Aggressive LymphomaPhase 2RGemOxNCT01562977
Study to Evaluate Efficacy and Tolerance of R-GemOx in DLBCL and MCL
A Phase 2 study testing Rituximab, Gemcitabine, Oxaliplatin, Dexametasone in people with Aggressive Lymphoma and Diffuse Large B-cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 28 sites in Spain.
Trial summary
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aggressive Lymphoma, Diffuse Large B-cell Lymphoma, Mantle Cell Lymphoma
- What is being tested?
- Rituximab, Gemcitabine, Oxaliplatin, Dexametasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 28 sitesSpain
- Study dates
- Apr 2011to Apr 2015
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- DLBCL and MCL diagnosed patients in primary resistance or relapsed not eligible for intensification chemotherapy followed by Autologous stem cell transplantation (ASCT) for age, comorbidity or previous ASCT.
- Any IPI or ECOG, capable of understanding the nature of the trial.
- Writtern Informed Consent.
Who cannot join
- Nursing pregnant or lactation period women, or fertile age adults not using effective contraceptive method.
- CNS lymphoma patients.
- Patients with severa renal (creatinine> 2,5 UNL) or hepatic (Bilirrubin or ALT/AST> 2,5 UNL) impairement not provided by the same disease
- HIV positive patients.
- Serious psychiatric diseases patients that could interfere with their skill to understand the study (including alcoholism or drug addiction).
- Murine proteins or any other component of the medicines of the study hypersensitivity patients.
- Patients who have received more than 2 therapeutic previous lines. (for previous ASCT patients, induction and conditioning for the TAPH treatment is considered a single line therapy).
Trial locations and contacts
28 sites in 1 country.
28 sites in 1 country
Spain28 sites
Complejo Hospitalario de A Coruña
A Coruña
Fundación Hospital de Alcorcón
Alcorcón, Madrid
Hospital Dr. Jose Molina Orosa
Arrecife, Lanzarote
Hospital Germans Trias i Pujol
Badalona, Barcelona
Hospital Santa Creu i Sant Pau
Barcelona
Hospital Vall d´Hebrón
Barcelona
Hospital Virgen de Arrixaca
El Palmar, Murcia
Hospital SAS de Jerez
Jerez de la Frontera, Cádiz
Hospital 12 Octubre
Madrid
Hospital Gregorio Marañón
Madrid
Hospital La Paz
Madrid
Hospital Ramón y Cajal
Madrid
Hospital Puerta de Hierro de Majadahonda
Majadahonda, Madrid
Hospital Morales Meseguer
Murcia
Hospital Son Espasses
Palma de Mallorca
Hospital Son Llàtzer
Palma de Mallorca
Clinica Universitaria de Navarra
Pamplona
Hospital Duran i Reynals
Sabadell, Barcelona
Corporació Sanitari Parc Taulí
Sabadell
Hospital Clínico de Salamanca
Salamanca
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital Marqués de Valdecilla
Santander
Complejo Hospitalario Universitario de Santiago
Santiago de Compostela
Hospital Dr. Peset
Valencia
Hospital La Fe
Valencia
Hospital Virgen de la Concha
Zamora
Hospital Clínico Lozano Blesa
Zaragoza
Hospital Miguel Servet
Zaragoza
About this study
Official title: Prospective, Open-label, Multicentric, ph. II Study of R-GemOx and Dexametasone in Patients With Agressive Lymphomas Refractory or Relapsed to Previous Treatment and Non Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplanted
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
Read the detailed description
The purpose of this study is to determine efficacy (overall response rate (ORR) and complete response) tolerance and toxicity of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
- Being tested
- Rituximab, Gemcitabine, Oxaliplatin, Dexametasone
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab, Gemcitabine, Oxaliplatin, DexametasoneDrug
until progression or unacceptable toxicity develops, 8 cicles max Rituximab: 375 mg/m2, IV, day 1. Gemcitabine: 1000 mg/m2, IV, day 2. Oxaliplatin: 100 mg/m2, IV, day 2. Dexametasone: 20 mg/day, days 1-3, oral.
| Study group | Role | What they receive |
|---|---|---|
| no arms | Other | no arms were present for the study, only 2 different cohorts:MCL and LDCGB Receives: Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is to evaluate Overall response rate (ORR)
The primary endpoint is to evaluate the number of patients with complete remission, unconfirmed complete remission and partial response according to International Workshop to Standardize Response Criteria for NHL, of R-GEMOX combination administered every 14 days
Measured: 3 years and 2 months
Secondary outcomes (2)
Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)
To asses the number of Participants with Adverse Events (serious and non serious) and classification of those adverse events.
