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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Observational
Study Design Observational Model: Case-Only;   Time Perspective: Cross-Sectional
Condition Diffuse Large B-cell Lymphoma
Enrollment 158
Recruitment Details Recruitment was carried out between April 2009 and January 2011 in Hematology Departments of 56 Spanish Hospitals
Pre-assignment Details  
Arm/Group Title Refractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma)
Hide Arm/Group Description patients with refractory/relapsed diffuse large B-cell lymphoma
Period Title: Overall Study
Started 158
Completed 146
Not Completed 12
Reason Not Completed
Protocol Violation             12
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Baseline Participants 146
Hide Baseline Analysis Population Description
12 patients were not included in the data analysis for not fulfilling selection criteria
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 146 participants
58.4  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 146 participants
Female
68
  46.6%
Male
78
  53.4%
Ann Arbor Staging   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
I 6
II 20
III 37
IV 83
[1]
Measure Description: Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status)   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 146 participants
ECOG 0 48
ECOG 1 55
ECOG 2 25
ECOG 3 15
ECOG 4 3
[1]
Measure Description: ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus
1.Primary Outcome
Title R-IPI Index (Revised International Prognostic Index)
Hide Description Data will be recorded from diagnosis to second line response, an expected average of 7 months
Time Frame At diagnoses
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
Very good prognosis (0) 3.4
Good prognosis (1,2) 32.2
Poor prognosis (3,4,5) 64.4
2.Primary Outcome
Title R-IPI Index (Revised International Prognostic Index)
Hide Description 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.
Time Frame At the beginning of the 2nd line of treatment, an average of 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of patients
Very good prognosis (0) 9.6
Good prognosis (1,2) 47.3
Poor prognosis (3,4,5) 43.2
3.Primary Outcome
Title Predictive Value of R-IPI at Diagnosis
Hide Description [Not Specified]
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 145
Measure Type: Number
Unit of Measure: participants
Global response to 2nd line + very good prognos 4
No global response to 2nd line + very good prognos 1
Global response to 2nd line + good prognosis 28
No global response to 2nd line + good prognosis 19
Global response to 2nd line + poor prognosis 56
No global response to 2nd line + poor prognosis 37
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Refractory/Relapsed LDCBG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.812
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
4.Secondary Outcome
Title Bcl-2 Expression
Hide Description immunohistochemical reaction of cells with Bcl-2 antibody
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
Positive 54.1
Negative 8.9
Not available 37.0
5.Secondary Outcome
Title Bcl-2 Expression
Hide Description immunohistochemical reaction of cells with Bcl-2 antibody
Time Frame At the beginning of the 2nd line of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
Positive 30
Negative 5
Not Available 111
6.Secondary Outcome
Title Bcl-6 Expression
Hide Description immunohistochemical reaction of cells with Bcl-6 antibody
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
Positive 63
Negative 20
Not available 63
7.Secondary Outcome
Title Bcl-6 Expression
Hide Description immunohistochemical reaction of cells with Bcl-6 antibody
Time Frame At the beginning of the second line of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
Positive 14.4
Negative 7.5
Not available 78.1
8.Secondary Outcome
Title p-53 Expression
Hide Description immunohistochemical reaction of cells with p-53 antibody
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
Positive 12.3
Negative 10.3
Not available 77.4
9.Secondary Outcome
Title p53 Expression
Hide Description immunohistochemical reaction of cells with p-53 antibody
Time Frame At the beginning of the 2nd line of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
Positive 5.5
Negative 4.8
Not available 89.7
10.Secondary Outcome
Title Multiple Myeloma Oncogene 1 (MUM-1) Expression
Hide Description immunohistochemical reaction of cells with MUM-1 antibody
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
Positive 16.4
Negative 10.3
Not available 73.3
11.Secondary Outcome
Title MUM-1 Expression
Hide Description immunohistochemical reaction of cells with MUM-1 antibody
Time Frame At the beginning of the 2nd line of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of participants
Positive 5.5
Negative 5.5
Not available 89.0
12.Secondary Outcome
Title Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status
Hide Description ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus
Time Frame At the beginning of the 2nd line of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
ECOG 0 56
ECOG 1 54
ECOG 2 22
ECOG 3 12
ECOG 4 2
13.Secondary Outcome
Title Ann Arbor Staging
Hide Description Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition
Time Frame At the beginning of the 2nd line of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: percentage of patients
I 12.3
II 21.9
III 19.9
IV 45.9
14.Secondary Outcome
Title Response to First Line of Treatment
Hide Description

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.

Time Frame After first line treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 146
Measure Type: Number
Unit of Measure: participants
Complete response 58
Uncertain complete response 5
Partial response 52
Stable disease 10
Progressive disease 21
15.Secondary Outcome
Title Response to Second Line of Treatment
Hide Description

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.

