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Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma (PRO-R-IPI)

This study has been completed.
Sponsor:
Information provided by:
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01369784
First received: February 23, 2011
Last updated: June 8, 2011
Last verified: June 2011
History of Changes
  Purpose

The purpose of this study is to evaluate the prognostic value of clinical and biological factors in patients with refractory/relapsed Diffuse Large B-Cell Lymphoma.


Condition
Diffuse Large B-cell Lymphoma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: Observational, Post-authorization, Cross-sectional Study to Evaluate the Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma

Resource links provided by NLM:

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

Further study details as provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:

Primary Outcome Measures:
  • R-IPI Index [ Time Frame: Average of 7 months ] [ Designated as safety issue: No ]
    Data will be recorded from diagnosis to second line response, an expected average of 7 months


Enrollment: 158
Study Start Date: February 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
refractory/relapsed LDCBG
patients with refractory/relapsed diffuse large B-cell lymphoma

Detailed Description:

The main aim of this study is to compare the prognostic value of R-IPI at diagnosis and relapse, relating it with the obtained response after second line

  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

Patients with refractory/relapsed diffuse large B-cell lymphoma

Criteria
  • Age 18 > years old
  • Patients with refractory/relapsed diffuse large B-cell lymphoma after first line treatment with rituximab, with or without transplantation. Patients must have finished a rescue treatment including rituximab
  • Ability to understand and willingness to sign a written informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01369784

  Show 56 Study Locations
Sponsors and Collaborators
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Investigators
Study Chair: Carlos Panizo, PhD Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea
  More Information

No publications provided

Responsible Party: Carlos Panizo, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT01369784     History of Changes
Other Study ID Numbers: PRO-R-IPI
Study First Received: February 23, 2011
Last Updated: June 8, 2011
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea:
Diffuse large B-cell Lymphoma
R-IPI

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

ClinicalTrials.gov processed this record on June 17, 2013