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TerminatedNCT01279772IELSG33Updated Mar 13, 2017

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

An observational study in Diffuse Large B-Cell Lymphoma of the Breast, sponsored by International Extranodal Lymphoma Study Group (IELSG). Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-13.

Sponsored by International Extranodal Lymphoma Study Group (IELSG) · Observational

Why this study was terminated
due to slow accrual (only 1 patient entered)
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1
Ages
18 Years and older
Sex
All
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Study summary

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.

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Conditions studied

  • Diffuse Large B-Cell Lymphoma of the Breast
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In context

Lymphoma

5,579 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 1 is below the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

International Extranodal Lymphoma Study Group (IELSG) is the lead sponsor of 29 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Previously untreated patients with localized DLBCL of the breast.

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1 participant (actual)
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What researchers measure

Primary outcomes

  1. local and CNS relapse rate

    Time frame: 12-month

Secondary outcomes

  1. progression free survival

    Time frame: 12-month

  2. overall survival

    Time frame: 5-year

  3. overall, complete and partial response rates following RCHOP

    Time frame: at the end of chemotherapy

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01279772
Lead sponsor
International Extranodal Lymphoma Study Group (IELSG)
Responsible party
Sponsor
First posted
Jan 19, 2011
Start date
Oct 2011
Last update
Mar 13, 2017

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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