Lymphoma, Large B-Cell, DiffusePhase 1LOKINCT06003179
Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah
A Phase 1 study testing Cyclophosphamide, TLI and Fludarabine in people with Lymphoma, Large B-Cell, Diffuse, 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 lymphodepletion (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
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Cyclophosphamide, TLI and Fludarabine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 5 Apr 2024to Nov 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years at the time of informed consent
- Life expectancy ≥ 12 weeks
- Biopsy-proven and histologically confirmed relapse/refractory (R/R) large B cell lymphoma, including Primary mediastinal B-cell lymphoma (PMBCL), R/R DLBCL and transformation from Follicular lymphoma (FL).
- Radiographically documented measurable disease as per Lugano response criteria (i.e. longest transverse diameter of a lesion (LDi) > 1.5 cm that is [18F] fluorodeoxyglucose (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:
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- 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 Intensive care unit (ICU)/vasopressor support)) and has good performance status
- Patient does not have active central nervous system (CNS) disease
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at enrollment
- Patient has not received prior adoptive T-cell immunotherapy
- Patient is not human immunodeficiency virus (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 12 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 chronic lymphocytic leukemia (CLL)
- History of allogeneic stem cell transplant
- Received < 2 lines of therapy for large B cell lymphoma
- Prior CD19 targeted therapy
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- Subject has received or undergone the protocol defined treatments/therapies
- 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
- 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 tisagenlecleucel infusion
- In the investigators judgment, the subject is unlikely to complete all protocol-required study visits or procedures, including follow-up visits, or comply with the study requirements for participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Anti Cluster of Differentiation Antigen 19 (Anti-CD19) Chimeric Antigen Receptor T (CAR T) Cell Therapy With Kymriah/tIsagenlecleucel (LOKI)
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 lymphodepletion (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 chimeric antigen receptor T (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 20-40 patients in the dose escalation stage (Part 1), and approximately 20 further patients at cohort expansion (Part 2). There will be six dose escalation cohorts, in three study arms. There are two dosing cohorts in each study arm. Patients in Arm 1 will receive the JULIET chemotherapy LD regimen with or without TLI, and in Arms 2 and 3, intermediate doses 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). Similarly, enrollment into Arm 3 will only commence once Arm 2 has accrued and relevant safety data has been reviewed.
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 relevant cohorts in Arms 2 and 3, 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 patient enrollment into Arm 2. The same procedure and DLT window will be followed prior to patient enrollment into Arm 3.
One DLT window will be observed during this study: 30 days post infusion of tisagenlecleucel.
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- Cyclophosphamide, TLI, Fludarabine
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CyclophosphamideDrug
Also called Cytoxan, neosar
Conditioning chemo at different doses
TLIRadiation
radiation given with conditioning chemo
FludarabineDrug
Fludarabine given as part of standard treatment
| Study group | Role | What they receive |
|---|---|---|
| Cyclophosphamide and fludarabine, standard dose | Active comparator | Fludarabine 25mg/m2 Cyclophosphamide 250mg/m2 Days -4, -3, -2 Receives: Drug: Cyclophosphamide; Drug: Fludarabine |
| Cyclophosphamide and fludarabine, standard dose with radiation | Experimental | Fludarabine 25mg/m2 Cyclophosphamide 250mg/m2 Days -6, -5, -4 2 Gy in 2 Fractions Days -3, -2 Receives: Radiation: TLI; Drug: Fludarabine |
| Cyclophosphamide (intermediate dose) and fludarabine | Experimental | Fludarabine 25mg/m2 Cyclophosphamide 500mg/m2 Days -4, -3, -2 Receives: Drug: Cyclophosphamide; Drug: Fludarabine |
| Cyclophosphamide (intermediate dose) and fludarabine with radiation | Experimental | Fludarabine 25mg/m2 Cyclophosphamide 500mg/m2 Days -6, -5, -4 2 Gy in 2 Fractions Days -3, -2 Receives: Drug: Cyclophosphamide; Radiation: TLI; Drug: Fludarabine |
| Cyclophosphamide (high dose) and fludarabine | Experimental | Fludarabine 25mg/m2 Cyclophosphamide 750mg/m2 Days -4, -3, -2 Receives: Drug: Cyclophosphamide; Drug: Fludarabine |
| Cyclophosphamide (high dose) and fludarabine with radiation | Experimental | Fludarabine 25mg/m2 Cyclophosphamide 750mg/m2 Days -6, -5, -4 2 Gy in 2 Fractions Days -3, -2 Receives: Drug: Cyclophosphamide; Radiation: TLI; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum tolerated dose (MTD) and dose limiting toxicity (DLT) for chemo plus radiation as 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 (JULIET) 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 end of study completion, approximately 2 years
Secondary outcomes (6)
overall response rate (ORR) at 12 months of chemo rads
To assess the ORR 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.
