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CompletedNCT01369784PRO-R-IPIUpdated Apr 18, 2016Results posted

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

An observational study in Diffuse Large B-cell Lymphoma, sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea. Completed at 56 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-04-18.

Sponsored by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
158
Ages
18 Years and older
Sex
All
01

Study 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 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

02

Conditions studied

  • Diffuse Large B-cell Lymphoma

Keywords

  • Diffuse large B-cell Lymphoma
  • R-IPI
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 158 is above the median of 136 across 625 observational studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea is the lead sponsor of 25 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with refractory/relapsed diffuse large B-cell lymphoma

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
05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
158 participants (actual)
Patient registry
No

Groups and cohorts

  • refractory/relapsed LDCBG

    patients with refractory/relapsed diffuse large B-cell lymphoma

06

What researchers measure

Primary outcomes

  1. R-IPI Index (Revised International Prognostic Index)

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

    Time frame: At diagnoses

  2. 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.

    Time frame: At the beginning of the 2nd line of treatment, an average of 2 years

  3. Predictive Value of R-IPI at Diagnosis

    Time frame: At diagnosis

Secondary outcomes

  1. Bcl-2 Expression

    immunohistochemical reaction of cells with Bcl-2 antibody

    Time frame: At diagnosis

  2. Bcl-2 Expression

    immunohistochemical reaction of cells with Bcl-2 antibody

    Time frame: At the beginning of the 2nd line of treatment

  3. Bcl-6 Expression

    immunohistochemical reaction of cells with Bcl-6 antibody

    Time frame: At diagnosis

  4. Bcl-6 Expression

    immunohistochemical reaction of cells with Bcl-6 antibody

    Time frame: At the beginning of the second line of treatment

  5. p-53 Expression

    immunohistochemical reaction of cells with p-53 antibody

    Time frame: At diagnosis

  6. p53 Expression

    immunohistochemical reaction of cells with p-53 antibody

    Time frame: At the beginning of the 2nd line of treatment

  7. Multiple Myeloma Oncogene 1 (MUM-1) Expression

    immunohistochemical reaction of cells with MUM-1 antibody

    Time frame: At diagnosis

  8. MUM-1 Expression

    immunohistochemical reaction of cells with MUM-1 antibody

    Time frame: At the beginning of the 2nd line of treatment

  9. 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

    Time frame: At the beginning of the 2nd line of treatment

  10. Ann Arbor Staging

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

    Time frame: At the beginning of the 2nd line of treatment

  11. 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.

    Time frame: After first line treatment

  12. 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.

    Time frame: After second line of treatment

  13. 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

    Time frame: At diagnosis

  14. 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

    Time frame: At diagnosis

  15. 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

    Time frame: At diagnosis

  16. 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

    Time frame: At diagnosis

07

Results

Posted Apr 18, 2016

Participant flow

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

Participant flow — Overall Study
MilestoneRefractory/Relapsed LDCBG (Diffuse Large-B-cell Lymphoma)
Started158
Completed146
Not completed12
Withdrew: Protocol violation12

Outcome measures

PrimaryR-IPI Index (Revised International Prognostic Index)

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

Time frame:
At diagnoses
Reported as:
Number · percentage of participants
R-IPI Index (Revised International Prognostic Index)
percentage of participantsRefractory/Relapsed LDCBG
Very good prognosis (0)3.4
Good prognosis (1,2)32.2
Poor prognosis (3,4,5)64.4
SecondaryBcl-2 Expression

immunohistochemical reaction of cells with Bcl-2 antibody

Time frame:
At diagnosis
Reported as:
Number · percentage of participants
Bcl-2 Expression
percentage of participantsRefractory/Relapsed LDCBG
Positive54.1
Negative8.9
Not available37.0
SecondaryBcl-2 Expression

immunohistochemical reaction of cells with Bcl-2 antibody

Time frame:
At the beginning of the 2nd line of treatment
Reported as:
Number · participants
Bcl-2 Expression
participantsRefractory/Relapsed LDCBG
Positive30
Negative5
Not Available111
SecondaryBcl-6 Expression

immunohistochemical reaction of cells with Bcl-6 antibody

Time frame:
At diagnosis
Reported as:
Number · participants
Bcl-6 Expression
participantsRefractory/Relapsed LDCBG
Positive63
Negative20
Not available63
SecondaryBcl-6 Expression

immunohistochemical reaction of cells with Bcl-6 antibody

Time frame:
At the beginning of the second line of treatment
Reported as:
Number · percentage of participants
Bcl-6 Expression
percentage of participantsRefractory/Relapsed LDCBG
Positive14.4
Negative7.5
Not available78.1
PrimaryR-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.

