Diffuse Large B-Cell LymphomaPhase 2NCT00842595
Efficacy , Safety of Treatment R NIMP for Relapsed Aggressive Lymphomas
A Phase 2 study testing rituximab, vinorelbine and ifosfamide in people with Diffuse Large B-Cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
Trial summary
The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Large B-Cell Lymphoma
- What is being tested?
- rituximab, vinorelbine and ifosfamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2003to May 2010
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both genders, between 18 and 75 years old
- CD 20+ large cell lymphoma
- In first relapse
- No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation
- Ann Arbor stage I, II, III ou IV
- ECOG 0,1 or 2
- Signed informed consent
Who cannot join
- age: before 18 and more than 75 years old
- other type of lymphoma
- Informed consent not signed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Treatment of Relapsed Agressive Lymphomas
The primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma
Read the detailed description
Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.
The study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy).
The addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival.
Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs.
Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.
- Conditions
- Diffuse Large B-Cell Lymphoma
- Being tested
- rituximab, vinorelbine, ifosfamide, Mitoxantrone, Prednisone
- Keywords
- relapsed aggressive B-cell lymphoma, Chemotherapy
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rituximabDrug
Also called (Mabthera ® )Rituximab IV 375 mg/m²day
6 courses every 28 days
vinorelbineDrug
Also called (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 5
6 courses every 28 days
ifosfamideDrug
Also called (Holoxan®)Ifostamide 1000mg/m² day 1 to day 5
6 courses every 28 days
MitoxantroneDrug
Also called (Novantrone®) Mitoxantrone 10mg/m² day1
6 courses every 28 days
PrednisoneDrug
Also called (Cortancyl®)Prednisone 1m/kg day 1 to day 5
6 courses every 28 days
| Study group | Role | What they receive |
|---|---|---|
| R NIMP | Experimental | (Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5 Receives: Drug: rituximab; Drug: vinorelbine; Drug: ifosfamide; Drug: Mitoxantrone; Drug: Prednisone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete remission rate
Measured: CR AFTER 3 R NIMP COURSES
Secondary outcomes (3)
overall remission rate
Measured: OS after 3 R NIMP COURSES
Toxicity
Measured: R NIMP TOLERANCE
Pharmacoeconomy
Measured: treatment phramacoeconomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startDec 2003
- Primary completionNov 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diffuse Large B-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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel GYAN, Principal investigator, French Innovative Leukemia Organisation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842595
- Sponsor's protocol ID
- R NIMP
- Status last verified
- Jul 2010
- First submitted
- 11 Feb 2009
- Last updated
- 24 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Treatment of Relapsed Agressive Lymphomas
- ClinicalTrials.gov ID
- NCT00842595
- Acronym / sponsor ID
- R NIMP
- Conditions
- Diffuse Large B-Cell Lymphoma
- Keywords
- relapsed aggressive B-cell lymphoma, Chemotherapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 Feb 2009 (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 primary objective of the protocol is to estimate the complete response rate of three courses of the association of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma
Detailed description
Phase II study of the efficacy and toxicity of rituximab, navelbine, ifosfamide, mitoxantrone, and prednisone in relapsed aggressive non hodgkin's B-cell lymphoma.
The study intervention is an administration of 3 courses of the abovementioned drugs, witch doses are detailed below. Remission is assessed and the investigator is free to proceed with any kind of consolidation , he decides best for the patient( high dose or standard chemotherapy).
The addition of Rituximab the the NIMP protocol is warranted on the basis of previous publications wtich have shown a significant advantage in addition to chemotherapy in complete remission rate and in overall survival.
Navelbine has shown an interesting activity in lymphoma relapse. Mitoxantrone has a good toxicity profile for patients who have prevously received anthracyclines, and there is not so much cross resistance between the two drugs.
Ifosfamide is commonly used in the treatment of relapsed and refractory lymphoma, because of its low hematologic toxicity profile and good antitumor activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R NIMP | Experimental | Drug: rituximab, Drug: vinorelbine, Drug: ifosfamide, Drug: Mitoxantrone, Drug: Prednisone(Mabthera®) Rituximab IV 375 mg/m²day 1 (Navelbine ®)Vinorelbine IV 25mg/m² day 1 and day 5 (Novantrone®)Mitoxantrone IV 10 mg/m² day 1 (Holoxan®)Ifostamide IV 1000 mg/m²day 1 to day 5 (Cortancyl®)prednisone oral day 1 to day 5 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both genders, between 18 and 75 years old
- CD 20+ large cell lymphoma
- In first relapse
- No previous autologous stem cell transplantation or relapsing more than 12 months after an autologous stem cell transplantation
- Ann Arbor stage I, II, III ou IV
Key exclusion criteria (3 listed)
- age: before 18 and more than 75 years old
- other type of lymphoma
- Informed consent not signed
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 |
|---|---|---|
| rituximabAlso: (Mabthera ® )Rituximab IV 375 mg/m²day6 courses every 28 days | Drug | R NIMP |
| vinorelbineAlso: (Navelbine ®) Vinorelbine IV 25mg/m² day 1 and day 56 courses every 28 days | Drug | R NIMP |
| ifosfamideAlso: (Holoxan®)Ifostamide 1000mg/m² day 1 to day 56 courses every 28 days | Drug | R NIMP |
| MitoxantroneAlso: (Novantrone®) Mitoxantrone 10mg/m² day16 courses every 28 days | Drug | R NIMP |
| PrednisoneAlso: (Cortancyl®)Prednisone 1m/kg day 1 to day 56 courses every 28 days | Drug | R NIMP |
Primary outcome
Complete remission rate
Time frame: CR AFTER 3 R NIMP COURSES
3 secondary outcomes
overall remission rate
Time frame: OS after 3 R NIMP COURSES
Toxicity
Time frame: R NIMP TOLERANCE
Pharmacoeconomy
Time frame: treatment phramacoeconomy
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 24 Jul 2013.
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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.
Emmanuel GYAN principal investigator
French Innovative Leukemia Organisation
1 site 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, vinorelbine and ifosfamide in people with Diffuse Large B-Cell Lymphoma, run by French Innovative Leukemia Organisation at 1 site in France.
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 7 inclusion and 3 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 24 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
Complete remission rate (time frame: CR AFTER 3 R NIMP COURSES). 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 24 Jul 2013.