B-Cell LymphomaPhase 2NCT00965289
High-dose Chemotherapy With Rituximab for Adults With Aggressive Large B-cell Lymphoma
A Phase 2 study testing Rituximab in people with B-Cell Lymphoma, run by Nantes University Hospital at 1 site in France.
Trial summary
A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- B-Cell Lymphoma
- What is being tested?
- Rituximab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2002to Jun 2009
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 y.o
- Aggressive Large B-Cell Lymphoma (CD20+)
- Ann Arbor stage III, IV
- IH or high adjusted IPI
- signed inform consent
Who cannot join
- Age < 18 ou > 60 y.o
- other type of lymphoma
- serology VIH +
- other neoplasms apart from basal cell carcinoma or situ carcinoma
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.
A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.
Read the detailed description
Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.
- Conditions
- B-Cell Lymphoma
- Being tested
- Rituximab
- Keywords
- Aggressive large B-cell lymphoma (DLBCL), Intensive chemotherapy, Rituximab, ASCT
- Medical subject headings
- Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RituximabDrug
Also called Mabthera®
Rituximab infusion on day 1 dose: 375mg/m²
| Study group | Role | What they receive |
|---|---|---|
| HDT combined with rituximab before ASCT | Experimental | The study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen. Receives: Drug: Rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
CR rate after 3 high dose chemotherapy courses
Measured: safety/efficacy of chemotherapy treatment
Secondary outcomes (3)
CR and PR rate at the end of the study treatment
Measured: safety/efficacy of treatment30 days after the end of post ASCT aplasia
PFS,EFS and OS
Measured: safety/efficacy of study treatment
Tolerance of Rituximab combined with chemotherapy
Measured: safety/efficacy of immunotherapy combined with chemotherapy treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startApr 2002
- Primary completionMay 2003
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-Cell LymphomaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- French Innovative Leukemia Organisation, Hoffmann-La Roche
- Investigators
- Noel MILPIED, PD MS, Principal investigator, CHU NANTES/GOELAMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965289
- Sponsor's protocol ID
- GOELAMS 074
- Status last verified
- Aug 2009
- First submitted
- 24 Aug 2009
- Last updated
- 26 Aug 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Front-line High-dose Chemotherapy (HDT) Combined With Rituximab for Adults With Aggressive Large B-cell Lymphoma (DLBCL) : Goelams 074 Trial.
- ClinicalTrials.gov ID
- NCT00965289
- Acronym / sponsor ID
- GOELAMS 074
- Conditions
- B-Cell Lymphoma
- Keywords
- Aggressive large B-cell lymphoma (DLBCL), Intensive chemotherapy, Rituximab, ASCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- French Innovative Leukemia Organisation, Hoffmann-La Roche
- Study start
- Apr 2002
- Primary completion
- May 2003 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 25 Aug 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.
A prospective pilot trial was proposed to patients with DLBCL, with IH or high adjusted IPI, up to the age of 60 y.o. This program consisted of 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen.
Detailed description
Superiority of HDT with autologous stem cell transplantation (ASCT) in the upfront treatment of poor-risk DLBCL remains an option for intermediate-high (IH) or high IPI young adults. We updated results of the prospective trial Goelams 074 to evaluate long-term efficacy and toxicity in 42 patients who underwent HDT with ASCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HDT combined with rituximab before ASCT | Experimental | Drug: RituximabThe study treatment consisted on 2 courses of high-dose R-CHOP-like regimen, followed by a course of high-dose methotrexate with cytarabin. For patients who achieved at least a PR, ASCT started with a BEAM regimen. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18 to 60 y.o
- Aggressive Large B-Cell Lymphoma (CD20+)
- Ann Arbor stage III, IV
- IH or high adjusted IPI
- signed inform consent
Key exclusion criteria (4 listed)
- Age < 18 ou > 60 y.o
- other type of lymphoma
- serology VIH +
- other neoplasms apart from basal cell carcinoma or situ 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 |
|---|---|---|
| RituximabAlso: Mabthera®Rituximab infusion on day 1 dose: 375mg/m² | Drug | HDT combined with rituximab before ASCT |
Primary outcome
CR rate after 3 high dose chemotherapy courses
Time frame: safety/efficacy of chemotherapy treatment
3 secondary outcomes
CR and PR rate at the end of the study treatment
Time frame: safety/efficacy of treatment30 days after the end of post ASCT aplasia
PFS,EFS and OS
Time frame: safety/efficacy of study treatment
Tolerance of Rituximab combined with chemotherapy
Time frame: safety/efficacy of immunotherapy combined with chemotherapy treatment
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 26 Aug 2009.
Related trials for B-Cell Lymphoma
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Study of Oral MRT-2359 in Selected Cancer Patients
NSCLC, SCLC
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
A Study of Anakinra to Prevent or Treat Severe Side Effects for Patients Receiving CAR-T Cell Therapy
B Cell ALL, B-Cell Lymphoma
Active, not recruitingEarly Phase 1
Iomab-ACT: A Pilot Study of 131-I Apamistamab Followed by CD19-Targeted CAR T-Cell Therapy for Patients With Relapsed or Refractory B-Cell Acute Lymphoblastic Leukemia or Diffuse Large B-Cell Lymphoma
B-ALL, DLBCL
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.
Noel MILPIED, PD MS principal investigator
CHU NANTES/GOELAMS
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 in people with B-Cell Lymphoma, run by Nantes University Hospital 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 5 inclusion and 4 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 26 Aug 2009. 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?
CR rate after 3 high dose chemotherapy courses (time frame: safety/efficacy of chemotherapy treatment). 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 26 Aug 2009.