Time Frame After second line of treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 145
Measure Type: Number
Unit of Measure: participants
Complete response 46
Uncertain complete response 15
Partial response 27
Stable disease 9
Progressive disease 38
Not evaluated 10
16.Secondary Outcome
Title Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis
Hide Description 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
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 145
Measure Type: Number
Unit of Measure: participants
Global response to 2nd line + Bcl-2 + 50
Global response to 2nd line + Bcl-2 - 8
No global response to 2nd line + Bcl-2 + 28
No global response to 2nd line + Bcl-2 - 5
Global response to 2nd line +Bcl-2 ND 30
No global response to 2nd line + Bcl-2 ND 24
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Refractory/Relapsed LDCBG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.612
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
17.Secondary Outcome
Title Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis
Hide Description 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
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 145
Measure Type: Number
Unit of Measure: participants
Global response to 2nd line + Bcl-6 + 34
Global response to 2nd line + Bcl-6 - 14
Global response to 2nd line + Blc-6 ND 40
No global response to 2nd line + Bcl-6 + 28
No global response to 2nd line + Bcl-6 - 6
No global response to 2nd line + Bcl-6 ND 23
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Refractory/Relapsed LDCBG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.402
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
18.Secondary Outcome
Title Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis
Hide Description 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
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 145
Measure Type: Number
Unit of Measure: participants
Global response to 2nd line + p53+ 13
Global response to 2nd line + p53- 8
No global response to 2nd line + p53+ 5
No global response to 2nd line + p53- 6
Global response to 2nd line + p53 ND 67
Global response to 2nd line + p53 - ND 46
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Refractory/Relapsed LDCBG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.557
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
19.Secondary Outcome
Title Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis
Hide Description 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
Time Frame At diagnosis
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 145
Measure Type: Number
Unit of Measure: participants
Global response to 2nd line + MUM1 + 17
Global response to 2nd line + MUM1 - 6
No global response to 2nd line + MUM1 + 7
No global response to 2nd line + MUM1 - 8
Global response to 2nd line + MUM1 ND 65
No global response to 2nd line + MUM1 ND 42
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Refractory/Relapsed LDCBG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.234
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
20.Post-Hoc Outcome
Title Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse
Hide Description 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
Time Frame At relapse
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 142
Measure Type: Number
Unit of Measure: participants
Global response to 2nd line + lymphocyte <1 40
Global response to 2nd line + lymphocyte >=1 47
No global response to 2nd line + lymphocyte <1 35
No global response to 2nd line + lymphocyte >=1 20
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Refractory/Relapsed LDCBG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.057
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
21.Post-Hoc Outcome
Title Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse
Hide Description 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
Time Frame At relapse
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 141
Measure Type: Number
Unit of Measure: participants
Global response to 2nd line + ratio <=2.6 46
Global response to 2nd line + ratio >2.6 40
No global response to 2nd line + ratio <=2.6 37
No global response to 2nd line + ratio >2.6 18
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Refractory/Relapsed LDCBG
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.117
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
22.Post-Hoc Outcome
Title Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse
Hide Description 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
Time Frame At relapse
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description:
patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Number of Participants Analyzed 88
Mean (Standard Deviation)
Unit of Measure: mg/100ml
Global response to 2nd line 2.47  (1.51)
No global response to 2nd line 2.41  (1.51)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Refractory/Relapsed LDCBG
Hide Arm/Group Description patients with refractory/relapsed diffuse large B-cell lymphoma
All-Cause Mortality
Refractory/Relapsed LDCBG
Affected / at Risk (%)
Total   --/-- 
Hide Serious Adverse Events
Refractory/Relapsed LDCBG
Affected / at Risk (%)
Total   18/146 (12.33%) 
Blood and lymphatic system disorders   
Neutropenia  7/146 (4.79%) 
Leucopenia  6/146 (4.11%) 
Trombocitopenia  4/146 (2.74%) 
Anemia  1/146 (0.68%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Refractory/Relapsed LDCBG
Affected / at Risk (%)
Total   44/146 (30.14%) 
Gastrointestinal disorders   
Gastrointestinal symptoms  18/146 (12.33%) 
General disorders   
Fatigue  17/146 (11.64%) 
Metabolism and nutrition disorders   
Anorexia  9/146 (6.16%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Carlos Panizo
Organization: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea (GELTAMO)
Phone: + 34 948 25 54 00
EMail: cpanizo@unav.es
Layout table for additonal information
Responsible Party: Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
ClinicalTrials.gov Identifier: NCT01369784    
Other Study ID Numbers: PRO-R-IPI
First Submitted: February 23, 2011
First Posted: June 9, 2011
Results First Submitted: July 21, 2014
Results First Posted: April 18, 2016
Last Update Posted: April 18, 2016