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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 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

Correlation between fluorodeoxyglucose positron emission tomography (FDG-PET) and MRD, as measured by circulating tumor plasma DNA (ctDNA) in patients with early stage diffuse large B cell lymphoma (DLBCL).

Secondary outcome measures

Change in minimal residual disease (MRD) from baseline to time of re-staging PET

Changes in quality of life using PROMIS scale 10 scale will be administered to patients at the time of diagnosis, at the conclusion of all therapy, and at 12 month intervals

Following 3 cycles of R-CHOP, if PET scan demonstrates complete response, defined by Deauville score of 1, 2, or 3 (negative PET scan), radiation therapy will not be required moving forward

+5 more

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

Vincristine

2003

Completed Phase 4

~2910

Prednisone

2014

Completed Phase 4

~2370

Cyclophosphamide

1995

Completed Phase 3

~3770

Doxorubicin

2012

Completed Phase 3

~7940

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of RochesterLead Sponsor

838 Previous Clinical Trials

518,527 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the Cyclophosphamide drug been federally approved in the United States?

"Cyclophosphamide was given a score of 2 by our team because, while there is some evidence backing its safety, no Phase 2 trials have been run to test efficacy."

Answered by AI

Are patients still being sought for this clinical research?

"That is correct. The clinicaltrials.gov website corroborates that this study, which was established on May 8th, 2019, is still looking for 40 patients at 1 medical facility."

Answered by AI

What is the total amount of enrollees in this clinical trial?

"That is correct, the clinical trial indicated on clinicaltrials.gov is currently looking for 40 patients from 1 site. The study was posted on 5/8/2019 and updated recently on 7/8/2022."

Answered by AI

What are some of the conditions that Cyclophosphamide has been used to effectively manage?

"While often used to treat lung cancers, Cyclophosphamide can also help patients suffering from small cell lung cancer (sclc), thyroiditis, and polyangium."

Answered by AI

Could you list any other research that has been done on Cyclophosphamide?

"As of now, there are 1483 live trials researching Cyclophosphamide with 317 trials in Phase 3. While the majority of the clinical trials for Cyclophosphamide are running out of in Bethesda, Maryland, 51873 other locations across the globe are also conducting research on this medication."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma

Carla Casulo 2019. "A Study of PET Adapted Therapy and Non-invasive Monitoring for Previously Untreated Limited Stage Diffuse Large B Cell Lymphoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03758989.

All > Diffuse Large B Cell Lymphoma