Time frame:
At the beginning of the 2nd line of treatment, an average of 2 years
Reported as:
Number · percentage of patients
R-IPI Index (Revised International Prognostic Index)
percentage of patientsRefractory/Relapsed LDCBG
Very good prognosis (0)9.6
Good prognosis (1,2)47.3
Poor prognosis (3,4,5)43.2
Secondaryp-53 Expression

immunohistochemical reaction of cells with p-53 antibody

Time frame:
At diagnosis
Reported as:
Number · percentage of participants
p-53 Expression
percentage of participantsRefractory/Relapsed LDCBG
Positive12.3
Negative10.3
Not available77.4
Secondaryp53 Expression

immunohistochemical reaction of cells with p-53 antibody

Time frame:
At the beginning of the 2nd line of treatment
Reported as:
Number · percentage of participants
p53 Expression
percentage of participantsRefractory/Relapsed LDCBG
Positive5.5
Negative4.8
Not available89.7
SecondaryMultiple Myeloma Oncogene 1 (MUM-1) Expression

immunohistochemical reaction of cells with MUM-1 antibody

Time frame:
At diagnosis
Reported as:
Number · percentage of participants
Multiple Myeloma Oncogene 1 (MUM-1) Expression
percentage of participantsRefractory/Relapsed LDCBG
Positive16.4
Negative10.3
Not available73.3
SecondaryMUM-1 Expression

immunohistochemical reaction of cells with MUM-1 antibody

Time frame:
At the beginning of the 2nd line of treatment
Reported as:
Number · percentage of participants
MUM-1 Expression
percentage of participantsRefractory/Relapsed LDCBG
Positive5.5
Negative5.5
Not available89.0
SecondaryEastern 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

Time frame:
At the beginning of the 2nd line of treatment
Reported as:
Number · participants
Eastern Cooperative Oncology Group Performance Status (ECOG) Performance Status
participantsRefractory/Relapsed LDCBG
ECOG 056
ECOG 154
ECOG 222
ECOG 312
ECOG 42
SecondaryAnn Arbor Staging

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

Time frame:
At the beginning of the 2nd line of treatment
Reported as:
Number · percentage of patients
Ann Arbor Staging
percentage of patientsRefractory/Relapsed LDCBG
I12.3
II21.9
III19.9
IV45.9
SecondaryResponse 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.

Time frame:
After first line treatment
Reported as:
Number · participants
Response to First Line of Treatment
participantsRefractory/Relapsed LDCBG
Complete response58
Uncertain complete response5
Partial response52
Stable disease10
Progressive disease21
SecondaryResponse 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.

Time frame:
After second line of treatment
Reported as:
Number · participants
Response to Second Line of Treatment
participantsRefractory/Relapsed LDCBG
Complete response46
Uncertain complete response15
Partial response27
Stable disease9
Progressive disease38
Not evaluated10
PrimaryPredictive Value of R-IPI at Diagnosis
Time frame:
At diagnosis
Reported as:
Number · participants
Predictive Value of R-IPI at Diagnosis
participantsRefractory/Relapsed LDCBG
Global response to 2nd line + very good prognos4
No global response to 2nd line + very good prognos1
Global response to 2nd line + good prognosis28
No global response to 2nd line + good prognosis19
Global response to 2nd line + poor prognosis56
No global response to 2nd line + poor prognosis37
Statistical analysis
  • Refractory/Relapsed LDCBG · Fisher Exact · p = 0.812
SecondaryRelationship 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

Time frame:
At diagnosis
Reported as:
Number · participants
Relationship Between Global Response Rate to 2nd (Second) Line of Treatment and Bcl-2 Expression at Diagnosis
participantsRefractory/Relapsed LDCBG
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 ND30
No global response to 2nd line + Bcl-2 ND24
Statistical analysis
  • Refractory/Relapsed LDCBG · Chi-squared · p = 0.612
SecondaryRelationship 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

