Lymphoma, Non-Hodgkin Clinical Trial
Official title:
Phase II Trial of CHOP-Rituximab Augmented With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in Patients With Previously Untreated Diffuse Large B Cell Non-Hodgkin's Lymphoma
Verified date | January 2018 |
Source | Massachusetts General Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The primary goal of this study is to determine the effects (good and bad) of Granulocyte-macrophage colony stimulating factor (GM-CSF) in combination with Cytoxan, Adriamycin, Vincristine, Prednisone, Rituximab (CHOP-R) on diffuse Large B cell Non-Hodgkin's lymphoma (DLBCL). The standard of care for DLBCL is the combination of drugs known as CHOP-Rituximab (CHOP-R). The drugs that make up CHOP-R are the chemotherapy drugs cyclophosphamide, doxorubicin and vincristine, prednisone and rituximab. GM-CSF is a drug that stimulates the immune system by increasing the numbers of white blood cells. Previous research has shown that GM-CSF might help rituximab to be more effective in treating lymphoma.
Status | Terminated |
Enrollment | 3 |
Est. completion date | July 2011 |
Est. primary completion date | November 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Histologically confirmed diagnosis of diffuse large B cell Non-Hodgkin's lymphoma with characteristic immunophenotypic profile - Patient has not received any prior anti-cancer therapy for lymphoma - Tumor tissue confirmed to express the cluster of differentiation antigen 20 antigen by flow cytometry or immunohistochemistry - Measurable disease as defined by a tumor mass of 1cm or greater in one dimension - Stage II (abdominal-not radiotherapy appropriate), III, or IV disease - Age > 18 years - Performance Status of 0-2 - Laboratory parameters as outlined in protocol - Patient agrees to use birth control Exclusion Criteria: - Known central nervous system involvement by lymphoma - Serious uncontrolled concurrent illness such as active coronary artery disease, severe lung disease, heart failure, active alcohol abuse, active concurrent malignancy except non-melanoma skin cancer or carcinoma in situ of the cervix - Any evidence of prior natural exposure to Hepatitis B - Active rheumatologic disease which may be exacerbated by GM-CSF - Cardiac ejection fraction less than 45% - Known HIV disease - Patient is pregnant or nursing - Patient is receiving other investigational drugs |
Country | Name | City | State |
---|---|---|---|
United States | Beth Israel Deaconess Medical Center | Boston | Massachusetts |
United States | Dana-Farber Cancer Institute | Boston | Massachusetts |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Massachusetts General Hospital | Bayer, Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Dana-Farber Cancer Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the safety of GM-CSF when administered in combination with CHOP-R to patients with previously untreated diffuse large B cell non-Hodgkin's lymphoma. | 2 years | ||
Secondary | To assess the response rate, 2-year event-free survival and overall survival with CM-CSF and CHOP-R in this patient population | |||
Secondary | to analyze the biologic activity of GM-CSF at this dosing schedule and timing. | 2 years |
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