, biliary drain, or pleural/peritoneal/pericardial catheter). Dedicated central venous access catheters such as a Port-a-Cath or Hickman catheter are permitted
- Subjects with detectable cerebrospinal fluid malignant cells or known CNS involvement; a history of prior treated CNS lymphoma which is not active at the time of relapse is permitted
- History or presence of significant non-malignant CNS disorder such as seizure disorder, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with CNS involvement
- Subjects with cardiac atrial or cardiac ventricular lymphoma involvement
- History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, or other clinically significant cardiac disease within 12 months of enrollment
- Requirement for urgent therapy due to tumor mass effects such as bowel obstruction or blood vessel compression
- History of autoimmune disease, requiring systemic immunosuppression and/or systemic disease modifying agents within the last 2 years.
- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis per chest computed tomography (CT) scan at screening. History of radiation pneumonitis in the radiation field (fibrosis) is allowed.
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months of enrollment
- Any medical condition likely to interfere with assessment of safety or efficacy of study treatment
- History of severe immediate hypersensitivity reaction to tocilizumab or any of the agents used in this study
- Treatment with a live, attenuated vaccine within 6 weeks prior to initiation of study treatment, or anticipation of need for such a vaccine during the course of the study
- Women of childbearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of chemotherapy on the fetus or infant.
- Subjects of either sex who are not willing to practice birth control from the time of consent and at least 6 months after axicabtagene ciloleucel infusion
- In the investigators judgment, the subject is unlikely to complete all protocol- required study visits or procedures, including followup visits, or comply with the study requirements for participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario
John Kuruvilla, 4169462821, LymphomaClinicalTrials@uhn.ca
About this study
Official title: Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving CAR T Cell Therapy With Yescarta/AxicabtageNeciloleucel (ODIN)
This is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care CAR T cell therapy.
Read the detailed description
Patients will be enrolled in two stages: the dose escalation stage to assess the safety and tolerability of a modified LD regimen, and once the maximum tolerated dose (MTD) is determined, a cohort expansion phase to further characterize the toxicity and efficacy profile and determine the recommended phase 2 dose (RP2D). The study will enroll approximately 18-24 patients in the dose escalation stage (Part 1), and approximately 20 further patients at cohort expansion (Part 2). There will be four dose escalation cohorts, in two study arms. There are two dosing cohorts in each study arm. Patients in Arm 1 will receive the ZUMA-1 chemotherapy LD regimen with or without TLI, and in Arm 2, an intermediate dose of Cy with a fixed dose of Flu, with or without TLI, will be given.
The cohorts in Arm 1 will enroll concurrently, and enrollment into Arm 2 will begin after Arm 1 has enrolled all patients and data review by the Trial Steering Committee (TSC).
For accrual into Cohort 2, Arm 1, there will be a 15-day staggered enrollment for the first 2 patients. Staggered enrollment with another 15-day delay may be considered for enrollment into Cohorts 3 and 4, Arm 2, after review by the TSC. Following completion of accrual to Arm 1, a 30 day dose-limiting toxicity (DLT) window will be observed, prior to review by the TSC and commencement of enrollment into Arm 2.
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Being tested
- Cyclophosphamide, TLI
- Medical subject headings
- Dendritic Cell Sarcoma, Interdigitating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called cytoxin, neosar
Higher dose than traditional conditioning chemo
TLIRadiation
radiation given with conditioning chemo
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide and fludarabine, standard dose | No intervention | Fludarabine 30mg/m2 Cyclophosphamide 500mg/m2 Days -4, -3, -2 |
| Cyclophosphamide and fludarabine, standard dose with radiation | Experimental | Fludarabine 30mg/m2 Cyclophosphamide 500mg/m2 Days -6, -5, -4, and 2 Gy in 2 Fractions Days -3, -2 Receives: Drug: Cyclophosphamide; Radiation: TLI |
| Cyclophosphamide (intermediate dose) and fludarabine | Experimental | Fludarabine 30mg/m2 Cyclophosphamide 750mg/m2 Days -4, -3, -2 Receives: Drug: Cyclophosphamide |