Measured: baseline to 12 months post CAR-T
complete response (CR) rate at 12 months of chemo rads
To assess the CR rate of a combination chemo-radiation LD regimen (standard dose Flu/Cy + TLI) in patients receiving CAR T cell therapy for R/R DLBCL.
Measured: baseline to 12 months post CAR-T
progression free survival (PFS) at 12 months of chemo rads
To assess the PFS 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.
Measured: baseline to 12 months post CAR-T
ORR at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
To assess the ORR at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen in patients receiving CAR T cell therapy for R/R DLBCL
Measured: baseline to 12 months post CAR-T
CR rate at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
To assess the CR rate at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen in patients receiving CAR T cell therapy for R/R DLBCL
Measured: baseline to 12 months post CAR-T
PFS at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
To assess the PFS rate at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen in patients receiving CAR T cell therapy for R/R DLBCL
Measured: baseline to 12 months post CAR-T
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start5 Apr 2024
- Primary completionNov 2026 (estimated)
- Study completionNov 2028 (estimated)
Why it stopped: recruitment challenges and sites who initially expressed interest declined.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies 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 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 20-40 patients in the dose escalation stage (Part 1), and approximately 20 further patients at cohort expansion (Part 2).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John G Kuruvilla, Principal investigator, Princess Margaret Cancer Centre - University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06003179
- Sponsor's protocol ID
- OZM-123
- Acronym
- LOKI
- Status last verified
- Nov 2024
- First submitted
- 10 Jul 2023
- Last updated
- 12 Nov 2024
- 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 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Anti Cluster of Differentiation Antigen 19 (Anti-CD19) Chimeric Antigen Receptor T (CAR T) Cell Therapy With Kymriah/tIsagenlecleucel (LOKI)
- ClinicalTrials.gov ID
- NCT06003179
- Acronym / sponsor ID
- LOKI / OZM-123
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: recruitment challenges and sites who initially expressed interest declined.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 21 Aug 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 lymphodepletion (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 chimeric antigen receptor T (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 20-40 patients in the dose escalation stage (Part 1), and approximately 20 further patients at cohort expansion (Part 2). There will be six dose escalation cohorts, in three study arms. There are two dosing cohorts in each study arm. Patients in Arm 1 will receive the JULIET chemotherapy LD regimen with or without TLI, and in Arms 2 and 3, intermediate doses 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). Similarly, enrollment into Arm 3 will only commence once Arm 2 has accrued and relevant safety data has been reviewed.
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 relevant cohorts in Arms 2 and 3, 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 patient enrollment into Arm 2. The same procedure and DLT window will be followed prior to patient enrollment into Arm 3.
