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

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ClinicalTrials.gov Identifier: NCT01369784
Recruitment Status : Completed
First Posted : June 9, 2011
Results First Posted : April 18, 2016
Last Update Posted : April 18, 2016
Sponsor:
Information provided by (Responsible Party):
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea

Tracking Information
First Submitted Date February 23, 2011
First Posted Date June 9, 2011
Results First Submitted Date July 21, 2014
Results First Posted Date April 18, 2016
Last Update Posted Date April 18, 2016
Study Start Date February 2009
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 17, 2016)
  • R-IPI Index (Revised International Prognostic Index) [ Time Frame: At diagnoses ]
    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 ]
    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 ]
Original Primary Outcome Measures
 (submitted: June 8, 2011)
R-IPI Index [ Time Frame: Average of 7 months ]
Data will be recorded from diagnosis to second line response, an expected average of 7 months
Change History
Current Secondary Outcome Measures
 (submitted: March 17, 2016)
  • Bcl-2 Expression [ Time Frame: At diagnosis ]
    immunohistochemical reaction of cells with Bcl-2 antibody
  • Bcl-2 Expression [ Time Frame: At the beginning of the 2nd line of treatment ]
    immunohistochemical reaction of cells with Bcl-2 antibody
  • Bcl-6 Expression [ Time Frame: At diagnosis ]
    immunohistochemical reaction of cells with Bcl-6 antibody
  • Bcl-6 Expression [ Time Frame: At the beginning of the second line of treatment ]
    immunohistochemical reaction of cells with Bcl-6 antibody
  • p-53 Expression [ Time Frame: At diagnosis ]
    immunohistochemical reaction of cells with p-53 antibody
  • p53 Expression [ Time Frame: At the beginning of the 2nd line of treatment ]
    immunohistochemical reaction of cells with p-53 antibody
  • Multiple Myeloma Oncogene 1 (MUM-1) Expression [ Time Frame: At diagnosis ]
    immunohistochemical reaction of cells with MUM-1 antibody
  • MUM-1 Expression [ Time Frame: At the beginning of the 2nd line of treatment ]
    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 ]
    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 ]
    Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition
  • Response to First Line of Treatment [ Time Frame: After first line treatment ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma
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
Brief Summary 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.
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
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with refractory/relapsed diffuse large B-cell lymphoma
Condition Diffuse Large B-cell Lymphoma
Intervention Not Provided
Study Groups/Cohorts refractory/relapsed LDCBG
patients with refractory/relapsed diffuse large B-cell lymphoma
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 8, 2011)
158
Original Actual Enrollment Same as current
Actual Study Completion Date March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT01369784
Other Study ID Numbers PRO-R-IPI
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Study Sponsor Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Collaborators Not Provided
Investigators
Study Chair: Carlos Panizo, PhD Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea
PRS Account Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Verification Date March 2016