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This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas (IELSG33)

This study has been terminated.
(due to slow accrual (only 1 patient entered))
Sponsor:
Information provided by (Responsible Party):
International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier:
NCT01279772
First received: January 18, 2011
Last updated: July 6, 2012
Last verified: July 2012
  Purpose

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.


Condition
Diffuse Large B Cell Lymphoma of the Breast.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With R-CHOP With or Without Radiotherapy

Resource links provided by NLM:


Further study details as provided by International Extranodal Lymphoma Study Group (IELSG):

Primary Outcome Measures:
  • local and CNS relapse rate

Secondary Outcome Measures:
  • progression free survival [ Time Frame: 12-month ]
  • overall survival [ Time Frame: 5-year ]
  • overall, complete and partial response rates following RCHOP [ Time Frame: at the end of chemotherapy ]

Enrollment: 1
Study Start Date: October 2011
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Previously untreated patients with localized DLBCL of the breast.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: International Extranodal Lymphoma Study Group (IELSG)
ClinicalTrials.gov Identifier: NCT01279772     History of Changes
Other Study ID Numbers: IELSG33
Study First Received: January 18, 2011
Last Updated: July 6, 2012
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on November 24, 2014