Mantle-cell LymphomaPhase 2MAN2NCT02267915
Phase II of Efficacy and Toxicity of Maintenance Sub. Rituximab After Induction in Relapsed MCL and Non-eligible HSCT
A Phase 2 study testing subcutaneous Rituximab in people with Mantle-cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 15 sites in Spain.
Trial summary
1. Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy 2. Secondary endpoints: 1. Quality of response obtained after subcutaneous Rituximab maintenance. 2. Progression-Free Survival (PFS) 3. Overall Survival (OS) 4. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mantle-cell Lymphoma
- What is being tested?
- subcutaneous Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 15 sitesSpain
- Study dates
- Mar 2015to Feb 2020
- 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
- Basal diagnosis of mantle-cell lymphoma in relapse or refractory.
- Achievement of a CR or PR after salvage therapy with R-GemOxD (6 to 8 cycles) as previously described4-5.
- Age > 18 years.
- One or maximum two prior chemotherapy or immunochemotherapy lines.
- Patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation.
- No clinical evidence of CNS involvement
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- Signed informed consent
- Serum creatinine less than 2 and/or bilirrubin less than 2.5 UNL.
- Pregnant or lactating woman. FCBP must agree to ongoing pregnancy testing during the course or study and commit to use effective contraception during the study
Who cannot join
- Prior organ transplantation.
- HIV positive.
- HBV related disease
- Any serious active disease or co-morbid medical condition (according to the investigator's decision)
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma.
- Less than 50% of tumor response.
- Platelet counts less than 50 x 109/L.
- Neutrophil counts less than 1.0 x 109/L.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Spain15 sites
Geltamo Investigational Site
Alcorcón, Madrid, 28922
Geltamo Investigational Site
Barcelona, 08003
Geltamo Investigational Site
Barcelona, 08035
Geltamo Investigational Site
Barcelona, 08036
Geltamo Investigational Site
Barcelona, 08041
Geltamo Investigational Site
Barcelona, 08916
Geltamo Investigational Site
Burgos, 09006
Geltamo Investigational Site
Gijón, Principality of Asturias, 33394
Geltamo Investigational Site
Granada, 18014
Geltamo Investigational Site
Madrid, 28031
Geltamo Investigational Site
Majadahonda, Madrid, 28222
Geltamo Investigational Site
Salamanca, 37007
Geltamo Investigational Site
Santander, 39008
Geltamo Investigational Site
Santiago de Compostela, LA Coruña, 15706
Geltamo Investigational Site
Seville, 41013
About this study
Official title: An Open Multicenter Phase II Study of Efficacy and Toxicity of Maintenance Subcut. Rituximab After Induction With Rituximab in Patients With Relapsed or Refractory Mantle-cell Lymphoma Non-eligible for HSCT
- Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy
- Secondary endpoints:
- Quality of response obtained after subcutaneous Rituximab maintenance.
- Progression-Free Survival (PFS)
- Overall Survival (OS)
- Time to Next Therapy (TTNT)
- Value of MRD in the disease outcome
- Toxicity
Read the detailed description
This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOx-D.
Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles.
Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.
Patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. More details in Appendix 1 (Schedule of Assessments)
- Conditions
- Mantle-cell Lymphoma
- Being tested
- subcutaneous Rituximab
- Keywords
- Relapsed or refractory patients with mantle-cell lymphoma, Progression after high-dose chemotherapy and autologous HPT
- Medical subject headings
- Lymphoma, Mantle-Cell, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subcutaneous RituximabDrug
Also called MABTHERA
MabThera 1400 mg solution for subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| subcutaneous rituximab | Experimental | MabThera 1400 mg solution for subcutaneous injection Receives: Drug: subcutaneous Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)
2 years after last patient randomized in maintenance
Measured: 2 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2014 (estimated)
- Study startMar 2015
- Primary completionDec 2019
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mantle-cell 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andres Lopez, DOCTOR, Study director, Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02267915
- Sponsor's protocol ID
- GELTAMO-MAN2
- Acronym
- MAN2
- Status last verified
- May 2019
- First submitted
- 3 Oct 2014
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Multicenter Phase II Study of Efficacy and Toxicity of Maintenance Subcut. Rituximab After Induction With Rituximab in Patients With Relapsed or Refractory Mantle-cell Lymphoma Non-eligible for HSCT
- ClinicalTrials.gov ID
- NCT02267915
- Acronym / sponsor ID
- MAN2 / GELTAMO-MAN2
- Conditions
- Mantle-cell Lymphoma
- Keywords
- Relapsed or refractory patients with mantle-cell lymphoma, Progression after high-dose chemotherapy and autologous HPT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Grupo Español de Linfomas y Transplante Autólogo de Médula ÓseaUniversity, hospital or other
- Study start
- Mar 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Feb 2020 (estimated)
- First posted
- 20 Oct 2014 (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.
- Primary endpoint: Time to relapse/progression (TTP) after achieving a complete or partial response with the (R-GemOxD)-induction therapy
- Secondary endpoints:
- Quality of response obtained after subcutaneous Rituximab maintenance.
- Progression-Free Survival (PFS)
- Overall Survival (OS)
- Time to Next Therapy (TTNT)
- Value of MRD in the disease outcome
- Toxicity
Detailed description
This is a phase II trial evaluating the role of maintenance with subcutaneous Rituximab in patients with stage II-IV relapsed or refractory mantle-cell lymphoma with complete or partial response after the administration of a salvage regimen with R-GemOx-D.
Before the study start and in order to standardize the results, the same R-GemOx-D salvage regimen will be used: Rituximab: 375 mg/m2 on day 1, Gemcitabine: 1000 mg/m2 on day 2 (over 30 minutes) and Oxaliplatin: 100 mg/m2 on day 2 (over 3 hours), Dexamethasone 20 mg on day 1-3. Cycles should be repeated every 14 days, up to 8 cycles.
Patients who present a complete or partial response, after the salvage therapy, will start the study receiving subcutaneous Rituximab maintenance at dose of: 1400 mg every 2 months for 2 years; the study treatment will start 6-8 weeks after finishing the salvage therapy.
Patients will be evaluated every 2 months during treatment study phase and every 4 months in the follow up phase. More details in Appendix 1 (Schedule of Assessments)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subcutaneous rituximab | Experimental | Drug: subcutaneous RituximabMabThera 1400 mg solution for subcutaneous injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Basal diagnosis of mantle-cell lymphoma in relapse or refractory.
- Achievement of a CR or PR after salvage therapy with R-GemOxD (6 to 8 cycles) as previously described4-5.
- Age > 18 years.
- One or maximum two prior chemotherapy or immunochemotherapy lines.
- Patients should not be considered candidates for high-dose chemotherapy and autologous stem-cell transplantation.
Key exclusion criteria (8 listed)
- Prior organ transplantation.
- HIV positive.
- HBV related disease
- Any serious active disease or co-morbid medical condition (according to the investigator's decision)
- Any history of cancer during the last 5 years, with the exception of non-melanoma skin tumors or stage 0 cervix carcinoma.
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 |
|---|---|---|
| subcutaneous RituximabAlso: MABTHERAMabThera 1400 mg solution for subcutaneous injection | Drug | subcutaneous rituximab |
Primary outcome
Time to progression, (Measured from achievement of response -partial or complete- to to disease progression)
Time frame: 2 YEARS
2 years after last patient randomized in maintenance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
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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.
Andres Lopez, DOCTOR study director
Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea
15 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 subcutaneous Rituximab in people with Mantle-cell Lymphoma, run by Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea at 15 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 9 inclusion and 8 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 27 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Time to progression, (Measured from achievement of response -partial or complete- to to disease progression) (time frame: 2 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 27 Jan 2020.