Non-Hodgkin's LymphomaPhase 2NCT01133158

R-BMD in Refractory or Relapsed Lymphoma, GELTAMO Clinical Trial

A Phase 2 study testing Rituximab, Bendamustine, Mitoxantrone, Dexamethasone in people with Non-Hodgkin's Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 41 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

Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Non-Hodgkin's Lymphoma
What is being tested?: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 61 participants
Where: 41 sitesSpain
Study dates: Jul 2009to Jul 2016
Phase: Phase 2
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 and ≤ 75 years.
Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue. Be accepted diagnosis in bone marrow if no accessible lymph nodes and whether it has discarded the mantle LLC, and NHL.
Follicular lymphoma patients treated with the combination of rituximab and chemotherapy in first line, which have been refractory or relapsed after having achieved any responses to this first line of pretreatment (excluding radiotherapy).
ECOG ≤ 2.
Signed written informed consent.

Who cannot join

Clinical suspicion or documentation of histological transformation.
Have received prior chemotherapy scheme, first line without Rituximab.
Prior autologous or allogeneic.
CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).
Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA)
HCV infection. HIV infection or other conditions of serious immunosuppression.

Show all 14Show fewer

Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
Cardiac function in cardiac patient known or prior treatment with anthracyclines with EF <50%.
Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, LSN) or a creatinine clearance <50 ml / h, not related to lymphoma.
Impaired liver function (bilirubin, AST / ALT or GGT> 2 x ULN) were not related to lymphoma.
Women who are nursing or pregnant. Women of childbearing potential will be included prior pregnancy test serum / urine negative. Use effective contraception to be kept for 1 year after cessation of rituximab.
Patients with heart disease, pulmonary, neurological, psychiatric or severe metabolic and not secondary to lymphoma.
Severe acute or chronic infection in activity.
Any other concurrent medical or psychological comorbidity that might interfere with participation in this study.

Trial locations and contacts

41 sites in 1 country.

City, postcode or hospital

41 sites in 1 country

Spain41 sites

Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Fundación de Alcorcón
Alcorcón, Madrid, 289222
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital Vall d´Hebron
Barcelona, 08035
Hospital Clinic i Provincial
Barcelona, 08036
Hospital de Basurto
Bilbao, 48013
Hospital San Pedro Alcántara
Cáceres, 10002
Hospital Puerta del Mar
Cadiz, 11009
Hospital Universitario Virgen de Arrixaca
El Palmar, Murcia, 30120
Hospital de Galdakao
Galdakao, Bilbao, 48960
Hospital de Getafe
Getafe, Madrid, 28901
Hospital de Jaén
Jaén, 23007
Hospital de Jerez
Jerez de la Frontera, Cádiz, 11407
Hospital Severo Ochoa
Leganés, Madrid, 28911
Hospital Gregorio Marañón
Madrid, 28009
Hospital Ramón y Cajal
Madrid, 28034
Hospital 12 de Octubre
Madrid, 28041
Hospital La Paz
Madrid, 28046
Hospital Puerta de Hierro
Majadahonda, Madrid, 28222
Complejo Hospitalario Carlos Haya
Málaga, 29010
Hospital Morales Meseguer
Murcia, 30008
Hospital Son Llàtzer
Palma de Mallorca, Mallorca, 07010
Hospital Son Espases
Palma de Mallorca, Mallorca, 07014
Clínica Universitaria de Navarra
Pamplona, Navarre, 31008
Hospital de Salamanca
Salamanca, 37007
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital San Juan de Alicante
Sant Joan d'Alacant, Alicante, 03550
Hospital Marqués de Valdecilla
Santander, Cantabria, 39008
Complejo Hospitalario Universitario de Santiago
Santiago, A Coruña, 15706
Hospital General de Segovia
Segovia, 42002
Hospital Virgen del Rocío
Seville, 41013
Hospital Clínico Universitario de Valencia
Valencia, 46010
Hospital General de Valencia
Valencia, 46014
Hospital Arnau de Vilanova
Valencia, 46015
Hospital Universitario Dr. Peset
Valencia, 46017
Hospital Río Hortega
Valladolid, 47012
Hospital Txagorritxu
Vitoria-Gasteiz, Alava, 01009
Hospital Virgen de la Concha
Zamora, 49022
Hospital Clínico de Zaragoza
Zaragoza, 50009
Hospital Miguel Servet
Zaragoza, 50009

Other trials in Spain

About this study

Official title: Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed

Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.

Read the detailed description

Assess the combination of efficacy and safety of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma who are refractory or in relapse.

Conditions: Non-Hodgkin's Lymphoma
Being tested: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone
Keywords: Follicular non-Hodgkin's lymphoma relapse refractory
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.

Rituximab, Bendamustine, Mitoxantrone, DexamethasoneDrug
Also called R-BMD
Bendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv

Study groups in NCT01133158
Study group	Role	What they receive
R-BMD	Experimental	Rituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years Receives: Drug: Rituximab, Bendamustine, Mitoxantrone, Dexamethasone

What is being measured

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

Response Rate
The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
Complete Remission (CR):
Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved
Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD
Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD
Progressive Disease (PD):
SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion
Measured: 7 years

Secondary outcomes (1)

Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
Measured: 7 years

Timeline

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

Jul 2009Jul 2016

First posted28 May 2010 (estimated)
Study startJul 2009
Primary completionDec 2013
Study completionJul 2016

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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Non-Hodgkin's 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: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 61 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01133158
Sponsor's protocol ID: R-BMD GELTAMO 08
Status last verified: Feb 2018
First submitted: 11 Feb 2010
Last updated: 1 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