Time frame:
At diagnosis
Reported as:
Number · participants
Relationship Between Global Response Rate to 2nd Line of Treatment and Bcl-6 Expression at Diagnosis
participantsRefractory/Relapsed LDCBG
Global response to 2nd line + Bcl-6 +34
Global response to 2nd line + Bcl-6 -14
Global response to 2nd line + Blc-6 ND40
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 ND23
Statistical analysis
  • Refractory/Relapsed LDCBG · Chi-squared · p = 0.402
SecondaryRelationship 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

Time frame:
At diagnosis
Reported as:
Number · participants
Relationship Between Global Response Rate to 2nd Line of Treatment and p53 Expression at Diagnosis
participantsRefractory/Relapsed LDCBG
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 ND67
Global response to 2nd line + p53 - ND46
Statistical analysis
  • Refractory/Relapsed LDCBG · Chi-squared · p = 0.557
SecondaryRelationship 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

Time frame:
At diagnosis
Reported as:
Number · participants
Relationship Between Global Response Rate to 2nd Line of Treatment and Multiple Myeloma Oncogene 1 (MUM1) Expression at Diagnosis
participantsRefractory/Relapsed LDCBG
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 ND65
No global response to 2nd line + MUM1 ND42
Statistical analysis
  • Refractory/Relapsed LDCBG · Chi-squared · p = 0.234
Post-hocRelationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse

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
Reported as:
Number · participants
Relationship Between Global Response Rate to 2nd Line of Treatment and Absolute Lymphocyte Count on Relapse
participantsRefractory/Relapsed LDCBG
Global response to 2nd line + lymphocyte <140
Global response to 2nd line + lymphocyte >=147
No global response to 2nd line + lymphocyte <135
No global response to 2nd line + lymphocyte >=120
Statistical analysis
  • Refractory/Relapsed LDCBG · Fisher Exact · p = 0.057
Post-hocRelationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse

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
Reported as:
Number · participants
Relationship Between Global Response Rate to 2nd Line of Treatment and Lymphocyte/Monocyte Rate on Relapse
participantsRefractory/Relapsed LDCBG
Global response to 2nd line + ratio <=2.646
Global response to 2nd line + ratio >2.640
No global response to 2nd line + ratio <=2.637
No global response to 2nd line + ratio >2.618
Statistical analysis
  • Refractory/Relapsed LDCBG · Fisher Exact · p = 0.117
Post-hocRelationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse

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
Reported as:
Mean · mg/100ml
Relationship Between Global Response Rate to 2nd Line of Treatment and Beta-2 Microglobulin at Relapse
mg/100mlRefractory/Relapsed LDCBG
Global response to 2nd line2.47 ± 1.51
No global response to 2nd line2.41 ± 1.51

Adverse events

Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Refractory/Relapsed LDCBG—18/146 (12.3%)44/146 (30.1%)
Most frequent serious events
Most frequent serious events
EventRefractory/Relapsed LDCBG
NeutropeniaBlood and lymphatic system disorders7/146
LeucopeniaBlood and lymphatic system disorders6/146
TrombocitopeniaBlood and lymphatic system disorders4/146
AnemiaBlood and lymphatic system disorders1/146
Most frequent other events
Most frequent other events
EventRefractory/Relapsed LDCBG
Gastrointestinal symptomsGastrointestinal disorders18/146
FatigueGeneral disorders17/146
AnorexiaMetabolism and nutrition disorders9/146

Baseline characteristics

12 patients were not included in the data analysis for not fulfilling selection criteria

Age, Continuous
Age, Continuous(years)Refractory/Relapsed LDCBG
Mean58.4 ± 14.1
Sex: Female, Male
Sex: Female, Male(Participants)Refractory/Relapsed LDCBG
Female68
Male78
Ann Arbor Staging
Ann Arbor Staging(participants)Refractory/Relapsed LDCBG
I6
II20
III37
IV83
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status)
ECOG Performance Status (Eastern Cooperative Oncology Group Performance Status)(participants)Refractory/Relapsed LDCBG
ECOG 048
ECOG 155
ECOG 225
ECOG 315
ECOG 43
08

