Vincristine Sulfate for Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Ohio State University Comprehensive Cancer Center, Columbus, OH
Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma+6 More
Vincristine Sulfate - Drug
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether a combination of drugs may help treat patients with lymphoma.

See full description

Eligible Conditions

  • Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma
  • Diffuse Large B-Cell Lymphoma (DLBCL)
  • Transformed Follicular Lymphoma to Diffuse Large B Cell Lymphoma

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Study Objectives

This trial is evaluating whether Vincristine Sulfate will improve 1 primary outcome and 10 secondary outcomes in patients with Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma. Measurement will happen over the course of Up to 6 cycles (each cycle is 21 days in length).

Month 24
Overall survival (OS)
Month 24
Progression-free survival
Up to 24 months
Incidence of adverse events
Objective response rate (ORR)
Day 21
Number of rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, and prednisone (R-CHOP) cycles received
R-CHOP discontinuation rates
R-CHOP relative dose intensity
Zanubrutinib average daily dose
Zanubrutinib discontinuation rate
Zanubrutinib duration of treatment
Zanubrutinib relative dose intensity

Trial Safety

Safety Progress

1 of 3

Other trials for Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma

Trial Design

1 Treatment Group

Treatment (zanubrutinib, R-CHOP)
1 of 1
Experimental Treatment

This trial requires 24 total participants across 1 different treatment group

This trial involves a single treatment. Vincristine Sulfate 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 1 and are in the first stage of evaluation with people.

Treatment (zanubrutinib, R-CHOP)Patients receive zanubrutinib PO on days 1-21, rituximab IV on day 1, cyclophosphamide IV on day 1, doxorubicin hydrochloride IV on day 1, vincristine sulfate IV on day 1, and prednisone PO QD on days 1-5. Treatment repeats every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sulfate ion
Not yet FDA approved
Zanubrutinib
FDA approved
Rituximab
FDA approved
Methylprednisolone
FDA approved
Doxorubicin
FDA approved
Cyclophosphamide
FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 24 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 24 months for reporting.

Closest Location

Ohio State University Comprehensive Cancer Center - Columbus, OH

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. You must have received newly diagnosed for Transformed Marginal Zone Lymphoma to Diffuse Large B-Cell Lymphoma or one of the other 6 conditions listed above. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
Patients must have histologically confirmed DLBCL, irrespective of cell-of-origin. Patients with previously diagnosed indolent lymphoma (follicular lymphoma and marginal zone lymphoma but not small lymphocytic lymphoma) who have transformed to DLBCL are eligible only if they have not previously been treated for indolent lymphoma except for local radiation for early-stage disease
Patients may have received brief treatment with glucocorticoids (up to 250 mg/day prednisone or equivalent for a maximum of 10 days) and/or 1 cycle of chemotherapy such as R-CHOP (or some component[s] thereof) for the diagnosis of B-cell lymphoma provided they had staging computed tomography (CT) and/or positron emission tomography (PET)/CT scans prior to glucocorticoids and/or chemotherapy. Treatment must occur within 28 days prior to enrollment
Age >= 18 years. Because no dosing or adverse event data are currently available on the use of zanubrutinib in combination with R-CHOP in patients <18 years of age, children are excluded from this study
Eastern Cooperative Oncology Group (ECOG) performance status =< 2. Performance status of 3 will be accepted if the impairment is caused by DLBCL complications and improvement is expected once therapy is initiated
Measurable disease (defined as >= 1.5cm in diameter) or at least one PET fludeoxyglucose F-18 (FDG) avid area of disease
Hemoglobin >= 7.0 g/dL
Absolute neutrophil count (ANC) > 1,000/mcL
Platelet count > 75,000/mcL
Total bilirubin =< 1.5 x the upper limit of the normal range (ULN) (unless due to Gilbert's disease)
Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) < 2.5 x institutional ULN

Patient Q&A Section

What causes lymphoma, b-cell?

"This article describes lymphomas, including small non-Hodgkin lymphoma, MALT lymphoma, Mantle cell lymphoma, and chronic lymphocytic leukemia. Chronic lymphocytic leukemia may be caused by a faulty immune system. The causes of lymphoma, b-cell are not yet clearly defined.\n" - Anonymous Online Contributor

Unverified Answer

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

"About 30,000 US adults develop lymphoma each year. This is a similar incidence to that seen in Western Europe, with no evidence of an international increase in incidence for the disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of lymphoma, b-cell?

