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Optimized Lymphodepletion + CAR T Therapy for Diffuse Large B-Cell Lymphoma (ODIN Trial)
Phase 1
Recruiting
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through day 365
Awards & highlights
No Placebo-Only Group
Summary
This trial is studying an optimized lymphodenpletion regimen for Diffuse Large B Cell Lymphoma in combination with CAR T cell therapy.
Who is the study for?
Adults with Diffuse Large B Cell Lymphoma who haven't had adoptive T-cell immunotherapy or allogeneic stem cell transplant, have good organ function and life expectancy of at least 12 weeks. They must not be HIV positive, pregnant, or breastfeeding and agree to use contraception. Participants need measurable disease per Lugano criteria and should be eligible for standard CAR T cell therapy after at least two systemic therapies.
What is being tested?
The trial is testing different pre-treatment regimens (lymphodepletion) before CAR T cell therapy in DLBCL patients. It compares standard and intermediate doses of Fludarabine/Cyclophosphamide with/without total lymphoid irradiation (TLI) to find the best way to prepare patients for the subsequent CAR T treatment.
What are the potential side effects?
Potential side effects include those from chemotherapy like nausea, hair loss, mouth sores; from radiation such as skin irritation; and from CAR T therapy which can cause fever, difficulty breathing, confusion among others due to immune system activation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through day 365
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through day 365
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
safety and tolerability of chemo rads as conditioning chemo
Secondary study objectives
Complete response
Overall response rate
Progression free survival
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Cyclophosphamide and fludarabine, standard dose with radiationExperimental Treatment2 Interventions
Fludarabine 30mg/m2 Cyclophosphamide 500mg/m2 Days -6, -5, -4, and 2 Gy in 2 Fractions Days -3, -2
Group II: Cyclophosphamide (intermediate dose) and fludarabine with radiationExperimental Treatment2 Interventions
Fludarabine 30mg/m2 Cyclophosphamide 750mg/m2 Days -6, -5, -4, and 2 Gy in 2 Fractions Days -3, -2
Group III: Cyclophosphamide (intermediate dose) and fludarabineExperimental Treatment1 Intervention
Fludarabine 30mg/m2 Cyclophosphamide 750mg/m2 Days -4, -3, -2
Group IV: Cyclophosphamide and fludarabine, standard doseActive Control1 Intervention
Fludarabine 30mg/m2 Cyclophosphamide 500mg/m2 Days -4, -3, -2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2310
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,521 Previous Clinical Trials
503,264 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer is still large (at least 10 cm) after initial treatment.I haven't taken Ibrutinib, lenalidomide, or PI3K inhibitors recently.I have received treatment targeting CD19 before.I haven't taken experimental drugs within the last 4 weeks or have waited 5 half-lives after such treatment.I have had CAR-T cell therapy or other genetic modifications.I am stable enough for CAR T-cell therapy and do not need intensive care support.I've had radiation recently but still have active cancer or new areas of cancer.I have active tuberculosis.I have a medical tube inserted, but Ports or Hickman catheters are okay.I have had a blood clot in my leg or lung in the past 6 months.It's been over 2 weeks or 5 half-lives since my last cancer treatment.My heart, lungs, liver, kidneys, and bone marrow are working well.I do not have an active brain disease.I do not have HIV.I have not had a stem cell transplant from another person.My non-mobilized cells are approved for manufacturing.I am 18 years old or older.I agree to use a condom during sex for 6 months after treatment to prevent drug exposure.I have an autoimmune disease and have been on systemic treatment in the past 2 years.My scans show cancer that can be measured and is active.I haven't taken high doses of steroids (more than 20 mg/day of prednisone or equivalent) in the last week.I am not pregnant and cannot become pregnant due to surgery or being postmenopausal for 2+ years.I haven't taken any immune-suppressing drugs in the last 4 weeks.I have a serious brain or nerve condition not related to cancer.I have had a stem cell transplant from a donor.I have been cancer-free for 3 years, except for non-dangerous skin cancers.I haven't had certain strong chemotherapy drugs in the last 4 weeks.My CLL has transformed into a more aggressive form.I have had fewer than 2 treatments for large B cell lymphoma.I am fully active or restricted in physically strenuous activity but can do light work.My condition is relapsed or refractory large B-cell lymphoma.I have had CNS lymphoma but it is not currently active.I have a history of lung scarring or inflammation but not from radiation.I have never had T-cell immunotherapy.I do not have any serious infections, or if I do, they are under control without IV drugs.I haven't had serious heart issues like a heart attack or heart failure in the last year.I need urgent treatment because my tumor is causing blockages or pressing on blood vessels.I qualify for CAR T cell therapy for my B cell lymphoma after trying at least two other treatments.I have HIV or hepatitis B/C, but if treated, my viral load is undetectable.My lymphoma affects my heart's atrium or ventricle.I have not received a live vaccine in the last 6 weeks and do not plan to during the study.I stopped taking certain chemotherapy drugs that are not harmful to my immune system 7 days before a special blood filtering procedure.I haven't taken any immune-boosting drugs within the last 6 weeks or before their effects wear off.
Research Study Groups:
This trial has the following groups:- Group 1: Cyclophosphamide (intermediate dose) and fludarabine with radiation
- Group 2: Cyclophosphamide and fludarabine, standard dose
- Group 3: Cyclophosphamide and fludarabine, standard dose with radiation
- Group 4: Cyclophosphamide (intermediate dose) and fludarabine
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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