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MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma

Primary Purpose

Lymphoma, Non Hodgkin

Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Rituximab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphoma, Non Hodgkin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age ≥ 18 and ≤ 80 years at time of enrolment.
  • Life expectancy ≥ 6 months.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3.
  • Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant.
  • Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system.

Induction only:

  • Participants with Follicular Lymphoma should meet Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria to initiate treatment.
  • At least tumor >/= 1.5 cm as measured by computed tomography (CT) scan.

FL treatment-related criteria

- Currently being treated with rituximab IV during first-line therapy and has received at least one full dose of rituximab IV.

Exclusion Criteria:

  • Transformed lymphoma.
  • Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma.
  • History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for >/= 5 years prior to dosing. Note: Participants with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study.
  • Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Note: Participants receiving corticosteroid treatment with </= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing.
  • Inadequate renal, hematologic, or hepatic function.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products.
  • For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment.
  • For participants with FL: contraindication to standard chemotherapy.
  • Other serious underlying medical conditions.
  • Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis.
  • Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing.
  • Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note: Participants testing positive for Hepatitis B or C virus antibodies but with an undetectable viral load may be included.
  • History of Human Immunodeficiency Virus (HIV) positive status.

Sites / Locations

  • Hospital De Txagorritxu; Servicio de Hematologia
  • Hospital General de Elda; Servicio de Hematologia
  • Hospital de Granollers, Servicio de Hematología
  • Hospital Mutua de Terrassa; Servicio de Hematologia
  • Hospital Son Llatzer; Servicio de Hematologia
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia
  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Hematologia
  • Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia
  • Complejo Asistencial de León, Servicio de Hematología
  • Hospital Universitario de Fuenlabrada; Servicio de Hematologia
  • Hospital Severo Ochoa; Servicio de Hematologia
  • Hosital Universitario de Mostoles;Servicio de Hematologia
  • Clinica Universitaria de Navarra; Servicio de Hematologia
  • Hospital de Navarra, Servicio de Hematología
  • Complejo Hospitalario Universitario de Vigo; Servicio de Hematologia
  • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
  • Hospital de Basurto; Servicio de Hematologia
  • Hospital de Galdakano; Servicio de Hematologia
  • Complejo Hospitalario Torrecardenas; Servicio de Hematologia
  • Hospital Universitario de Burgos, Servicio de Hematología
  • Hospital General de Castellon; Servicio de Hematologia
  • Hospital Universitario Reina Sofia; Servicio de Hematologia
  • Hospital Universitario Virgen de las Nieves; Servicio de Hematologia
  • Hospital Universitario de Gaudalajara; Hematología
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Hematologia
  • Hospital Infanta Leonor; Servicio de Hematologia
  • Fundacion Jimenez Diaz; Servicio de Hematologia
  • Hospital Universitario Clínico San Carlos; Servicio de Hematología
  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
  • Hospital Universitario Puerta de Hierro; Servicio de Hematologia
  • Hospital Universitario Principe de Asturias; Servicio de Hematología
  • Hospital Univ. Virgen de la Victoria
  • Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología
  • Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia
  • Complejo Hospitalario de Pontevedra; Servicio de Hematologia
  • Complejo Asistencial de Segovia
  • Hospital Universitario Virgen Macarena; Servicio de Hematologia
  • Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia
  • Hospital de Rio Hortega; Servicio de Hematologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Subcutaneous Rituximab

Arm Description

Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab will be treated with subcutaneous (SC) rituximab. Participants with FL will be administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL will be administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.

Outcomes

Primary Outcome Measures

Percentage of Participants With Administration-Associated Reactions (AARs)
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.

Secondary Outcome Measures

Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0.
Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)
Grading of IIRRs was completed according to the CTCAE, version 4.0.
Percentage of Participants With At Least One Serious Adverse Event (SAE)
SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Event-Free Survival (EFS)
EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Progression-Free Survival (PFS)
PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Overall Survival (OS)
OS was defined as the time from first dose of rituximab IV to death from any cause.
Disease-Free Survival (DFS)
DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.
Treatment Response Rate
Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: >/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.