Study locations

56 sites
  • Hospital de Elda
    Elda, Alicante, Spain
  • Hospital de Cabueñes
    Gijón, Asturias, Spain
  • H. U. Central de Asturias
    Oviedo, Asturias, Spain
  • H. U. Germans Trias i Pujol
    Badalona, Barcelona, Spain
  • Hospital General de Granollers
    Granollers, Barcelona, Spain
  • ICO-DYR
    Hospitalet de Llobregat, Barcelona, Spain
  • Althaia
    Manresa, Barcelona, Spain
  • Hospital de Mataró
    Mataró, Barcelona, Spain
  • Hospital Parc Taulí
    Sabadell, Barcelona, Spain
  • H. Sierrallana
    Torrelavega, Cantabria, Spain
  • Hospital General del SAS de Jerez
    Jerez de la Frontera, Cádiz, Spain
  • Hospital Galdakao
    San Sebastián, Guipuzcoa, Spain
  • H. Clínico U. Santiago de Compostela
    Santiago de Compostela, La Coruña, Spain
  • Hospital San Pedro
    Logroño, La Rioja, Spain
  • H.U. Fundación Alcorcón
    Alcorcón, Madrid, Spain
  • H.U.de Getafe
    Getafe, Madrid, Spain
  • H. Severo Ochoa
    Leganés, Madrid, Spain
  • Hospital Costa del Sol
    Marbella, Málaga, Spain
  • Clínica Universitaria de Navarra
    Pamplona, Navarra, Spain
  • Hospital de Navarra
    Pamplona, Navarra, Spain
  • H. Universitario de Canarias
    La Laguna, Tenerife, Spain
  • H. Nuestra Señora del Prado
    Talavera de la Reina, Toledo, Spain
  • H. Basurto
    Bilbao, Vizcaya, Spain
  • Hospital Clinic i Provincial
    Barcelona, Spain
  • Hospital del Mar
    Barcelona, Spain
  • Hospital Vall D'Hebrón
    Barcelona, Spain
  • Institut Catalá d'Oncologia de Girona
    Gerona, Spain
  • H.U. Virgen de las Nieves
    Granada, Spain
  • Complejo Hospitalario de Jaén
    Jaén, Spain
  • C.H.U. A Coruña
    La Coruña, Spain
  • Hospital de León
    León, Spain
  • Hospital Xeral
    Lugo, Spain
  • Hospital Universitario Arnau de Vilanova
    Lérida, Spain
  • H. Ramón y Cajal
    Madrid, Spain
  • H. U. La Princesa
    Madrid, Spain
  • H.G.U. Gregorio Marañón
    Madrid, Spain
  • H.U. La Paz
    Madrid, Spain
  • Hospital 12 de Octubre
    Madrid, Spain
  • MD Anderson
    Madrid, Spain
  • Hospital Son Llatzer
    Mallorca, Spain
  • H.U. Virgen de la Arrixaca
    Murcia, Spain
  • Hospital Morales Messeguer
    Murcia, Spain
  • H. Carlos Haya
    Málaga, Spain
  • Complexo Hospitalario de Ourense
    Orense, Spain
  • Hospital Universitario Son Dureta
    Palma de Mallorca, Spain
  • H. Universitario de Salamanca
    Salamanca, Spain
  • H. General de Segovia
    Segovia, Spain
  • H.U. Nuestra Señora de Valme
    Sevilla, Spain
  • H. Arnau de Vilanova
    Valencia, Spain
  • H. Clínico de Valencia
    Valencia, Spain
  • H. Dr. Peset
    Valencia, Spain
  • H. Río Hortega
    Valladolid, Spain
  • Hospital Clínico Universitario Valladolid
    Valladolid, Spain
  • H. Virgen de La Concha
    Zamora, Spain
  • H. Nuestra Señora de Sonsoles
    Ávila, Spain
  • H. Txagorritxu
    Vitoria, Álava, Spain
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01369784
Lead sponsor
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
Responsible party
Sponsor
First posted
Jun 9, 2011
Start date
Feb 2009
Primary completion
Mar 2011
Completion
Mar 2011
Results posted
Apr 18, 2016
Last update
Apr 18, 2016

Study contacts

Carlos Panizo, PhD
study chair · Grupo Español de Linfomas/Trasplante Autólogo de Médula Ósea

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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