Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.Phase 2NCT01127841
Trial of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line
A Phase 2 study testing Rituximab and Bendamustine in people with Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line., run by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas at 18 sites in Spain.
Trial summary
Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
- What is being tested?
- Rituximab and Bendamustine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 18 sitesSpain
- Study dates
- Jul 2009to Dec 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.
- Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue.
- Follicular lymphoma patients previously treated with the combination of rituximab and chemotherapy (R-CHOP, R-CVP, R-fludarabine), having received rituximab maintenance, refractory to a first line (excluding radiotherapy) or relapsed after having achieved any response to previous treatment.
- ECOG ≤ 2.
- Signed written informed consent
Who cannot join
- Clinical suspicion or documentation of histological transformation.
- Patients with hypersensitivity to rituximab.
- Prior autologous or allogeneic transplant.
- 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 severe immunosuppression.
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- Previous neoplasms except non-melanoma skin cancer of the cervix or adequately treated.
- Congestive heart failure> NYHA grade 1.
- Impaired renal function (creatinine> 1.5 x Upper Limit of Normal, ULN) or 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.
- 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
18 sites in 1 country.
18 sites in 1 country
Spain18 sites
Hospital G. U. de Alicante
Alicante, Alicante
Hospital Insular de Gran Canarias
Canarias, Canary Islands
Hospital U. de Gran Canarias Dr. Negrín
Canarias, Canary Islands
Instituto Oncologico de San Sebastian
Donostia / San Sebastian, San Sebastian
Hospital de Elche
Elche, Alicante
Hospital uan Ramón Jiménez
Huelva, Huelva
Hospital San Pedro de La Rioja
Logroño, La Rioja
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid
Hospital Universitario Virgen de la Victoria
Málaga
Hospital Son Dureta
Mallorca, Mallorca
Hospital Costa del Sol
Marbella, Malaga
Complejo Hospitalario de Pontevedra
Pontevedra, Pontevedra
Hospital Sant Joan de Reus
Reus, Tarragona
Hospital Universitario de Canarias
Santa Cruz de Tenerife, Tenerife
Hospital Virgen de la Macarena
Seville, Sevilla
Hospital Virgen de la Salud
Toledo, Toledo
Hospital General de Valencia
Valencia, Valencia
Hospital Universitario La Fe
Valencia, Valencia
About this study
Official title: Study Phase II Non-randomized Prospective Open to Assess the Combination of Rituximab, Bendamustine (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.
- Being tested
- Rituximab and Bendamustine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab and BendamustineDrug
Rituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv.
| Study group | Role | What they receive |
|---|---|---|
| Rituximab and Bendamustine | Experimental | Not described Receives: Drug: Rituximab and Bendamustine |
What is being measured
The primary outcome is the main question the study is designed to answer.
the primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
Evaluation of response to induction treatment at 6 months after inclusion of the patient. Evaluation of response to maintenance treatment at 2 years after finishing the induction treatment.
Measured: Four years
Secondary outcomes (1)
Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.
Measured: Four years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJul 2009
- Primary completionDec 2013 (estimated)
- Study completionDec 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.Studies 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01127841
- Sponsor's protocol ID
- GOTEL/09-01
- Status last verified
- Aug 2013
- First submitted
- 18 Mar 2010
- Last updated
- 23 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2013. 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 (RB) for Patients With Follicular Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line.
- ClinicalTrials.gov ID
- NCT01127841
- Acronym / sponsor ID
- GOTEL/09-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Grupo Oncológico para el Tratamiento y el Estudio de los LinfomasUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 21 May 2010 (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.
Evaluate the effectiveness of rituximab, bendamustine (r) in terms of complete response and response complete not confirmed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab and Bendamustine | Experimental | Drug: Rituximab and Bendamustine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Patients with follicular lymphoma grade 1, 2 or 3a, CD20 +, histologically confirmed lymph node biopsy or tissue.
- Follicular lymphoma patients previously treated with the combination of rituximab and chemotherapy (R-CHOP, R-CVP, R-fludarabine), having received rituximab maintenance, refractory to a first line (excluding radiotherapy) or relapsed after having achieved any response to previous treatment.
- ECOG ≤ 2.
- Signed written informed consent
Key exclusion criteria (14 listed)
- Clinical suspicion or documentation of histological transformation.
- Patients with hypersensitivity to rituximab.
- Prior autologous or allogeneic transplant.
- 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 and BendamustineRituximab: 375 mg/m2/day, day 1 of each cycle, iv. Bendamustine: 90 mg/m2/day, days1 and 2 fo each cycle, iv. | Drug | Rituximab and Bendamustine |
Primary outcome
the primary endpoint is the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL
Time frame: Four years
Evaluation of response to induction treatment at 6 months after inclusion of the patient. Evaluation of response to maintenance treatment at 2 years after finishing the induction treatment.
1 secondary outcome
Secondary endpoint included an assessment of the following parameters:Global Survival,progression-Free survival,Disease-Free Survival,Duration of the Response.
Time frame: Four years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
18 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 and Bendamustine in people with Follicular Non-Hodgking´s Lymphoma Refractory or Relapsed After Treatment With R-chemotherapy in First Line., run by Grupo Oncológico para el Tratamiento y el Estudio de los Linfomas at 18 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 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: status not confirmed, as of the sponsor's last update on 23 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Results are not available in the source record.
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 the complete response and unconfirmed complete response according to the criteria of the International Workshop to Standardize Response Criteria for NHL (time frame: Four years). 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 23 Aug 2013.