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Alkylating agents

Optimizing Lymphodepletion for Diffuse Large B-Cell Lymphoma (LOKI Trial)

Phase 1
Recruiting
Led By John G Kuruvilla
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
Patient does not have active central nervous system (CNS) disease
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 at enrollment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through end of study completion, approximately 2 years
Awards & highlights

Summary

"This trial is testing different doses of two drugs, Fludarabine and Cyclophosphamide, with or without total lymphoid irradiation in patients with Diffuse Large B Cell Lymph

Who is the study for?
Adults over 18 with relapsed/refractory large B-cell lymphoma, including specific subtypes like PMBCL and DLBCL. Candidates must have completed previous cancer treatments at least 2 weeks prior, show no active CNS disease, have a life expectancy of more than 12 weeks, and not be HIV positive or previously received T-cell therapy.
What is being tested?
The study is testing different doses of Fludarabine and Cyclophosphamide with or without total lymphoid irradiation (TLI) to find the best way to prepare patients for CAR T cell therapy in treating Diffuse Large B-Cell Lymphoma.
What are the potential side effects?
Potential side effects include lowered blood counts leading to increased infection risk, nausea, fatigue from chemotherapy drugs Fludarabine and Cyclophosphamide; radiation-related side effects may occur with TLI.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I do not have an active brain disease.
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I am fully active or have some restrictions but can still care for myself.
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I am 18 years old or older.
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I am stable enough for CAR T-cell therapy and do not need intensive care support.
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I have never had T-cell immunotherapy.
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I do not have HIV.
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My large B-cell lymphoma has returned or didn't respond to treatment.
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My scans show a tumor larger than 1.5 cm that absorbs a specific dye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through end of study completion, approximately 2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through end of study completion, approximately 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum tolerated dose (MTD) and dose limiting toxicity (DLT) for chemo plus radiation as lymphodepletion
Secondary outcome measures
CR rate at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
ORR at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
PFS at 12 months of an intermediate dose iCy/Flu +/- TLI LD regimen
+3 more
Other outcome measures
Assessments

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: Cyclophosphamide and fludarabine, standard dose with radiationExperimental Treatment2 Interventions
Fludarabine 25mg/m2 Cyclophosphamide 250mg/m2 Days -6, -5, -4 2 Gy in 2 Fractions Days -3, -2
Group II: Cyclophosphamide (intermediate dose) and fludarabine with radiationExperimental Treatment3 Interventions
Fludarabine 25mg/m2 Cyclophosphamide 500mg/m2 Days -6, -5, -4 2 Gy in 2 Fractions Days -3, -2
Group III: Cyclophosphamide (intermediate dose) and fludarabineExperimental Treatment2 Interventions
Fludarabine 25mg/m2 Cyclophosphamide 500mg/m2 Days -4, -3, -2
Group IV: Cyclophosphamide (high dose) and fludarabine with radiationExperimental Treatment3 Interventions
Fludarabine 25mg/m2 Cyclophosphamide 750mg/m2 Days -6, -5, -4 2 Gy in 2 Fractions Days -3, -2
Group V: Cyclophosphamide (high dose) and fludarabineExperimental Treatment2 Interventions
Fludarabine 25mg/m2 Cyclophosphamide 750mg/m2 Days -4, -3, -2
Group VI: Cyclophosphamide and fludarabine, standard doseActive Control2 Interventions
Fludarabine 25mg/m2 Cyclophosphamide 250mg/m2 Days -4, -3, -2
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cyclophosphamide
2010
Completed Phase 4
~2320
Fludarabine
2012
Completed Phase 4
~1860

Find a Location

Who is running the clinical trial?

University Health Network, TorontoLead Sponsor
1,514 Previous Clinical Trials
500,165 Total Patients Enrolled
John G KuruvillaPrincipal InvestigatorPrincess Margaret Cancer Centre - University Health Network
~27 spots leftby Nov 2026
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