Trial Outcomes & Findings for Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma (NCT NCT01369784)

Results Overview

Data will be recorded from diagnosis to second line response, an expected average of 7 months

Recruitment status

COMPLETED

Target enrollment

158 participants

Primary outcome timeframe

At diagnoses

Results posted on

2016-04-18

Participant Flow

Recruitment was carried out between April 2009 and January 2011 in Hematology Departments of 56 Spanish Hospitals

Participant milestones

Participant milestones
Measure	Refractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma) patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Study STARTED	158
Overall Study COMPLETED	146
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Refractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma) patients with refractory/relapsed diffuse large B-cell lymphoma
Overall Study Protocol Violation	12

Baseline Characteristics

Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Age, Continuous	58.4 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	68 Participants n=5 Participants
Sex: Female, Male Male	78 Participants n=5 Participants
Ann Arbor Staging I	6 participants n=5 Participants
Ann Arbor Staging II	20 participants n=5 Participants
Ann Arbor Staging III	37 participants n=5 Participants
Ann Arbor Staging IV	83 participants n=5 Participants
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 0	48 participants n=5 Participants
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 1	55 participants n=5 Participants
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 2	25 participants n=5 Participants
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 3	15 participants n=5 Participants
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status) ECOG 4	3 participants n=5 Participants

PRIMARY outcome

Timeframe: At diagnoses

Data will be recorded from diagnosis to second line response, an expected average of 7 months

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
R-IPI Index (Revised International Prognostic Index) Very good prognosis (0)	3.4 percentage of participants
R-IPI Index (Revised International Prognostic Index) Good prognosis (1,2)	32.2 percentage of participants
R-IPI Index (Revised International Prognostic Index) Poor prognosis (3,4,5)	64.4 percentage of participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
R-IPI Index (Revised International Prognostic Index) Very good prognosis (0)	9.6 percentage of patients
R-IPI Index (Revised International Prognostic Index) Good prognosis (1,2)	47.3 percentage of patients
R-IPI Index (Revised International Prognostic Index) Poor prognosis (3,4,5)	43.2 percentage of patients

PRIMARY outcome

Timeframe: At diagnosis

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=145 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Predictive Value of R-IPI at Diagnosis Global response to 2nd line + very good prognos	4 participants
Predictive Value of R-IPI at Diagnosis No global response to 2nd line + very good prognos	1 participants
Predictive Value of R-IPI at Diagnosis Global response to 2nd line + good prognosis	28 participants
Predictive Value of R-IPI at Diagnosis No global response to 2nd line + good prognosis	19 participants
Predictive Value of R-IPI at Diagnosis Global response to 2nd line + poor prognosis	56 participants
Predictive Value of R-IPI at Diagnosis No global response to 2nd line + poor prognosis	37 participants

SECONDARY outcome

Timeframe: At diagnosis

immunohistochemical reaction of cells with Bcl-2 antibody

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Bcl-2 Expression Not available	37.0 percentage of participants
Bcl-2 Expression Positive	54.1 percentage of participants
Bcl-2 Expression Negative	8.9 percentage of participants

SECONDARY outcome

Timeframe: At the beginning of the 2nd line of treatment

immunohistochemical reaction of cells with Bcl-2 antibody

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Bcl-2 Expression Positive	30 participants
Bcl-2 Expression Negative	5 participants
Bcl-2 Expression Not Available	111 participants

SECONDARY outcome

Timeframe: At diagnosis

immunohistochemical reaction of cells with Bcl-6 antibody

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Bcl-6 Expression Positive	63 participants
Bcl-6 Expression Negative	20 participants
Bcl-6 Expression Not available	63 participants

SECONDARY outcome

Timeframe: At the beginning of the second line of treatment

immunohistochemical reaction of cells with Bcl-6 antibody

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Bcl-6 Expression Not available	78.1 percentage of participants
Bcl-6 Expression Positive	14.4 percentage of participants
Bcl-6 Expression Negative	7.5 percentage of participants

SECONDARY outcome

Timeframe: At diagnosis

immunohistochemical reaction of cells with p-53 antibody

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
p-53 Expression Positive	12.3 percentage of participants
p-53 Expression Negative	10.3 percentage of participants
p-53 Expression Not available	77.4 percentage of participants

SECONDARY outcome

Timeframe: At the beginning of the 2nd line of treatment

immunohistochemical reaction of cells with p-53 antibody

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
p53 Expression Positive	5.5 percentage of participants
p53 Expression Negative	4.8 percentage of participants
p53 Expression Not available	89.7 percentage of participants

SECONDARY outcome

Timeframe: At diagnosis

immunohistochemical reaction of cells with MUM-1 antibody

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Multiple Myeloma Oncogene 1 (MUM-1) Expression Positive	16.4 percentage of participants
Multiple Myeloma Oncogene 1 (MUM-1) Expression Negative	10.3 percentage of participants
Multiple Myeloma Oncogene 1 (MUM-1) Expression Not available	73.3 percentage of participants

SECONDARY outcome

Timeframe: At the beginning of the 2nd line of treatment

immunohistochemical reaction of cells with MUM-1 antibody

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
MUM-1 Expression Positive	5.5 percentage of participants
MUM-1 Expression Negative	5.5 percentage of participants
MUM-1 Expression Not available	89.0 percentage of participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status ECOG 1	54 participants
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status ECOG 0	56 participants
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status ECOG 2	22 participants
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status ECOG 3	12 participants
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status ECOG 4	2 participants

SECONDARY outcome

Timeframe: At the beginning of the 2nd line of treatment

Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Ann Arbor Staging I	12.3 percentage of patients
Ann Arbor Staging II	21.9 percentage of patients
Ann Arbor Staging III	19.9 percentage of patients
Ann Arbor Staging IV	45.9 percentage of patients

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Refractory/Relapsed LDCBG n=146 Participants patients with refractory/relapsed diffuse large B-cell lymphoma
Response to First Line of Treatment Complete response	58 participants
Response to First Line of Treatment Uncertain complete response	5 participants
Response to First Line of Treatment Partial response	52 participants
Response to First Line of Treatment Stable disease	10 participants
Response to First Line of Treatment Progressive disease	21 participants

SECONDARY outcome

Timeframe: 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.