Diffuse Large B-cell LymphomaPRO-R-IPINCT01369784
Prognostic Value of Clinical and Biological Factors in Patients With Refractory/Relapsed Diffuse Large B-cell Lymphoma
An observational study of Diffuse Large B-cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 56 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diffuse Large B-cell Lymphoma
- How many people
- 158 participants
- Where
- 56 sitesSpain
- Study dates
- Feb 2009to Mar 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with refractory/relapsed diffuse large B-cell lymphoma
- 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
Trial locations and contacts
56 sites in 1 country.
56 sites in 1 country
Spain56 sites
C.H.U. A Coruña
A Coruña, La Coruña
H.U. Fundación Alcorcón
Alcorcón, Madrid
H. Nuestra Señora de Sonsoles
Ávila, Ávila
H. U. Germans Trias i Pujol
Badalona, Barcelona
Hospital Clinic i Provincial
Barcelona, Barcelona
Hospital del Mar
Barcelona, Barcelona
Hospital Vall D'Hebrón
Barcelona, Barcelona
H. Basurto
Bilbao, Vizcaya
Hospital de Elda
Elda, Alicante
H.U.de Getafe
Getafe, Madrid
Hospital de Cabueñes
Gijón, Principality of Asturias
Institut Catalá d'Oncologia de Girona
Girona, Gerona
H.U. Virgen de las Nieves
Granada, Granada
Hospital General de Granollers
Granollers, Barcelona
Complejo Hospitalario de Jaén
Jaén, Jaén
Hospital General del SAS de Jerez
Jerez de la Frontera, Cádiz
ICO-DYR
L'Hospitalet de Llobregat, Barcelona
H. Severo Ochoa
Leganés, Madrid
Hospital de León
León, León
Hospital Universitario Arnau de Vilanova
Lleida, Lérida
Hospital San Pedro
Logroño, La Rioja
Hospital Xeral
Lugo, Lugo
H. Ramón y Cajal
Madrid, Madrid
H. U. La Princesa
Madrid, Madrid
H.G.U. Gregorio Marañón
Madrid, Madrid
H.U. La Paz
Madrid, Madrid
Hospital 12 de Octubre
Madrid, Madrid
MD Anderson
Madrid, Madrid
H. Carlos Haya
Málaga, Málaga
Hospital Son Llatzer
Mallorca, Mallorca
Althaia
Manresa, Barcelona
Hospital Costa del Sol
Marbella, Málaga
Hospital de Mataró
Mataró, Barcelona
H.U. Virgen de la Arrixaca
Murcia, Murcia
Hospital Morales Messeguer
Murcia, Murcia
Complexo Hospitalario de Ourense
Ourense, Orense
H. U. Central de Asturias
Oviedo, Principality of Asturias
Hospital Universitario Son Dureta
Palma de Mallorca, Palma de Mallorca
Clínica Universitaria de Navarra
Pamplona, Navarre
Hospital de Navarra
Pamplona, Navarre
Hospital Parc Taulí
Sabadell, Barcelona
H. Universitario de Salamanca
Salamanca, Salamanca
H. Universitario de Canarias
San Cristóbal de La Laguna, Tenerife
Hospital Galdakao
San Sebastián, Guipuzcoa
H. Clínico U. Santiago de Compostela
Santiago de Compostela, La Coruña
H. General de Segovia
Segovia, Segovia
H.U. Nuestra Señora de Valme
Seville, Sevilla
H. Nuestra Señora del Prado
Talavera de la Reina, Toledo
H. Sierrallana
Torrelavega, Cantabria
H. Arnau de Vilanova
Valencia, Valencia
H. Clínico de Valencia
Valencia, Valencia
H. Dr. Peset
Valencia, Valencia
H. Río Hortega
Valladolid, Valladolid
Hospital Clínico Universitario Valladolid
Valladolid, Valladolid
H. Txagorritxu
Vitoria-Gasteiz, Álava
H. Virgen de La Concha
Zamora, Zamora
About this study
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
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.
Read the 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
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Diffuse large B-cell Lymphoma, R-IPI
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| refractory/relapsed LDCBG | patients with refractory/relapsed diffuse large B-cell lymphoma |
What is being measured
The primary outcome is the main question the study is designed to answer.
R-IPI Index (Revised International Prognostic Index)
Data will be recorded from diagnosis to second line response, an expected average of 7 months
Measured: At diagnoses
R-IPI Index (Revised International Prognostic Index)
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.
