Indolent LymphomaPhase 1/2R-GONCT00954005
Study With Rituximab-Gemcitabine/Oxaliplatin in Relapsed Indolent Lymphoma
A Phase 1/2 study testing Therapy with Rituximab, Gemcitabine and Oxaliplatin in people with Indolent Lymphoma, run by German Low Grade Lymphoma Study Group at 1 site in Germany.
Trial summary
The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Indolent Lymphoma
- What is being tested?
- Therapy with Rituximab, Gemcitabine and Oxaliplatin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2003to Jun 2012
- Phase
- Phase 1/2
- 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
- Need for therapy in patients with relapsed/refractory patients
- Histological proven diagnosis of an indolent B-cell lymphoma according to the World Health Organization (WHO) classification belonging to one of the following entities:
- follicular lymphoma
- mantle cell lymphoma
- lymphoplasmacytic lymphoma
- nodal or splenic marginal zone lymphoma
Show all 9Show fewer
- measurable disease
- lymphoma specific therapy in the last four weeks
- WHO performance grade 0, 1 or 2
Who cannot join
- Patients suitable for high dose therapy
- Transformation in high grade lymphoma
- Leukocytes < 1,5/nl or platelets < 100/nl (except due to lymphoma)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma
The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.
- Conditions
- Indolent Lymphoma
- Being tested
- Therapy with Rituximab, Gemcitabine and Oxaliplatin
- Keywords
- relapsed indolent lymphoma, gemcitabine, oxaliplatin, rituximab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapy with Rituximab, Gemcitabine and OxaliplatinDrug
Also called Rituximab = Mabthera, Rituxan, Gemcitabine = Gemzar, Oxaliplatin = Eloxatin
Rituximab 375 mg/m² day 0 or 1, Gemcitabine 1.000 mg/m² in 30 Min. day 1 and 15, Oxaliplatin 70 mg/m² in 120 Min. day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²), repetition at day 29 for 4 cycles
| Study group | Role | What they receive |
|---|---|---|
| Rituximab, Gemcitabine and Oxaliplatin | Experimental | Drug: Rituximab on day 0 or 1 of each 28-day cycle Drug: Gemcitabine on day 1 and 15 of each 28-day cycle Drug: Oxaliplatin on day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²) of each 28-day cycle Receives: Drug: Therapy with Rituximab, Gemcitabine and Oxaliplatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Remission Rate
Measured: end of therapy
Secondary outcomes (3)
Progression Free Survival
Measured: 5 years
Median Overall Survival
Measured: 5 years
Toxicity
Number of Participants With Treatment-Related Adverse Events as Assessed by WHO Toxicity Grading Scale
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startJan 2003
- Primary completionJun 2011
- Study completionJun 2012
Why it stopped: Predefined termination criterion of \> 10 patients without CR or PR was matched.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Indolent 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- German Low Grade Lymphoma Study Group
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Hoffmann, German Low Grade Lymphoma Study Group
- Investigators
- Martin Hoffmann, Dr., Principal investigator, German Low Grade Lymphoma Study Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954005
- Sponsor's protocol ID
- 001
- Acronym
- R-GO
- Status last verified
- Aug 2015
- First submitted
- 4 Aug 2009
- Last updated
- 19 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Scheubeck G, Hoffmann M, Jurinovic V, Fischer L, Unterhalt M, Schmidt C, Bock HP, Duhrsen U, Kaesberger J, Kremers S, Lindemann HW, Mantovani L, Hiddemann W, Hoster E, Dreyling M; German Lymphoma Alliance (GLA). Rituximab, gemcitabine and oxaliplatin in relapsed or refractory indolent and mantle cell lymphoma: results of a multicenter phase I/II-study of the German Low Grade Lymphoma Study Group. Ann Hematol. 2024 Jul;103(7):2373-2380. doi: 10.1007/s00277-024-05689-w. Epub 2024 Mar 9.
