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Alkylating agents

PET Adapted Therapy for Non-Hodgkin's Lymphoma

Phase 2
Recruiting
Led By Carla Casulo
Research Sponsored by University of Rochester
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Measurable disease, assessable by radiographic examination with FDG-PET showing involvement
Access to archived or fresh/frozen tumor biopsies
Must not have
Bulky disease greater than 10 cm in any dimension
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing whether a certain type of blood test can be used to detect early signs of cancer recurrence in people with a certain type of lymphoma.

Who is the study for?
This trial is for adults over 18 with early stage, non-bulky Diffuse Large B-Cell Lymphoma (DLBCL) who haven't been treated before. Participants need measurable disease visible on PET scans and available tumor biopsies. They must have good heart, kidney, liver function, stable blood counts, and no uncontrolled health issues or pregnancy.
What is being tested?
The study tests how well patients respond to a combination of drugs: Vincristine, Prednisone, Rituximab Prednisone, Cyclophosphamide, Doxorubicin. It also monitors circulating tumor DNA levels in the body to potentially adapt treatment based on response.
What are the potential side effects?
Possible side effects include nausea and vomiting from chemotherapy drugs like Doxorubicin and Cyclophosphamide; nerve damage from Vincristine; increased infection risk due to immune system impact by Rituximab; fluid retention or mood changes from Prednisone.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My cancer can be seen and measured on a PET scan.
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I can provide samples of my tumor for testing.
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My heart is strong (EF ≥ 50%) and I don't have unstable chest pain.
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My lymphoma is in an early stage and hasn't spread widely.
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My kidneys are working well.
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My cancer is larger than 10 cm in size.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Baseline PETExperimental Treatment5 Interventions
R-CHOP
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
2014
Completed Phase 4
~2500
Vincristine
2003
Completed Phase 4
~2970
Cyclophosphamide
2010
Completed Phase 4
~2310
Doxorubicin
2012
Completed Phase 3
~8030

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor
872 Previous Clinical Trials
550,051 Total Patients Enrolled
Carla Casulo5.05 ReviewsPrincipal Investigator - University of Rochester
University of Rochester
5Patient Review
She was extremely knowledgeable and caring, taking the time to understand my needs. I would definitely recommend her!

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT03758989 — Phase 2
Non-Hodgkin's Lymphoma Research Study Groups: Baseline PET
Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT03758989 — Phase 2
Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03758989 — Phase 2
~6 spots leftby Dec 2025
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