R-CHOP (Negative Mid-Treatment PET Scan) for Non-Hodgkin's Lymphoma (LYTPET Trial)

Phase 2

Waitlist Available

Led By Laurie H Sehn, MD

Research Sponsored by British Columbia Cancer Agency

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 estimated two years

Awards & highlights

Approved for 60 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is assessing whether patients who are likely to fail R-CHOP, as predicted by a mid-treatment PET scan, can have an improved outcome if switched to a standard salvage regimen R-ICE.

Eligible Conditions

Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ several years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~several years

This trial's timeline: 3 weeks for screening, Varies for treatment, and several years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Progression-free survival (PFS) in participants with advanced stage DLBCL

Secondary study objectives

Efficacy of tailoring first-line therapy bases on a mid-treatment PET scan result for patients with advanced stage DLBCL

Investigate clinical and biologic markers that characterize participant heterogeneity and may serve as predictors of response to therapy and overall outcome.

Overall survival (OS) in participants with advanced stage DLBCL

Awards & Highlights

Approved for 60 Other Conditions

This treatment demonstrated efficacy for 60 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Active Control

Group I: R-CHOP (Negative Mid-Treatment PET Scan)Active Control9 Interventions

All participants will receive 4 cycles of standard dose R-CHOP chemotherapy administered at 3-weekly intervals. Non-progressing participants will undergo a mid-treatment PET scan along with routine restaging investigations after 4 cycles of R-CHOP. Patients with a negative mid-treatment PET scan (no evidence of abnormal 18F-FDG uptake) will complete therapy with two additional cycles of R-CHOP for a total of 6 cycles of chemotherapy. Patients with a mid-treatment PET scan interpreted to be "indeterminate" or "equivocal" will be recorded as such, but should be considered negative for the purpose of treatment planning and should not prompt a change in therapy.

Group II: R-ICE (Positive Mid-Treatment PET ScanActive Control15 Interventions

All participants will receive 4 cycles of standard dose R-CHOP chemotherapy administered at 3-weekly intervals. Non-progressing participants will undergo a mid-treatment PET scan along with routine restaging investigations after 4 cycles of R-CHOP. Patients with a mid-treatment PET scan (abnormal 18F-FDG uptake) will be switched to R-ICE chemotherapy and receive 4 cycles of R-ICE for a total of 8 cycles of chemotherapy. Following completion of R-ICE chemotherapy, patients will undergo a post-treatment PET scan along with routine restaging investigations. The post-treatment PET scan will be performed between days 28 and 35 following the final cycle of R-ICE. Patients with a negative post-treatment PET scan will undergo no further therapy. Patients with a positive post-treatment PET scan corresponding to persistent abnormalities on CT scan will be considered for radiation therapy to PET positive sites.

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