Diffuse Large B-Cell Lymphoma of the Breast Clinical Trial
— IELSG33Official title:
A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With R-CHOP With or Without Radiotherapy
| NCT number | NCT01279772 |
| Other study ID # | IELSG33 |
| Secondary ID | |
| Status | Terminated |
| Phase | N/A |
| First received | January 18, 2011 |
| Last updated | March 10, 2017 |
| Start date | October 2011 |
| Verified date | July 2012 |
| Source | International Extranodal Lymphoma Study Group (IELSG) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
In this study, the investigators propose that the addition of rituximab will lower the risk of systemic and local relapses in patients with localized PBL. Patients will be treated with 6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy is strongly recommended, based on the findings of the retrospective IELSG study, but will be at the discretion of the treating center.
| Status | Terminated |
| Enrollment | 1 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Previously untreated patients with DLBCL of the breast. - Patients must have CD20 positive tumors. - Stage IE or IIE. - Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study. - Patients must have an ECOG performance status 0-2. - Patients must have adequate organ function as evidenced by the following laboratory studies ( within 2 weeks prior to registration): - Creatinine Clearance > 50 ml/min - Total bilirubin < 2.0 mg/dl and AST < 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be < 3 x ULN, and AST < 5 x ULN. - Absolute neutrophil count > 1500/mm3 and platelet count > 100,000/mm3. If documented bone marrow involvement with lymphoma, absolute neutrophil count > 500/mm3 and platelet count > 50,000/mm3. - Patients must be age > 18 years. - Patients must have a normal left ventricular ejection fraction to be eligible. Exclusion Criteria: - historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement. - pregnant or breast feeding patients. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception. - active infection requiring parental antibiotics. - known HIV infection |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| International Extranodal Lymphoma Study Group (IELSG) |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | local and CNS relapse rate | 12-month | ||
| Secondary | progression free survival | 12-month | ||
| Secondary | overall survival | 5-year | ||
| Secondary | overall, complete and partial response rates following RCHOP | at the end of chemotherapy |