"Symptoms of lymphoma, b-cell are frequently a poor quality of life. The most common symptoms are bone pain, persistent or progressive systemic symptoms which can cause the patients to lose their appetite, swollen lymph nodes, shortness of breath or a weight loss. Lymphoma, b-cell affects about 3-4 new cases in Canadian every year\n" - Anonymous Online Contributor

Unverified Answer

Can lymphoma, b-cell be cured?

"There are more than 1,100 clinical trials enrolling patients for lymphoma therapy. Many of studies are evaluating novel agents or combinations regimens that are either proven to be more effective than standard agents or have a better toxicity profile. Because clinical trials vary, the outcome can be different depending on how you are selected. Please see Power, or withPower.com." - Anonymous Online Contributor

Unverified Answer

What are common treatments for lymphoma, b-cell?

"Lymphoma is treated with chemotherapy, depending on the stage of the disease. The most common stage of disease treated is early B-cell lymphoma with B-cell chronic lymphocytic leukemia being treated the most with chemotherapy. Immunotherapy and targeted therapies are becoming more common, especially in early stage disease. Overall five year survival rates from lymphoma are improving with treatment. This is primarily achieved from the development of more effective chemotherapy regimens and the increased use of new drugs and targeted therapies. Chemotherapy also has an effect on remission rates as does targeted therapy." - Anonymous Online Contributor

Unverified Answer

What is lymphoma, b-cell?

"Chronic lymphoproliferative disorders compose >1% of all diagnoses in the US. Lymphoma is also a leading cause of death in most parts of the world. This article provides a review of the clinical features, diagnostic and pathological features, treatment options and prognosis for these disorders." - Anonymous Online Contributor

Unverified Answer

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

"These data indicate that lymphoma patients, particularly non-Hodgkin's lymphoma, who are younger than 65 years and have a poorer baseline performance status are potential candidates for clinical trials of the FDA-approved agents. This group also has the greatest potential to improve clinical trial outcomes, both for patients and health care systems." - Anonymous Online Contributor

Unverified Answer

What is the survival rate for lymphoma, b-cell?

"In the past, the five-year survival rate for patients with lymphoma and the b-cell subtypes was the same (0.5%). In the present, with the advent of rituximab, a monoclonal antibody against B-cell, that has been shown to be effective for aggressive aggressive lymphomas (MALT/NOS and mantle cell/sessile cell lymphomas), the five-year survival rate is considerably increased. This is based on a recent report." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of lymphoma, b-cell?

"We hypothesize that lymphoma in AIDS is due to Epstein-Barr virus infection. Further, this virus is likely transmitted sexually and is not a natural part of human immunity. In an attempt to reduce transmission, HIV-positive individuals should abstain from sexual contact, and condoms may be used with care; these practices should be introduced as early as possible. Because the time interval between onset of HIV infection and development of lymphoma in that individual is highly variable, prophylactic chemotherapy directed toward HIV infection is not recommended." - Anonymous Online Contributor

Unverified Answer

How quickly does lymphoma, b-cell spread?

"B-cell lymphoma is still evolving and the incidence seems to be increasing, however the duration for lymphoma to develop is still shorter than expected. Some clinical trials (in particular CHOP) were less effective than expected even though they had been done for 30 years." - Anonymous Online Contributor

Unverified Answer

Does lymphoma, b-cell run in families?

"Results from a recent clinical trial do not support the hypothesis that B-NHL families share an increased susceptibility for some B-NHL subtypes. To our knowledge, this is the first large-scale family-based evaluation of family history of B-NHL." - Anonymous Online Contributor

Unverified Answer

What is cyclophosphamide?

"[The mechanism of action of cyclophosphamide on lymphomas is to prevent the abnormal proliferation of B-cells. This does not appear to be directly through a cytotoxic effect by cytotoxic chemotherapy. The mechanism appears to be inhibition of pre B-cell differentiation.]" - Anonymous Online Contributor

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