Evaluate if the balance efficacy / toxicity allows the possibility of further interventions to prolong progression-free survival and overall survival
Measured: 3 years and 2 months
To identify clinical response predictive factors
To asses if different age, sex, IPI, ECOG, stage of cancer, dissease location and time to relapse have some influence in response.
Measured: 3 years 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study startApr 2011
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aggressive 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
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ana Mendez Lopez, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Investigators
- Andrés López Hernández, MD, Principal investigator, Hospital Vall d´HebrónMª Dolores Caballero Barrigón, MD, Principal investigator, Hospital Clínico de SalamancaJorge Gayoso Cruz, MD, Principal investigator, Hospital Universitario Gregorio MarañónJuan Alfonso Soler Campos, MD, Principal investigator, Corporació Sanitari Parc TaulíCarlos Montalbán Sanz, MD, Principal investigator, Hospital Universitario Ramon y CajalJuan Manuel Sancho Cía, MD, Principal investigator, Germans Trias i Pujol HospitalIsidro Jarque, MD, Principal investigator, Hospital Universitario La FeSecundino Ferrer, MD, Principal investigator, Hospital Dr. Peset
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01562977
- Sponsor's protocol ID
- GEL-TAMO/R-GemOx-08-04/v2
- Acronym
- RGemOx
- Status last verified
- Oct 2017
- First submitted
- 18 Jul 2011
- Last updated
- 30 Oct 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Open-label, Multicentric, ph. II Study of R-GemOx and Dexametasone in Patients With Agressive Lymphomas Refractory or Relapsed to Previous Treatment and Non Eligible for High-dose Chemotherapy Followed by Autologous Stem Cell Transplanted
- ClinicalTrials.gov ID
- NCT01562977
- Acronym / sponsor ID
- RGemOx / GEL-TAMO/R-GemOx-08-04/v2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 26 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine efficacy of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
Detailed description
The purpose of this study is to determine efficacy (overall response rate (ORR) and complete response) tolerance and toxicity of rituximab, gemcitabine, oxaliplatin and dexametasone (R-GemOx) chemotherapy schedule.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| no arms | Other | Drug: Rituximab, Gemcitabine, Oxaliplatin, Dexametasoneno arms were present for the study, only 2 different cohorts:MCL and LDCGB |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years.
- DLBCL and MCL diagnosed patients in primary resistance or relapsed not eligible for intensification chemotherapy followed by Autologous stem cell transplantation (ASCT) for age, comorbidity or previous ASCT.
- Any IPI or ECOG, capable of understanding the nature of the trial.
- Writtern Informed Consent.
Key exclusion criteria (7 listed)
- Nursing pregnant or lactation period women, or fertile age adults not using effective contraceptive method.
- CNS lymphoma patients.
- Patients with severa renal (creatinine> 2,5 UNL) or hepatic (Bilirrubin or ALT/AST> 2,5 UNL) impairement not provided by the same disease
- HIV positive patients.
- Serious psychiatric diseases patients that could interfere with their skill to understand the study (including alcoholism or drug addiction).
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, Gemcitabine, Oxaliplatin, Dexametasoneuntil progression or unacceptable toxicity develops, 8 cicles max Rituximab: 375 mg/m2, IV, day 1. Gemcitabine: 1000 mg/m2, IV, day 2. Oxaliplatin: 100 mg/m2, IV, day 2. Dexametasone: 20 mg/day, days 1-3, oral. | Drug | no arms |
Primary outcome
The primary endpoint is to evaluate Overall response rate (ORR)
Time frame: 3 years and 2 months
The primary endpoint is to evaluate the number of patients with complete remission, unconfirmed complete remission and partial response according to International Workshop to Standardize Response Criteria for NHL, of R-GEMOX combination administered every 14 days
2 secondary outcomes
Safety of Gemcitabine in combination with Rituximab, Oxaliplatin and Dexametasone (R-GemOx) in DLBCL and Mantle cell lymphoma. (GELTAMO-RGemOx)
Time frame: 3 years and 2 months
To identify clinical response predictive factors
Time frame: 3 years 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2017.
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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.
Andrés López Hernández, MD principal investigator
Hospital Vall d´Hebrón
Mª Dolores Caballero Barrigón, MD principal investigator
Hospital Clínico de Salamanca
Jorge Gayoso Cruz, MD principal investigator
Hospital Universitario Gregorio Marañón
28 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Rituximab, Gemcitabine, Oxaliplatin, Dexametasone in people with Aggressive Lymphoma and Diffuse Large B-cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 28 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 4 inclusion and 7 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 30 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 28 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary endpoint is to evaluate Overall response rate (ORR) (time frame: 3 years and 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2017; AzTrials last refreshed its copy on 6 Nov 2026.