PubMed 38459156
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Phase I/II Study for the Efficacy of a Combination of Rituximab, Gemcitabine and Oxaliplatin in Relapsed/Refractory Indolent Lymphoma
- ClinicalTrials.gov ID
- NCT00954005
- Acronym / sponsor ID
- R-GO / 001
- Conditions
- Indolent Lymphoma
- Keywords
- relapsed indolent lymphoma, gemcitabine, oxaliplatin, rituximab
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Predefined termination criterion of \> 10 patients without CR or PR was matched.
- Enrolment
- 56 participants (actual)
- Lead sponsor
- German Low Grade Lymphoma Study GroupUniversity, hospital or other
- Study start
- Jan 2003
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 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.
The purpose of the phase I part is to determine the tolerability, the initial safety profile and maximum tolerated dose of oxaliplatin in combination with gemcitabine for indolent lymphoma. In the phase II part the investigators want to estimate the activity of gemcitabine and oxaliplatin in combination with rituximab for patients with relapsed/refractory indolent lymphoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab, Gemcitabine and Oxaliplatin | Experimental | Drug: Therapy with Rituximab, Gemcitabine and OxaliplatinDrug: Rituximab on day 0 or 1 of each 28-day cycle Drug: Gemcitabine on day 1 and 15 of each 28-day cycle Drug: Oxaliplatin on day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²) of each 28-day cycle |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Need for therapy in patients with relapsed/refractory patients
- Histological proven diagnosis of an indolent B-cell lymphoma according to the World Health Organization (WHO) classification belonging to one of the following entities:
Key exclusion criteria (3 listed)
- Patients suitable for high dose therapy
- Transformation in high grade lymphoma
- Leukocytes < 1,5/nl or platelets < 100/nl (except due to lymphoma)
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 |
|---|---|---|
| Therapy with Rituximab, Gemcitabine and OxaliplatinAlso: Rituximab = Mabthera, Rituxan, Gemcitabine = Gemzar, Oxaliplatin = EloxatinRituximab 375 mg/m² day 0 or 1, Gemcitabine 1.000 mg/m² in 30 Min. day 1 and 15, Oxaliplatin 70 mg/m² in 120 Min. day 1 and 15 (in phase 1 dose escalation of Oxaliplatin in steps of 10 mg/m²), repetition at day 29 for 4 cycles | Drug | Rituximab, Gemcitabine and Oxaliplatin |
Primary outcome
Overall Remission Rate
Time frame: end of therapy
3 secondary outcomes
Progression Free Survival
Time frame: 5 years
Median Overall Survival
Time frame: 5 years
Toxicity
Time frame: 5 years
Results and safety
The study was stopped early (reason given: Predefined termination criterion of \> 10 patients without CR or PR was matched.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2015.
- Derived from this study: PubMed 38459156Scheubeck G, Hoffmann M, Jurinovic V, Fischer L, Unterhalt M, Schmidt C, Bock HP, Duhrsen U, Kaesberger J, Kremers S, Lindemann HW, Mantovani L, Hiddemann W, Hoster E, Dreyling M; German Lymphoma Alliance (GLA). Rituximab, gemcitabine and oxaliplatin in relapsed or refractory indolent and mantle cell lymphoma: results of a multicenter phase I/II-study of the German Low Grade Lymphoma Study Group. Ann Hematol. 2024 Jul;103(7):2373-2380. doi: 10.1007/s00277-024-05689-w. Epub 2024 Mar 9.
- web site in german languageLink provided by the sponsor.
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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.
Martin Hoffmann, Dr. principal investigator
German Low Grade Lymphoma Study Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Therapy with Rituximab, Gemcitabine and Oxaliplatin in people with Indolent Lymphoma, run by German Low Grade Lymphoma Study Group at 1 site in Germany.
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 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: stopped early, as of the sponsor's last update on 19 Aug 2015. 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 Germany. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 was stopped early (reason given: Predefined termination criterion of \> 10 patients without CR or PR was matched.). 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?
Overall Remission Rate (time frame: end of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00954005, which also lists 1 linked publication.
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 19 Aug 2015.