| Cyclophosphamide (intermediate dose) and fludarabine with radiation | Experimental | Fludarabine 30mg/m2 Cyclophosphamide 750mg/m2 Days -6, -5, -4, and 2 Gy in 2 Fractions Days -3, -2 Receives: Drug: Cyclophosphamide; Radiation: TLI |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of chemo rads as conditioning chemo
To assess the safety and tolerability of a combination chemo-radiation lymphodepletion (LD) regimen (Fludarabine (Flu)/Cyclophosphamide (Cy) + total lymphoid irradiation (TLI ) in patients receiving standard of care CAR T cell therapy for relapsed/refractory diffuse large B cell lymphoma (R/R DLBCL), by establishing the maximum tolerated doses (MTD) of standard (ZUMA-1) dose Flu/Cy + TLI, and of intermediate dose iCy/Flu +/- TLI, and the dose limiting toxicities (DLT) of standard dose Flu/Cy + TLI, and of intermediate dose iCy/Flu +/- TLI
Measured: baseline through Day 30
Secondary outcomes (3)
Overall response rate
The overall response rate is the proportion of patients with either a CR or PR while on study. All patients who do not meet the criteria for objective response by the analysis data cutoff date will be considered non-responders. This will be measured by CT/PET
Measured: baseline through day 365
Complete response
To assess the efficacy (complete response (CR) rate at 12 months) of a combination chemo-radiation LD regimen (standard dose Flu/Cy + TLI) in patients receiving CAR T cell therapy for R/R DLBCL. To assess the efficacy of an intermediate dose iCy/Flu +/- TLI LD regimen in patients receiving CAR T cell therapy for R/R DLBCL. All CR and PR responses may be reviewed by an expert(s) / independent radiologist as required by simultaneous review of patient files and radiologic images
Measured: baseline through day 365
Progression free survival
To assess the efficacy (progression free survival (PFS) at 12 months) of a combination chemo-radiation LD regimen (standard dose Flu/Cy + TLI) in patients receiving CAR T cell therapy for R/R DLBCL. To assess the efficacy of an intermediate dose iCy/Flu +/- TLI LD regimen in patients receiving CAR T cell therapy for R/R DLBCL. Progression free survival (PFS) is defined as the duration of time from start of treatment to time of progression or death, whichever occurs first.
Measured: baseline through day 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start14 Jul 2023
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DLBCL - Diffuse Large B Cell LymphomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Model description
- Patients will be enrolled in two stages: the dose escalation stage to assess the safety and tolerability of a modified LD regimen, and once the MTD is determined, a cohort expansion phase to further characterize the toxicity and efficacy profile and determine the RP2D. The study will enroll approximately 18-24 patients in the dose escalation stage (Part 1), and approximately 20 further patients at cohort expansion (Part 2)
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950802
- Sponsor's protocol ID
- OZM-124
- Acronym
- ODIN
- Status last verified
- Dec 2025
- First submitted
- 29 Jun 2023
- Last updated
- 8 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing lymphoDepletion to Improve Outcomes In Patients Receiving CAR T Cell Therapy With Yescarta/AxicabtageNeciloleucel (ODIN)
- ClinicalTrials.gov ID
- NCT05950802
- Acronym / sponsor ID
- ODIN / OZM-124
- Conditions
- DLBCL - Diffuse Large B Cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 14 Jul 2023 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 18 Jul 2023 (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 is a Phase 1b study of participants with Diffuse Large B Cell Lymphoma (DLBCL). The purpose of this study is to identify an optimized lymphodenpletion (LD) regimen by evaluating standard and intermediate doses of Fludarabine (Flu) / Cyclophosphamide (Cy) with or without a fixed dose of total lymphoid irradiation (TLI) in the setting of standard of care CAR T cell therapy.
Detailed description
Patients will be enrolled in two stages: the dose escalation stage to assess the safety and tolerability of a modified LD regimen, and once the maximum tolerated dose (MTD) is determined, a cohort expansion phase to further characterize the toxicity and efficacy profile and determine the recommended phase 2 dose (RP2D). The study will enroll approximately 18-24 patients in the dose escalation stage (Part 1), and approximately 20 further patients at cohort expansion (Part 2). There will be four dose escalation cohorts, in two study arms. There are two dosing cohorts in each study arm. Patients in Arm 1 will receive the ZUMA-1 chemotherapy LD regimen with or without TLI, and in Arm 2, an intermediate dose of Cy with a fixed dose of Flu, with or without TLI, will be given.
The cohorts in Arm 1 will enroll concurrently, and enrollment into Arm 2 will begin after Arm 1 has enrolled all patients and data review by the Trial Steering Committee (TSC).