Full Information

First Posted
November 8, 2013
Last Updated
December 4, 2018
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT01987505
Brief Title
MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma
Official Title
Open Label, Single-arm, Phase IIIb Clinical Trial to Evaluate the Safety of Switching From Intravenous Rituximab to Subcutaneous Rituximab During First Line Treatment for CD20+ Non-Hodgkin's Follicular Lymphoma and Diffuse Large B-cell Lymphoma.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
November 11, 2013 (Actual)
Primary Completion Date
April 11, 2017 (Actual)
Study Completion Date
April 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

Brief Summary
This open-label, single-arm, phase IIIb study will evaluate the safety of switching from intravenous (IV) to subcutaneous (SC) administration of rituximab during first-line treatment for participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL) who have already received at least one full dose of rituximab IV. Participants with FL will be given 1400 mg rituximab SC during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). 1400 mg SC of rituximab will be given to participants with DLBCL once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphoma, Non Hodgkin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Subcutaneous Rituximab
Arm Type
Experimental
Arm Description
Participants with CD20+ non-Hodgkin's follicular lymphoma (FL) or diffuse large B-cell lymphoma (DLBCL), who had already received at least one full dose of intravenous (IV) rituximab will be treated with subcutaneous (SC) rituximab. Participants with FL will be administered 1400 mg rituximab during induction therapy (once monthly for 4-7 cycles) and maintenance therapy (once every 2 months for 6-12 cycles). Participants with DLBCL will be administered 1400 mg SC of rituximab once monthly for 4-7 cycles. Treatment duration is expected to last up to 7 months for participants with DLBCL and up to 32 months for participants with FL.
Intervention Type
Drug
Intervention Name(s)
Rituximab
Other Intervention Name(s)
MabThera, Rituxan
Intervention Description
1400 mg will be injected subcutaneously (SC).
Primary Outcome Measure Information:
Title
Percentage of Participants With Administration-Associated Reactions (AARs)
Description
AARs were defined as all adverse events (AEs) occurring within 24 hours of rituximab SC administration and which were considered related to study drug. AARs included infusion/injection-related reactions (IIRRs), injection-site reactions, administration site conditions and all symptoms thereof. Grading was completed according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.0.
Time Frame
From start of treatment to end of treatment (up to 32 months)
Secondary Outcome Measure Information:
Title
Percentage of Participants With At Least One Grade >/= 3 Adverse Events (AEs)
Description
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Pre-existing conditions which worsen during a study are also considered as adverse events. Grading was completed according to the CTCAE, version 4.0.
Time Frame
From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
Title
Percentage of Participants With At Least One Grade >/= 3 Infusion/ Injection Related Reactions (IIRRs)
Description
Grading of IIRRs was completed according to the CTCAE, version 4.0.
Time Frame
From start of treatment to end of treatment (up to 32 months)
Title
Percentage of Participants With At Least One Serious Adverse Event (SAE)
Description
SAE was defined as any experience that suggested a significant hazard, contraindication, side effect, or precaution, and fulfilled any of the following criteria: fatal (resulted in death), life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/ birth defect, was medically significant or required intervention to prevent any of the other outcomes listed here.
Time Frame
From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)
Title
Event-Free Survival (EFS)
Description
EFS was defined as the time from first dose of rituximab IV to first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or initiation of a non-protocol-specified anti-lymphoma therapy or death, whichever occurs first. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Time Frame
From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)
Title
Progression-Free Survival (PFS)
Description
PFS was defined as the time from first dose of rituximab IV to the first occurrence of progressive disease (PD) or relapse, according to the International Working Group (IWG) response criteria or death from any cause. PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Time Frame
From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)
Title
Overall Survival (OS)
Description
OS was defined as the time from first dose of rituximab IV to death from any cause.
Time Frame