Publications

Penalver FJ, Marquez JA, Duran S, Giraldo P, Martin A, Montalban C, Sancho JM, Ramirez MJ, Terol MJ, Capote FJ, Gutierrez A, Sanchez B, Lopez A, Salar A, Rodriguez-Caravaca G, Canales M, Caballero MD; GELTAMO (The Spanish Lymphoma Cooperative Group). Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial. Cancer Med. 2019 Nov;8(16):6955-6966. doi: 10.1002/cam4.2555. Epub 2019 Oct 1.
PubMed 31573746

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 1 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine, Mitoxantrone, Dexamethasone (R-BMD) in Patients With Follicular Lymphoma Refractory or Relapsed
ClinicalTrials.gov ID: NCT01133158
Acronym / sponsor ID: R-BMD GELTAMO 08
Conditions: Non-Hodgkin's Lymphoma
Keywords: Follicular non-Hodgkin's lymphoma relapse refractory
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 61 participants (actual)
Lead sponsor: Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
Study start: Jul 2009
Primary completion: Dec 2013 (actual)
Study completion: Jul 2016 (actual)
First posted: 28 May 2010 (estimated)
Results: Posted 1 Nov 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Assess the combination of efficacy of the combination of rituximab, bendamustine, mitoxantrone, dexamethasone in the treatment of patients with Follicular Lymphoma.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
R-BMD	Experimental	Drug: Rituximab, Bendamustine, Mitoxantrone, DexamethasoneRituximab, Bendamustine, Mitoxantrone, Dexamethasone Induction: 6 Rituximab, Bendamustine, Mitoxantrone, Dexamethasone cycles Maintenance: Rituximab every 3 months for 2 years

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Age ≥ 18 and ≤ 75 years.
Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue. Be accepted diagnosis in bone marrow if no accessible lymph nodes and whether it has discarded the mantle LLC, and NHL.
Follicular lymphoma patients treated with the combination of rituximab and chemotherapy in first line, which have been refractory or relapsed after having achieved any responses to this first line of pretreatment (excluding radiotherapy).
ECOG ≤ 2.
Signed written informed consent.

Key exclusion criteria (14 listed)

Clinical suspicion or documentation of histological transformation.
Have received prior chemotherapy scheme, first line without Rituximab.
Prior autologous or allogeneic.
CNS infiltration by LF (primary CNS lymphoma or lymphomatous meningitis).
Past or active Hepatitis B (at least one of the following markers HBsAg, HBe Ag, anti-HBc, HBV DNA)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Rituximab, Bendamustine, Mitoxantrone, DexamethasoneAlso: R-BMDBendamustine: 90 mg/m2/day, days 1 and 2 of each cycle, iv Mitoxantrone: 6 mg/m2/day, day 1 of each cycle, iv Dexamethasone 20 mg / day, days 1 through 5 of each cycle, od Rituximab: 375 mg / m 2 / day, day 1 of each cycle, iv	Drug	R-BMD

Primary outcome

Response Rate
Time frame: 7 years
The primary endpoint is the number of Participants with Response according to the criteria of the International Workshop to Standardize Response Criteria for NHL Complete Remission (CR): Nodes returned to normal (if GTD >15 mm before therapy, GTD now ≤15 mm; if GTD 11-15 and SA >10 mm before therapy, SA now ≤10 mm) All (non-nodal) target lesions completely resolved Partial Remission (PR) SPD of target lesions decreased ≥50% from baseline Spleen and liver nodules regress by 50% in SPD or single lesion in GTD Stable Disease (SD) Not enough shrinkage for PR Not enough growth for PD Progressive Disease (PD): SPD increase ≥50% from nadir (smallest value seen during trial) in nodal target lesions overall or in any single nodal target lesion

1 secondary outcome

Secondary Endpoints Included an Assessment of the Following Parameters: Progression-Free Survival, Disease-Free Survival, Global Survival, Duration of the Response.
Time frame: 7 years

Results and safety

Results posted to the registry on 1 Nov 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone	60	43

Primary outcome: Response Rate

Time frame: 7 years. Count of participants. Unit: Participants

Measure	Induction Rituximab, Bendamustine, Mitoxantrone, Dexamethasone n = 60	Maintenance Rituximab n = 43
Value	57	35

Population analysed: Number of Participants analyzed in the Maintenance Rituximab Arm reflects all participants who received at least one dose of Rituximab during maintenance, and had available data for response during that phase

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 9 years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Rituximab, Bendamustine, Mitoxantrone, Dexamethasone	22 of 60 (36.7%)	60 of 60 (100%)	1 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31573746Penalver FJ, Marquez JA, Duran S, Giraldo P, Martin A, Montalban C, Sancho JM, Ramirez MJ, Terol MJ, Capote FJ, Gutierrez A, Sanchez B, Lopez A, Salar A, Rodriguez-Caravaca G, Canales M, Caballero MD; GELTAMO (The Spanish Lymphoma Cooperative Group). Response-adapted treatment with rituximab, bendamustine, mitoxantrone, and dexamethasone followed by rituximab maintenance in patients with relapsed or refractory follicular lymphoma after first-line immunochemotherapy: Results of the RBMDGELTAMO08 phase II trial. Cancer Med. 2019 Nov;8(16):6955-6966. doi: 10.1002/cam4.2555. Epub 2019 Oct 1.
Individual participant dataSharing planned: Undecided

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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.

Francisco Javier Peñalver Párraga, MD principal investigator

Hospital Universitario Fundación Alcorcón

Javier De la Serna Torroba, MD principal investigator

Hospital 12 de Octubre

Francisca Oña Compan, MD principal investigator

Hospital de Getafe.

41 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 5 inclusion and 14 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 1 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 1 Nov 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?

Response Rate (time frame: 7 years). 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 NCT01133158, which also lists 1 linked publication.

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 1 Nov 2018.