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 (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier:
NCT01369784
First received: February 23, 2011
Last updated: March 17, 2016
Last verified: March 2016
  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:


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

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

  • R-IPI Index (Revised International Prognostic Index) [ Time Frame: At the beginning of the 2nd line of treatment, an average of 2 years ] [ Designated as safety issue: No ]
    The IPI is based on the evaluation of 5 clinical factors: age > 60 years Ann Arbor stage III or IV disease > 1 extra nodal site European Cooperative Oncology Group performance status (ECOG PS) _ 2, increased serum LDH (lactate dehydrogenase) levels Revised IPI (R-IPI) evaluates the same parameters, but groups them differently to form 3 prognostic groups of patients with significantly different progression-free survival and overall survival outcomes.

  • Predictive Value of R-IPI at Diagnosis [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Bcl-2 Expression [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    immunohistochemical reaction of cells with Bcl-2 antibody

  • Bcl-2 Expression [ Time Frame: At the beginning of the 2nd line of treatment ] [ Designated as safety issue: No ]
    immunohistochemical reaction of cells with Bcl-2 antibody

  • Bcl-6 Expression [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    immunohistochemical reaction of cells with Bcl-6 antibody

  • Bcl-6 Expression [ Time Frame: At the beginning of the second line of treatment ] [ Designated as safety issue: No ]
    immunohistochemical reaction of cells with Bcl-6 antibody

  • p-53 Expression [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    immunohistochemical reaction of cells with p-53 antibody

  • p53 Expression [ Time Frame: At the beginning of the 2nd line of treatment ] [ Designated as safety issue: No ]
    immunohistochemical reaction of cells with p-53 antibody

  • Multiple Myeloma Oncogene 1 (MUM-1) Expression [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    immunohistochemical reaction of cells with MUM-1 antibody

  • MUM-1 Expression [ Time Frame: At the beginning of the 2nd line of treatment ] [ Designated as safety issue: No ]
    immunohistochemical reaction of cells with MUM-1 antibody

  • Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status [ Time Frame: At the beginning of the 2nd line of treatment ] [ Designated as safety issue: No ]
    ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus

  • Ann Arbor Staging [ Time Frame: At the beginning of the 2nd line of treatment ] [ Designated as safety issue: No ]
    Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition

  • Response to First Line of Treatment [ Time Frame: After first line treatment ] [ Designated as safety issue: No ]

    Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.

    Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.


  • Response to Second Line of Treatment [ Time Frame: After second line of treatment ] [ Designated as safety issue: No ]

    Complete Response (CR), Disappearance of all target lesions for at least 8 weeks.

    Partial response (PR): At least a 50% dicrease in the sum of the products of two measurements (the maximum diameter of a tumor and the largest diameter perpendicular to this maximum diameter) of 6 biggest individual tumors. Not increased of measure of other tumors, spleen or liver Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum LD since the treatment started Progressive Disease (PD): At least a 50% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions during or at the end of the treatment.


  • Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse

  • Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse

  • Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse

  • Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis [ Time Frame: At diagnosis ] [ Designated as safety issue: No ]
    Global response rate was assessed using the National Cancer Institute-sponsored Working Group guidelines. Responses are: complete response, partial response, stable disease, progression and relapse


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   (Adult, Senior)
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
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.

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

Responsible Party: 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
Results First Received: July 21, 2014
Last Updated: March 17, 2016
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 August 25, 2016