Measured: At the beginning of the 2nd line of treatment, an average of 2 years
Predictive Value of R-IPI at Diagnosis
Measured: At diagnosis
Secondary outcomes (16)
Bcl-2 Expression
immunohistochemical reaction of cells with Bcl-2 antibody
Measured: At diagnosis
Bcl-2 Expression
immunohistochemical reaction of cells with Bcl-2 antibody
Measured: At the beginning of the 2nd line of treatment
Bcl-6 Expression
immunohistochemical reaction of cells with Bcl-6 antibody
Measured: At diagnosis
Bcl-6 Expression
immunohistochemical reaction of cells with Bcl-6 antibody
Measured: At the beginning of the second line of treatment
p-53 Expression
immunohistochemical reaction of cells with p-53 antibody
Measured: At diagnosis
p53 Expression
immunohistochemical reaction of cells with p-53 antibody
Measured: At the beginning of the 2nd line of treatment
Multiple Myeloma Oncogene 1 (MUM-1) Expression
immunohistochemical reaction of cells with MUM-1 antibody
Measured: At diagnosis
MUM-1 Expression
immunohistochemical reaction of cells with MUM-1 antibody
Measured: At the beginning of the 2nd line of treatment
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status
ECOG=0: Fully active, able to carry on all pre-disease performance without restriction ECOG=5: Exitus
Measured: At the beginning of the 2nd line of treatment
Ann Arbor Staging
Ann Arbor=I: Best condition Ann Arbor=IV: Worst condition
Measured: At the beginning of the 2nd line of treatment
Response to First 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.
Measured: After first line treatment
Response to 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.
Measured: After second line of treatment
Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression 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
Measured: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression 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
Measured: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression 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
Measured: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression 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
Measured: At diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2011 (estimated)
- Study startFeb 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Large B-cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carlos Panizo, PhD, Study chair, Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01369784
- Sponsor's protocol ID
- PRO-R-IPI
- Acronym
- PRO-R-IPI
- Status last verified
- Mar 2016
- First submitted
- 23 Feb 2011
- Last updated
- 18 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01369784
- Acronym / sponsor ID
- PRO-R-IPI / PRO-R-IPI
- Conditions
- Diffuse Large B-cell Lymphoma
- Keywords
- Diffuse large B-cell Lymphoma, R-IPI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Jun 2011 (estimated)
- Results
- Posted 18 Apr 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| refractory/relapsed LDCBG | – | –patients with refractory/relapsed diffuse large B-cell lymphoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with refractory/relapsed diffuse large B-cell lymphoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
16 secondary outcomes
Bcl-2 Expression
Time frame: At diagnosis
Bcl-2 Expression
Time frame: At the beginning of the 2nd line of treatment
Bcl-6 Expression
Time frame: At diagnosis
Bcl-6 Expression
Time frame: At the beginning of the second line of treatment
p-53 Expression
Time frame: At diagnosis
p53 Expression
Time frame: At the beginning of the 2nd line of treatment
Multiple Myeloma Oncogene 1 (MUM-1) Expression
Time frame: At diagnosis
MUM-1 Expression
Time frame: At the beginning of the 2nd line of treatment
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status
Time frame: At the beginning of the 2nd line of treatment
Ann Arbor Staging
Time frame: At the beginning of the 2nd line of treatment
Response to First Line of Treatment
Time frame: After first line treatment
Response to Second Line of Treatment
Time frame: After second line of treatment
Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis
Time frame: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis
Time frame: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis
Time frame: At diagnosis
Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis
Time frame: At diagnosis
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Diffuse Large B-cell Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
Not yet recruitingPhase 2
The CARDIOPROTECT Trial
Diffuse Large B-cell Lymphoma (DLBCL), Cardiotoxicity
Not yet recruitingPhase 2
QLS4131 Plus Isa-V-CHOP in Newly Diagnosed, HIV-Negative PBL: A Single-Center, Single-Arm, Phase II Study
Plasmablastic Lymphoma
RecruitingPhase 2
Testing the Effectiveness of a Combination Targeted Therapy (ViPOR) for Patients With Relapsed and/or Refractory Aggressive B-cell Lymphoma
High Grade B-Cell Lymphoma With MYC and BCL6 Rearrangements, Recurrent Diffuse Large B-Cell Lymphoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos Panizo, PhD study chair
Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea
56 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diffuse Large B-cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 56 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
R-IPI Index (Revised International Prognostic Index) (time frame: At diagnoses). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.