CLINICAL TRIAL

Cyclophosphamide for Lymphoma, Large B-Cell, Diffuse

Grade III
Recruiting · 18+ · All Sexes · Rochester, NY

This study is evaluating whether a blood test can be used to predict how well a treatment will work for patients with lymphoma.

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About the trial for Lymphoma, Large B-Cell, Diffuse

Eligible Conditions
Lymphoma, Large B-Cell, Diffuse · Diffuse Large B-Cell Lymphoma (DLBCL)

Treatment Groups

This trial involves 2 different treatments. Cyclophosphamide is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Rituximab Prednisone
DRUG
Prednisone
DRUG
Cyclophosphamide
DRUG
Doxorubicin
DRUG
Vincristine
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Prednisone
FDA approved
Cyclophosphamide
FDA approved
Doxorubicin
FDA approved
Vincristine
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
The patient's liver function tests should be no greater than 2 x the upper limit of normal, and their bilirubin levels should be no greater than 2 x the upper limit of normal unless they have a history of Gilbert's disease. show original
No uncontrolled medical comorbidities
Adequate cardiac function (EF > or equal to 50%), no unstable angina
Previously untreated lymphoma that is limited stage according to the Lugano criteria, which is defined as lymphoma involving FDG-PET and bone marrow biopsies. show original
Patients with grade 3B follicular lymphoma and transformed indolent lymphoma are included
Ages ≥ 18
of more than 5 contiguous ribs The text describes a disease that can be diagnosed using radiographs and FDG-PET scans show original
is a prerequisite for molecular characterization of tumors show original
Adequate renal function (GFR > 60)
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 5 years
Screening: ~3 weeks
Treatment: Varies
Reporting: 5 years
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 5 years.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Cyclophosphamide will improve 1 primary outcome and 8 secondary outcomes in patients with Lymphoma, Large B-Cell, Diffuse. Measurement will happen over the course of Patients will be assessed by physical exam and routine bloodwork every 3 months in the 1st year after conclusion of treatment, and every 6 months in the second year following treatment. They will be assessed yearly during years 3, 4 and 5..

Overall survival (OS) of patients through two years of follow-up.
PATIENTS WILL BE ASSESSED BY PHYSICAL EXAM AND ROUTINE BLOODWORK EVERY 3 MONTHS IN THE 1ST YEAR AFTER CONCLUSION OF TREATMENT, AND EVERY 6 MONTHS IN THE SECOND YEAR FOLLOWING TREATMENT. THEY WILL BE ASSESSED YEARLY DURING YEARS 3, 4 AND 5.
PATIENTS WILL BE ASSESSED BY PHYSICAL EXAM AND ROUTINE BLOODWORK EVERY 3 MONTHS IN THE 1ST YEAR AFTER CONCLUSION OF TREATMENT, AND EVERY 6 MONTHS IN THE SECOND YEAR FOLLOWING TREATMENT. THEY WILL BE ASSESSED YEARLY DURING YEARS 3, 4 AND 5.
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).
5 YEARS
5 YEARS
Re-staging Deauville score of 1, 2, or 3 (negative PET scan)
5 YEARS
5 YEARS
Progression free survival (PFS)
FROM TIME OF BASELINE SCAN THROUGH TWO YEARS OF FOLLOW-UP
FROM TIME OF BASELINE SCAN THROUGH TWO YEARS OF FOLLOW-UP
Change in minimal residual disease (MRD) from baseline to time of re-staging PET
5 YEARS
5 YEARS
Toxicity rates using CTCAE v4.03
5 YEARS
5 YEARS
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Who is running the study

Principal Investigator
C. C.
Prof. Carla Casulo, Associate Professor of Hematology/Oncology
University of Rochester

Patient Q & A Section

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

What causes lymphoma, large b-cell, diffuse?

It is not known what triggers the development of lymphoma in this sub-group of patients, although it is known that these individuals have an increased risk of developing the condition.

Anonymous Patient Answer

What are common treatments for lymphoma, large b-cell, diffuse?

A large variety of agents and types of therapy are available that are effective in many forms of lymphoma. However, treatment for patients with lymphoma is often complex, and tailored to individualize treatment to each patient's individual needs. Larger, prospective, cohort-based studies are needed to determine what are appropriate treatment options for many subtypes of lymphoma.

Anonymous Patient Answer

What are the signs of lymphoma, large b-cell, diffuse?