One DLT window will be observed during this study: 30 days post infusion of tisagenlecleucel.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
- 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 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 20-40 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 | Active comparator | Drug: Cyclophosphamide, Drug: FludarabineFludarabine 25mg/m2 Cyclophosphamide 250mg/m2 Days -4, -3, -2 |
| Cyclophosphamide and fludarabine, standard dose with radiation | Experimental | Radiation: TLI, Drug: FludarabineFludarabine 25mg/m2 Cyclophosphamide 250mg/m2 Days -6, -5, -4 2 Gy in 2 Fractions Days -3, -2 |
| Cyclophosphamide (intermediate dose) and fludarabine | Experimental | Drug: Cyclophosphamide, Drug: FludarabineFludarabine 25mg/m2 Cyclophosphamide 500mg/m2 Days -4, -3, -2 |
| Cyclophosphamide (intermediate dose) and fludarabine with radiation | Experimental | Drug: Cyclophosphamide, Radiation: TLI, Drug: FludarabineFludarabine 25mg/m2 Cyclophosphamide 500mg/m2 Days -6, -5, -4 2 Gy in 2 Fractions Days -3, -2 |
| Cyclophosphamide (high dose) and fludarabine | Experimental | Drug: Cyclophosphamide, Drug: FludarabineFludarabine 25mg/m2 Cyclophosphamide 750mg/m2 Days -4, -3, -2 |
| Cyclophosphamide (high dose) and fludarabine with radiation | Experimental | Drug: Cyclophosphamide, Radiation: TLI, Drug: FludarabineFludarabine 25mg/m2 Cyclophosphamide 750mg/m2 Days -6, -5, -4 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 (16 listed)
- Age ≥ 18 years at the time of informed consent
- Life expectancy ≥ 12 weeks
- Biopsy-proven and histologically confirmed relapse/refractory (R/R) large B cell lymphoma, including Primary mediastinal B-cell lymphoma (PMBCL), R/R DLBCL and transformation from Follicular lymphoma (FL).
- Radiographically documented measurable disease as per Lugano response criteria (i.e. longest transverse diameter of a lesion (LDi) > 1.5 cm that is [18F] fluorodeoxyglucose (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 (25 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 chronic lymphocytic leukemia (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: Cytoxan, neosarConditioning chemo at different doses | Drug | Cyclophosphamide (high dose) and fludarabine, Cyclophosphamide (high dose) and fludarabine with radiation, Cyclophosphamide (intermediate dose) and fludarabine, Cyclophosphamide (intermediate dose) and fludarabine with radiation, Cyclophosphamide and fludarabine, standard dose |
| TLIradiation given with conditioning chemo | Radiation | Cyclophosphamide (high dose) and fludarabine with radiation, Cyclophosphamide (intermediate dose) and fludarabine with radiation, Cyclophosphamide and fludarabine, standard dose with radiation |
| FludarabineFludarabine given as part of standard treatment | Drug | Cyclophosphamide (high dose) and fludarabine, Cyclophosphamide (high dose) and fludarabine with radiation, Cyclophosphamide (intermediate dose) and fludarabine, Cyclophosphamide (intermediate dose) and fludarabine with radiation, Cyclophosphamide and fludarabine, standard dose, Cyclophosphamide and fludarabine, standard dose with radiation |
Primary outcome
Maximum tolerated dose (MTD) and dose limiting toxicity (DLT) for chemo plus radiation as lymphodepletion
Time frame: baseline through end of study completion, approximately 2 years
(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 (JULIET) 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
6 secondary outcomes
overall response rate (ORR) at 12 months of chemo rads
Time frame: baseline to 12 months post CAR-T
complete response (CR) rate at 12 months of chemo rads
Time frame: baseline to 12 months post CAR-T
progression free survival (PFS) at 12 months of chemo rads
Time frame: baseline to 12 months post CAR-T
ORR at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
Time frame: baseline to 12 months post CAR-T
CR rate at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
Time frame: baseline to 12 months post CAR-T
PFS at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
Time frame: baseline to 12 months post CAR-T
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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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. This study is not recruiting at the moment.
John G Kuruvilla principal investigator
Princess Margaret Cancer Centre - University Health Network
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, TLI and Fludarabine in people with Lymphoma, Large B-Cell, Diffuse, 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 16 inclusion and 25 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: withdrawn, as of the sponsor's last update on 12 Nov 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Maximum tolerated dose (MTD) and dose limiting toxicity (DLT) for chemo plus radiation as lymphodepletion (time frame: baseline through end of study completion, approximately 2 years). 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 12 Nov 2024.