From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)
Title
Disease-Free Survival (DFS)
Description
DFS was assessed in participants achieving complete response (CR) including complete response unconfirmed (Cru) and was defined as the period from the date of the initial CR/CRu until the date of relapse or death from any cause. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow. Reported here is the truncated mean estimate based on Kaplan-Meier analysis.
Time Frame
From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)
Title
Treatment Response Rate
Description
Treatment response rate was classified according to the International Working Group (IWG) response criteria: CR/Cru, partial response (PR), stable disease (SD) and PD. CR: 1) disappearance of all evidence/symptoms of disease, 2) lymph nodes and nodal masses normal size, 3) enlarged spleen must have regressed in size, 4) normal bone marrow; CRu: see 1) and 3) of CR plus > 75% decrease in residual lymph node mass, indeterminate bone marrow; PR: >/= 50% decrease lymph nodes and nodal mass size; decrease in liver/spleen size, no new sites; SD: less than a PR, but is not PD; PD: >/= 50% increase lymph nodes and nodal mass size, any new lesion, enlarged liver/spleen, reappearance bone marrow abnormalities.
Time Frame
4-6 weeks after the last dose of Induction (Up to approximately 8 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 and ≤ 80 years at time of enrolment. Life expectancy ≥ 6 months. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 3. Fertile men or women of childbearing potential must use effective contraception until at least 12 months after the last dose; women must not be pregnant. Histologically confirmed CD20+ diffuse large B-cell lymphoma (DLBCL) or CD20+ follicular Non-Hodgkin Lymphoma (FL) grade 1, 2 or 3a according to the World Health Organisation Classification system. Induction only: Participants with Follicular Lymphoma should meet Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria to initiate treatment. At least tumor >/= 1.5 cm as measured by computed tomography (CT) scan. FL treatment-related criteria - Currently being treated with rituximab IV during first-line therapy and has received at least one full dose of rituximab IV. Exclusion Criteria: Transformed lymphoma. Primary central nervous system lymphoma, primary effusion lymphoma, primary mediastinal DLBCL, DLBCL of the testis, primary cutaneous DLBCL or histologic evidence of transformation to a Burkitt lymphoma. History of other cancer, including one that has been treated but not with curative intent, unless the cancer has been in remission without treatment for >/= 5 years prior to dosing. Note: Participants with a history of cured skin cancer or in situ carcinoma of the cervix are eligible for the study. Ongoing corticosteroid use > 30 mg/day of prednisone or equivalent. Note: Participants receiving corticosteroid treatment with </= 30 mg/day of prednisone or equivalent must be on a stable regimen for at least 4 weeks prior to start of dosing. Inadequate renal, hematologic, or hepatic function. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products. For participants with DLBCL: Contraindication to any of the individual components of CHOP (cyclophosphamide, vincristine, doxorubicin and prednisone), including prior anthracycline treatment. For participants with FL: contraindication to standard chemotherapy. Other serious underlying medical conditions. Recent major surgery (within 4 weeks prior to dosing), other than for diagnosis. Active and/or severe infections (excluding nail fungal infections) or any infection requiring treatment with IV antibiotics or hospitalization within 4 weeks prior to dosing. Active Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection. Note: Participants testing positive for Hepatitis B or C virus antibodies but with an undetectable viral load may be included. History of Human Immunodeficiency Virus (HIV) positive status.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Hospital De Txagorritxu; Servicio de Hematologia
City
Vitoria
State/Province
Alava
ZIP/Postal Code
01009
Country
Spain
Facility Name
Hospital General de Elda; Servicio de Hematologia
City
Elda
State/Province
Alicante
ZIP/Postal Code
03600
Country
Spain
Facility Name
Hospital de Granollers, Servicio de Hematología
City
Granollers
State/Province
Barcelona
ZIP/Postal Code
08400
Country
Spain
Facility Name
Hospital Mutua de Terrassa; Servicio de Hematologia
City
Terrassa
State/Province
Barcelona
ZIP/Postal Code
08221
Country
Spain
Facility Name
Hospital Son Llatzer; Servicio de Hematologia
City
Palma de Mallorca
State/Province
Islas Baleares
ZIP/Postal Code
07198
Country
Spain
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia
City
La Coruna
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Hematologia
City
Santiago de Compostela