For accrual into Cohort 2, Arm 1, there will be a 15-day staggered enrollment for the first 2 patients. Staggered enrollment with another 15-day delay may be considered for enrollment into Cohorts 3 and 4, Arm 2, after review by the TSC. Following completion of accrual to Arm 1, a 30 day dose-limiting toxicity (DLT) window will be observed, prior to review by the TSC and commencement of enrollment into Arm 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Patients will be enrolled in two stages: the dose escalation stage to assess the safety and tolerability of a modified LD regimen, and once the MTD is determined, a cohort expansion phase to further characterize the toxicity and efficacy profile and determine the RP2D. The study will enroll approximately 18-24 patients in the dose escalation stage (Part 1), and approximately 20 further patients at cohort expansion (Part 2)
| Arm | Type | Receives |
|---|---|---|
| Cyclophosphamide and fludarabine, standard dose | No intervention | –Fludarabine 30mg/m2 Cyclophosphamide 500mg/m2 Days -4, -3, -2 |
| Cyclophosphamide and fludarabine, standard dose with radiation | Experimental | Drug: Cyclophosphamide, Radiation: TLIFludarabine 30mg/m2 Cyclophosphamide 500mg/m2 Days -6, -5, -4, and 2 Gy in 2 Fractions Days -3, -2 |
| Cyclophosphamide (intermediate dose) and fludarabine | Experimental | Drug: CyclophosphamideFludarabine 30mg/m2 Cyclophosphamide 750mg/m2 Days -4, -3, -2 |
| Cyclophosphamide (intermediate dose) and fludarabine with radiation | Experimental | Drug: Cyclophosphamide, Radiation: TLIFludarabine 30mg/m2 Cyclophosphamide 750mg/m2 Days -6, -5, -4, and 2 Gy in 2 Fractions Days -3, -2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Age ≥ 18 years at the time of informed consent
- Life expectancy ≥ 12 weeks
- Biopsy-proven and histologically confirmed R/R large B cell lymphoma, including R/R DLBCL, transformation from FL, and R/R PMBCL.
- Radiographically documented measurable disease as per Lugano response criteria (i.e. LDi > 1.5 cm that is FDG avid).
- At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic cancer therapy at the time the subject provides consent
Key exclusion criteria (35 listed)
- Persisting disease bulk (defined as ≥10 cm) on restaging imaging following bridging therapy.
- History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (e.g. cervix, bladder, breast) unless disease free for at least 3 years
- History of Richter's transformation of CLL
- History of allogeneic stem cell transplant
- Received < 2 lines of therapy for large B cell lymphoma
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 |
|---|---|---|
| CyclophosphamideAlso: cytoxin, neosarHigher dose than traditional conditioning chemo | Drug | Cyclophosphamide (intermediate dose) and fludarabine, Cyclophosphamide (intermediate dose) and fludarabine with radiation, Cyclophosphamide and fludarabine, standard dose with radiation |
| TLIradiation given with conditioning chemo | Radiation | Cyclophosphamide (intermediate dose) and fludarabine with radiation, Cyclophosphamide and fludarabine, standard dose with radiation |
Primary outcome
safety and tolerability of chemo rads as conditioning chemo
Time frame: baseline through Day 30
To assess the safety and tolerability of a combination chemo-radiation lymphodepletion (LD) regimen (Fludarabine (Flu)/Cyclophosphamide (Cy) + total lymphoid irradiation (TLI ) in patients receiving standard of care CAR T cell therapy for relapsed/refractory diffuse large B cell lymphoma (R/R DLBCL), by establishing the maximum tolerated doses (MTD) of standard (ZUMA-1) dose Flu/Cy + TLI, and of intermediate dose iCy/Flu +/- TLI, and the dose limiting toxicities (DLT) of standard dose Flu/Cy + TLI, and of intermediate dose iCy/Flu +/- TLI
3 secondary outcomes
Overall response rate
Time frame: baseline through day 365
Complete response
Time frame: baseline through day 365
Progression free survival
Time frame: baseline through day 365
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 8 Dec 2025.
Related trials for DLBCL - Diffuse Large B Cell Lymphoma
RecruitingObservational study
An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma
Diffuse Large B-Cell Lymphoma
RecruitingPhase 1
AMC 120, Glofitamab Plus Chemoimmunotherapy in Newly Diagnosed HIV-Associated Large B-Cell Lymphoma (The "Glofit-RCHOP Study")
AIDS-Related Diffuse Large B-cell Lymphoma, Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Not yet recruitingPhase 2/3
A Clinical Trial of MK-1045 With Zilovertamab Vedotin in Participants With Diffuse Large B-cell Lymphoma (MK-1045-010)
Lymphoma, Large B-Cell, Diffuse, Diffuse Large B-Cell Lymphoma
Active, not recruitingPhase 1
A Rollover Study of CC-122
Non-Hodgkin 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cyclophosphamide and TLI in people with DLBCL - Diffuse Large B Cell Lymphoma, run by University Health Network, Toronto at 1 site in Canada.
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 18 inclusion and 35 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 8 Dec 2025. 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 Canada. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safety and tolerability of chemo rads as conditioning chemo (time frame: baseline through Day 30). 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 8 Dec 2025.