AzTrials
AzTrials

Lymphoma, Non HodgkinPhase 3NCT01987505

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

A Phase 3 study testing Rituximab in people with Lymphoma, Non Hodgkin, run by Hoffmann-La Roche at 39 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Lymphoma, Non Hodgkin
What is being tested?
Rituximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
39 sitesSpain
Study dates
11 Nov 2013to 11 Apr 2017
Phase
Phase 3
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 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 10Show fewer
  • 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.

Who cannot join

  • 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.
Show all 13Show fewer
  • 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.

Trial locations and contacts

39 sites in 1 country.

39 sites in 1 country

Spain39 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Hematologia

    A Coruña, LA Coruña, 15006

  • Complejo Hospitalario Torrecardenas; Servicio de Hematologia

    Almería, 04009

  • Hospital de Basurto; Servicio de Hematologia

    Bilbao, Vizcaya, 48013

  • Hospital Universitario de Burgos, Servicio de Hematología

    Burgos, 09006

  • Hospital General de Castellon; Servicio de Hematologia

    Castellon, Castellon, 12004

  • Hospital Universitario Reina Sofia; Servicio de Hematologia

    Córdoba, 14004

  • Hospital General de Elda; Servicio de Hematologia

    Elda, Alicante, 03600

  • Hospital Universitario de Fuenlabrada; Servicio de Hematologia

    Fuenlabrada, Madrid, 28943

  • Hospital de Galdakano; Servicio de Hematologia

    Galdakao, Vizcaya, 48960

  • Hospital Universitario Virgen de las Nieves; Servicio de Hematologia

    Granada, 18014

  • Hospital de Granollers, Servicio de Hematología

    Granollers, Barcelona, 08400

  • Hospital Universitario de Gaudalajara; Hematología

    Guadalajara, 19002

  • Hospital Severo Ochoa; Servicio de Hematologia

    Leganés, Madrid, 28911

  • Complejo Asistencial de León, Servicio de Hematología

    León, LEON, 24008

  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Hematologia

    Lleida, 25198

  • Complejo Hospitalario San Millan - San Pedro; Servicio Hematologia

    Logroño, La Rioja, 26006

  • Hospital Infanta Leonor; Servicio de Hematologia

    Madrid, 28031

  • Fundacion Jimenez Diaz; Servicio de Hematologia

    Madrid, 28040

  • Hospital Universitario Clínico San Carlos; Servicio de Hematología

    Madrid, 28040

  • HOSPITAL DE MADRID NORTE SANCHINARRO- CENTRO INTEGRAL ONCOLOGICO CLARA CAMPAL; Servicio Hematologia

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro; Servicio de Hematologia

    Madrid, 28222

  • Hospital Universitario Principe de Asturias; Servicio de Hematología

    Madrid, 28805

  • Hospital Univ. Virgen de la Victoria

    Málaga, 29010

  • Hosital Universitario de Mostoles;Servicio de Hematologia

    Móstoles, Madrid, 28935

  • Hospital General Universitario J.M Morales Meseguer; Servicio de Hematología

    Murcia, 30008

  • Hospital Universitario Virgen de Arrixaca; Servicio de Hematologia

    Murcia, 30120

  • Hospital Son Llatzer; Servicio de Hematologia

    Palma de Mallorca, Balearic Islands, 07198

  • Clinica Universitaria de Navarra; Servicio de Hematologia

    Pamplona, Navarre, 31008

  • Hospital de Navarra, Servicio de Hematología

    Pamplona, Navarre, 31008

  • Complejo Hospitalario de Pontevedra; Servicio de Hematologia

    Pontevedra, 36071

  • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Oncologia

    Santa Cruz de Tenerife, Tenerife, 38010

  • Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Hematologia

    Santiago de Compostela, LA Coruña, 15706

  • Complejo Asistencial de Segovia

    Segovia, 40002

  • Hospital Universitario Virgen Macarena; Servicio de Hematologia

    Seville, 41009

  • Hospital Univ. Nuestra Señora de Valme; Servicio de Hematologia

    Seville, 41014

  • Hospital Mutua de Terrassa; Servicio de Hematologia

    Terrassa, Barcelona, 08221

  • Hospital de Rio Hortega; Servicio de Hematologia

    Valladolid, 47010

  • Complejo Hospitalario Universitario de Vigo; Servicio de Hematologia

    Vigo, Pontevedra, 36204

  • Hospital De Txagorritxu; Servicio de Hematologia

    Vitoria-Gasteiz, Alava, 01009

Other trials in Spain

About this study

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.

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.

Being tested
Rituximab
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called MabThera, Rituxan

    1400 mg will be injected subcutaneously (SC).

Study groups in NCT01987505
Study groupRoleWhat they receive
Subcutaneous RituximabExperimentalParticipants 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.
Receives: Drug: Rituximab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From start of treatment to end of treatment (up to 32 months)

Secondary outcomes (8)

  1. 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.

    Measured: From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)

  2. 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.

    Measured: From start of treatment to end of treatment (up to 32 months)

  3. 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.

    Measured: From start of recruitment (10 months period) up to end of treatment at 32 months (total period up to 42 months)

  4. 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.

    Measured: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

  5. 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.

    Measured: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

  6. Overall Survival (OS)

    OS was defined as the time from first dose of rituximab IV to death from any cause.

    Measured: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

  7. 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.

    Measured: From time of first dose of rituximab IV before study enrollment up to end of study (up to approximately 62 months)

  8. 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.

    Measured: 4-6 weeks after the last dose of Induction (Up to approximately 8 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2013 (estimated)
  2. Study start11 Nov 2013
  3. Primary completion11 Apr 2017
  4. Study completion11 Apr 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01987505
Sponsor's protocol ID
ML28943
Other IDs
2013-001118-14
Status last verified
Dec 2018
First submitted
8 Nov 2013
Last updated
26 Dec 2018
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 35126524

  • 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.

    PubMed 31573078

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab in people with Lymphoma, Non Hodgkin, run by Hoffmann-La Roche at 39 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?

The sponsor lists 10 inclusion and 13 exclusion criteria. 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 26 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 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.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Jul 2018). 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?

Percentage of Participants With Administration-Associated Reactions (AARs) (time frame: From start of treatment to end of treatment (up to 32 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01987505, which also lists 2 linked publications.

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 26 Dec 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in