State/Province
LA Coruña
ZIP/Postal Code
15706
Country
Spain
Facility Name
Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia
City
Logroño
State/Province
LA Rioja
ZIP/Postal Code
26006
Country
Spain
Facility Name
Complejo Asistencial de León, Servicio de Hematología
City
León
State/Province
Leon
ZIP/Postal Code
24008
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada; Servicio de Hematologia
City
Fuenlabrada
State/Province
Madrid
ZIP/Postal Code
28943
Country
Spain
Facility Name
Hospital Severo Ochoa; Servicio de Hematologia
City
Leganes
State/Province
Madrid
ZIP/Postal Code
28911
Country
Spain
Facility Name
Hosital Universitario de Mostoles;Servicio de Hematologia
City
Mostoles
State/Province
Madrid
ZIP/Postal Code
28935
Country
Spain
Facility Name
Clinica Universitaria de Navarra; Servicio de Hematologia
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Hospital de Navarra, Servicio de Hematología
City
Pamplona
State/Province
Navarra
ZIP/Postal Code
31008
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Vigo; Servicio de Hematologia
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36204
Country
Spain
Facility Name
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia
City
Santa Cruz de Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Hospital de Basurto; Servicio de Hematologia
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital de Galdakano; Servicio de Hematologia
City
Galdakao
State/Province
Vizcaya
ZIP/Postal Code
48960
Country
Spain
Facility Name
Complejo Hospitalario Torrecardenas; Servicio de Hematologia
City
Almeria
ZIP/Postal Code
04009
Country
Spain
Facility Name
Hospital Universitario de Burgos, Servicio de Hematología
City
Burgos
ZIP/Postal Code
09006
Country
Spain
Facility Name
Hospital General de Castellon; Servicio de Hematologia
City
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital Universitario Reina Sofia; Servicio de Hematologia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Facility Name
Hospital Universitario Virgen de las Nieves; Servicio de Hematologia
City
Granada
ZIP/Postal Code
18014
Country
Spain
Facility Name
Hospital Universitario de Gaudalajara; Hematología
City
Guadalajara
ZIP/Postal Code
19002
Country
Spain
Facility Name
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Hematologia
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
Hospital Infanta Leonor; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Fundacion Jimenez Diaz; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Hematología
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia
City
Madrid
ZIP/Postal Code
28050
Country
Spain
Facility Name
Hospital Universitario Puerta de Hierro; Servicio de Hematologia
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital Universitario Principe de Asturias; Servicio de Hematología
City
Madrid
ZIP/Postal Code
28805
Country
Spain
Facility Name
Hospital Univ. Virgen de la Victoria
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Complejo Hospitalario de Pontevedra; Servicio de Hematologia
City
Pontevedra
ZIP/Postal Code
36071
Country
Spain
Facility Name
Complejo Asistencial de Segovia
City
Segovia
ZIP/Postal Code
40002
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Hematologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital de Rio Hortega; Servicio de Hematologia
City
Valladolid
ZIP/Postal Code
47010
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
35126524
Citation
Petrini M, Gaidano G, Mengarelli A, Consoli U, Santoro A, Liberati AM, Ladetto M, Fraticelli V, Guarini A, Mannina D, Ferrando P, Corradini P, Musto P, Stelitano C, Marino D, Camera A, Murineddu M, Battistini R, Caparrotti G, Turrini M, Arcaini L, Santini S, Cerqueti M, Ferreri AJM, Cantore N, Inzoli A, Cardinale G, Ronci B, La Nasa G, Massimi S, Gaglione G, Barbiero V, Martelli M. Safety and Efficacy of Subcutaneous Rituximab in Previously Untreated Patients with CD20+ Diffuse Large B-Cell Lymphoma or Follicular Lymphoma: Results from an Italian Phase IIIb Study. Adv Hematol. 2022 Jan 27;2022:5581772. doi: 10.1155/2022/5581772. eCollection 2022.
Results Reference
derived
PubMed Identifier
31573078
Citation
Garcia-Munoz R, Quero C, Perez-Persona E, Domingo-Garcia A, Perez-Lopez C, Villaescusa-de-la-Rosa T, Martinez-Castro AM, Arguinano-Perez JM, Parra-Cuadrado JF, Panizo C. Safety of switching from intravenous to subcutaneous rituximab during first-line treatment of patients with non-Hodgkin lymphoma: the Spanish population of the MabRella study. Br J Haematol. 2020 Mar;188(5):661-673. doi: 10.1111/bjh.16227. Epub 2019 Oct 1.
Results Reference
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MabRella Study: A Study to Evaluate the Safety of Switching From Intravenous to Subcutaneous Administration of Rituximab During First-Line Treatment for Lymphoma

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