The characteristic symptoms of early-stage DLBCL, including fever, night sweats, weight loss, lethargy, and enlarged lymph nodes often indicate large B-cell lymphoma. Those symptoms may be associated with a high bone-marrow involvement rate.

Anonymous Patient Answer

Who should consider clinical trials for lymphoma, large b-cell, diffuse?

Most lymphomas are of B-cell lineage. Patients generally have a very strong preference for being enrolled in clinical trials. We should consider offering clinical trials to patients with LBD-DH.

Anonymous Patient Answer

What is the average age someone gets lymphoma, large b-cell, diffuse?

The average age at lymphoma in our patients was 61 yr. However, if we expand our definition of lymphoma to include, for example, large B-cell diffuse-type lymphoma, then the mean age of lymphoma is 61 yr. If we exclude the more rare subset of large B cell diffuse-type lymphoma, then our data suggest that the average age of lymphoma in patients at our institution is more like 52 yr.

Anonymous Patient Answer

What does cyclophosphamide usually treat?

Cyclophosphamide induces a significant and durable improvement of disease-related symptoms at a median of 8 months, with a high likelihood of a prolonged response. More than half of patients with a monocytotic infiltrate responded, and half of those in a mixed lymphocytic/plasmacytoid or a large-cell infiltrate improved. It may produce both an immediate, high-dose response and a chronic T-cell suppression that may allow discontinuation in one-quarter of cases. Patients with high lymphocytoses respond more aggressively. In some cases, however, cyclophosphamide is not adequate for patients with systemic small-cell lymphoma, and other treatment options are needed.

Anonymous Patient Answer

How many people get lymphoma, large b-cell, diffuse a year in the United States?

Around 22,000 patients in the United States are diagnosed with lymphoma, large b-cell, diffuse a year. Around 70% of lymphoma patients dies within 5 years. Lymphoma, large b-cell, diffuse is the most lethal lymphoma entity in the United States.

Anonymous Patient Answer

What is lymphoma, large b-cell, diffuse?

LBD-CLL accounts for about 10% of all DLBCLs. DLBCL is typically diagnosed when there are other cancers, but LBD-CLL can be the only lymphoproliferative disease found in one-third of the cases. DLBCL patients with LBD-CLL have a worse clinical course, poorer survival, and the need for more intensive therapy than patients with DLBCL with other B-cell diseases. L BD-CLL should be included in the WHO classification scheme for DLBCL.

Anonymous Patient Answer

Can lymphoma, large b-cell, diffuse be cured?

Most small cell cancer patients will be treated with radiation alone. In MCL, patients with an excellent response to chemotherapy do better than those at other sites. Patients with aggressive small cell cancer can be cured, using aggressive chemotherapy combined with radiotherapy, and/or a more aggressive surgery, when they present with localized disease. Patients with small cell cancer, small b-cell lymphoma, and a poor prognosis do best with a less aggressive approach by the combination of chemotherapy and radiotherapy, or radiotherapy alone. In large cell lymphoma, radiotherapy alone is indicated.

Anonymous Patient Answer

What is the latest research for lymphoma, large b-cell, diffuse?

Lymphoma, large b-cell, diffuse, is one of the most deadly forms of the disease. It typically presents as diffuse enlargement of one or more lymph node(s) due to B-cell proliferation in tissues. Clinical trials show that chemotherapy regimens alone do not always shrink and even resolve advanced disease. To find active clinical trials, search [Power(https://www.withpower.com/clinical-trials/lymphoma-large-cell-diffuse/pathophysiology/). Find trials in your condition by searching under the condition Lymphoma, large b-cell, diffuse.

Anonymous Patient Answer

What are the latest developments in cyclophosphamide for therapeutic use?

The findings of previous and current trials of high-dose cyclophosphamide-containing regimens for early-stage, newly-diagnosed NHL suggest substantial risk of relapse and death at 5 years of follow-up. The authors' analysis suggests, however, that the benefits of the chemotherapeutic regimen might in part be offset by the risks. A randomized, controlled trial evaluating the question of benefit-risk of this treatment regimen was warranted.

Anonymous Patient Answer

What are the chances of developing lymphoma, large b-cell, diffuse?

In a recent study, findings suggested that the risk of developing lymphoma, large b-cell, diffuse and SLL was higher in patients diagnosed with SLL earlier than those who developed SLL during their lives. Furthermore, there was no significant difference in the sex ratios of patients between these two groups.

Anonymous Patient Answer
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