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Alkylating agents

Intense Chemotherapy Regimen for Diffuse Large B-Cell Lymphoma

Phase 2

Waitlist Available

Led By Stephen Noga, MD, PhD

Research Sponsored by The Alvin and Lois Lapidus Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age criteria: 60 years old and older or 18 years old and older with significant/potential cardiac morbidity

New York Heart Association (NYHA) classification of Class III or better

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is testing how well a new, more intense chemotherapy regimen works in treating NHL, and how well patients can tolerate it.

Who is the study for?

This trial is for adults over 60 or those over 18 with heart issues, who have a type of cancer called diffuse large B-cell lymphoma. They should be relatively active and not severely ill from other causes. Key blood and organ function measures must meet certain levels, and they shouldn't have had previous treatments for this cancer.Check my eligibility

What is being tested?

The study tests the safety and workability of giving full doses on time of CDOP-R (a combination of cyclophosphamide, doxil, vincristine, prednisone, rituximab) to patients with non-Hodgkin's lymphoma under a dose-dense regimen every two weeks.See study design

What are the potential side effects?

Possible side effects include nausea, hair loss, mouth sores due to chemotherapy drugs; weakened immune system leading to infections; potential heart problems due to Doxil; nerve damage causing numbness or tingling because of Vincristine.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 60 or older, or I am 18 or older with heart health concerns.

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My heart condition does not severely limit my daily activities.

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I have not received any treatment for my condition.

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My liver tests are within normal limits, unless due to my lymphoma.

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I have been diagnosed with a type of lymphoma that is at any stage.

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I can care for myself but may not be able to do heavy physical work.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Efficacy: tumor evaluations every three (q 3) cycles

Safety assessment: National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v3.0

0 / 6Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Alvin and Lois Lapidus Cancer InstituteLead Sponsor

Ortho Biotech Products, L.P.Industry Sponsor

36 Previous Clinical Trials

5,498 Total Patients Enrolled

Stephen Noga, MD, PhDPrincipal InvestigatorSinai Hospital of Baltimore, The Alvin and Lois Lapidus Cancer Institute

Media Library

Cyclophosphamide (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT00333008 — Phase 2

Non-Hodgkin's Lymphoma Research Study Groups:

Non-Hodgkin's Lymphoma Clinical Trial 2023: Cyclophosphamide Highlights & Side Effects. Trial Name: NCT00333008 — Phase 2

Cyclophosphamide (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00333008 — Phase 2

Frequently Asked Questions

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

Is there still an opportunity for people to join this research trial?

"According to the clinicaltrials.gov database, this trial is not presently enrolling patients; its initial posting was on May 1st 2006 and has been inactive since September 25th of that same year. Nevertheless, there are 1803 other trials actively looking for volunteers at this moment in time."

Answered by AI

Has this therapeutic method been acknowledged by the FDA?

"Our team has assigned a risk rating of 2 to this treatment due to its Phase 2 trial status, suggesting that the safety profile is established but efficacy remains untested."

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Do I fulfill the qualifications to participate in this experiment?

"This study is searching for 27 individuals, aged 18 or higher and below 60 who are currently struggling with the diagnosis of diffuse large B-cell lymphoma (Ann Arbor Stages I - IV) in any International Prognostic Index score. The patient's Eastern Cooperative Oncology Group performance status must be 0 to 3, and they cannot have received prior treatment."

Answered by AI