Symptoms and General Pathology

All Conditions

Neoplasms

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Recurrence

Lymphoma, Large B-Cell, Diffuse

Lymphoma

Lymphoma, B-Cell

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

B-cell Lymphoma

Diffuse Large B-Cell Lymphoma

Lymphosarcoma

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Anti-Inflammatory Agents

Anti-Infective Agents

Cyclophosphamide

Doxorubicin

Liposomal doxorubicin

Prednisone

Rituximab

Vincristine

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Antineoplastic Agents, Immunological

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Glucocorticoids

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Tubulin Modulators

Antimitotic Agents

Patients will receive R-CHOP for 6 to 8 cycles:

* Rituximab 375 mg/m2 on day 1
* Cyclophosphamide 750 mg/m2 IV on day 1
* Doxorubicin 50 mg/m2 on day 1
* Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
* Prednisone 100 mg orally days 1-5, repeated every 21 days.

Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles

Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles

Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles

Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.

Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles

Izidore S. Lossos, MD

The investigators hypothesize that survival of newly diagnosed DLBCL (diffuse large B-cell lymphoma) patients treated with R-CHOP can be predicted by RNA or protein gene expression or by presence of biomarkers associated with the anti-tumor effects of Rituximab.

In this phase II multi-institutional trial, the investigators will identify genes associated with either good or bad outcome in DLBCL patients treated with R-CHOP, will construct a robust predictive models based on RNA extracted from or paraffin specimens as well on immunohistochemistry and will examine the predictive power of new biomarkers associated with the anti-tumor effects of rituximab. The acquisition of fixed tissue as a component of this uniformly treated prospective study will also afford future studies with this informative dataset.

Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)

Phase II Study to Establish Gene Expression Models Predicting Survival of Diffuse Large B-Cell Lymphoma Patients Treated With R-CHOP

The investigators aim to determine a list of genes and construct survival prediction model(s) that will predict the overall survival at 30 months in DLBCL patients prospectively treated with R-CHOP chemotherapy. Overall survival time will be calculated from the date of the diagnosis until death or last follow-up examination.

The investigators aim to determine the usefulness of biomarkers associated with the antitumor effects of rituximab (e.g. immunoglobulin GFc receptor genotypes, CD20 protein expression and gene expression profiles) to predict overall survival of DLBCL patients treated with R-CHOP therapy and followed for at least 24 months or until death.

The investigators will compare the ability of constructed survival models to predict survival in DLBCL patients receiving R-CHOP therapy

The investigators aim to determine the ability of the models and/or biomarkers associated with the anti-tumor effects of rituximab to predict 24-month time to treatment failure, defined as disease progression, death or initiation of new treatment.

Rate of participants achieving complete response (CR), complete response/unconfirmed (CRu) partial response (PR) according to Non-Hodgkin's Lymphoma response criteria.

Number of participants from whom paraffin-embedded DLBCL tissue samples were collected for future studies.

University of Miami

Professor

R-CHOP

Age, Categorical

Sex: Female, Male

United States

Region of Enrollment

Izidore Lossos MD

The study required a minimum of 90 participants for gene expression analyses from which survival prediction model(s) could be derived. Due to actual participant accrual (57) being far below the minimum number of participants required, no data were collected on gene expression, and no survival prediction models were constructed.

Determination of a List of Genes and Construction of Survival Prediction Models That Will Predict Overall Survival at 30 Months in DLBCL Patients Receiving R-CHOP Therapy.

The study required a minimum of 90 participants for associated biomarker analyses. Due to actual participant accrual (57) being far below the minimum number of participants required, no biomarker data were collected.

Usefulness of Biomarkers Associated With Anti-Tumor Effects of Rituximab in Predicting Overall Survival in DLBCL Patients Receiving R-CHOP Therapy

The comparison could not be made because the study required a minimum of 90 participants for initial gene expression analyses from which survival prediction model(s) would be derived. Due to actual participant accrual (57) being far below the minimum number of participants required, no gene expression or survival prediction data were collected.

Comparison of the Ability of Constructed Survival Models to Predict Overall Survival in DLBCL Patients Receiving R-CHOP Therapy

The determination could not be made because the study required a minimum of 90 participants for biomarker analyses and derivation of survival prediction model(s). Due to actual participant accrual (57) being far below the minimum required, no data were collected on the ability of models and/or biomarkers to predict time to treatment failure.

Determination of the Ability of Models and/or Biomarkers Associated With Anti-Tumor Effects of Rituximab to Predict 24-month Time to Treatment Failure in DLBCL Patients Receiving R-CHOP Therapy

Overall Response Rate of Study Participants at the End of Protocol Therapy

Patients will receive R-CHOP for 6 to 8 cycles:

* Rituximab 375 mg/m2 on day 1
* Cyclophosphamide 750 mg/m2 IV on day 1
* Doxorubicin 50 mg/m2 on day 1
* Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1
* Prednisone 100 mg orally days 1-5, repeated every 21 days.

Rituximab: Rituximab 375 mg/m2 on day 1 for 6 to 8 cycles

Cyclophosphamide: Cyclophosphamide 750 mg/m2 IV on day 1 for 6 to 8 cycles

Doxorubicin: Doxorubicin 50 mg/m2 on day 1 for 6 to 8 cycles

Prednisone: Prednisone 40 mg/m2 orally days 1-5, repeated every 21 days for 6 to 8 cycles.

Vincristine: Vincristine 1.4 mg/m2 (maximum = 2 mg) IV on day 1 for 6 to 8 cycles

Spots Global Cancer Trial Database for Genes in Predicting Outcome of Patients With DLBCL Treated With Rituximab and Combination Chemotherapy (R-CHOP)

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Study Description

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