Non-Hodgkin's LymphomaPhase 2NCT00337259
Gemcitabine for Marginal Zone Lymphoma
A Phase 2 study testing gemcitabine in people with Non-Hodgkin's Lymphoma and Marginal Zone Lymphoma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma
- What is being tested?
- gemcitabine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2006to Mar 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed marginal zone B-cell lymphoma
- Performance status (ECOG) ≤3
- Age ≥ 18
- At least one or more bidimensionally measurable lesion(s):
- 2 cm by conventional CT
- 1 cm by spiral CT
Show all 15Show fewer
- skin lesion (photographs should be taken)
- measurable lesion by physical examination
- Laboratory values:
- Cr < 2.0 mg% or Ccr > 60 ml/min
- Transaminase < 3 X upper normal value
- Bilirubin < 2 mg%
- ANC > 1500/ul, platelet > 75,000/ul
- Informed consent
- Ann Arbor stage III or IV
Who cannot join
- Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
- Serious comorbid diseases
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.
Read the detailed description
We designed a multi-center phase II trial of gemcitabine for advanced stage marginal zone B-cell lymphoma. Marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. Recent trials with new agents for indolent lymphoma shows promising results. Gemcitabine is known to have activity to non-Hodgkin's lymphoma and has less adverse effects than other new agents. With this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma.
Gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria.
- Conditions
- Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma
- Being tested
- gemcitabine
- Keywords
- marginal zone lymphoma, gemcitabine
- Medical subject headings
- Lymphoma, Non-Hodgkin, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabineDrug
D1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine | Experimental | * histologically confirmed marginal zone lymphoma
* gemcitabine 1,250 mg/m2 on days 1 and 8 of each cycle, repeated every 3 weeks and continued for 6 cycles, until disease progression, withdrawal due to toxicity, or withdrawal of consent. Receives: Drug: gemcitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
response rate
Measured: CR+PR with study therapy
Secondary outcomes (1)
safety and tolerability of the treatment
Measured: toxicity due to stdy drug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionMar 2009
- Study completionMar 2009
Why it stopped: poor accrual and response less than expected on interim analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Hodgkin's 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
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Responsible party
- Principal investigator, Cheolwon Suh, Asan Medical Center
- Investigators
- Cheolwon Suh, MD, PhD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00337259
- Sponsor's protocol ID
- AMC 2006-60
- Status last verified
- Feb 2016
- First submitted
- 14 Jun 2006
- Last updated
- 17 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Gemcitabine in Patients With Advanced Stage Marginal Zone B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT00337259
- Acronym / sponsor ID
- AMC 2006-60
- Conditions
- Non-Hodgkin's Lymphoma, Marginal Zone Lymphoma
- Keywords
- marginal zone lymphoma, gemcitabine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual and response less than expected on interim analysis
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Jun 2006
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 15 Jun 2006 (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.
Marginal zone lymphoma, one of the indolent lymphoma, is believed to be incurable with chemotherapy. Thus the investigators need a novel agent for marginal zone lymphoma. Gemcitabine has been tried as one of salvage chemotherapy regimen and has been shown to have anti-lymphoma activity. To the investigators' knowledge, there has been no trial of gemcitabine for marginal zone lymphoma. Thus the investigators made a plan to investigate the role of gemcitabine in marginal zone lymphoma.
Detailed description
We designed a multi-center phase II trial of gemcitabine for advanced stage marginal zone B-cell lymphoma. Marginal zone lymphoma needs novel agent to improve clinical course by chemotherapy. Recent trials with new agents for indolent lymphoma shows promising results. Gemcitabine is known to have activity to non-Hodgkin's lymphoma and has less adverse effects than other new agents. With this background gemcitabine will be tried as a single agent for advanced marginal zone lymphoma.
Gemcitabine will be administered with 1,250mg/sq.m on days 1 and 8 every 3 weeks. Response will be assessed by IWC criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine | Experimental | Drug: gemcitabine* histologically confirmed marginal zone lymphoma * gemcitabine 1,250 mg/m2 on days 1 and 8 of each cycle, repeated every 3 weeks and continued for 6 cycles, until disease progression, withdrawal due to toxicity, or withdrawal of consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically confirmed marginal zone B-cell lymphoma
- Performance status (ECOG) ≤3
- Age ≥ 18
- At least one or more bidimensionally measurable lesion(s):
- Laboratory values:
Key exclusion criteria (3 listed)
- Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
- Serious comorbid diseases
- Pregnancy or breast feeding
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 |
|---|---|---|
| gemcitabineD1 and 8, Gemcitabine 1250mg/m2 + NS 100ml MIV over 30min, every 3 weeks | Drug | Gemcitabine |
Primary outcome
response rate
Time frame: CR+PR with study therapy
1 secondary outcome
safety and tolerability of the treatment
Time frame: toxicity due to stdy drug
Results and safety
The study was stopped early (reason given: poor accrual and response less than expected on interim analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2016.
- Individual participant dataSharing planned: No
Related trials for Non-Hodgkin's Lymphoma
RecruitingPhase 1/2
Venetoclax, Ibrutinib, Prednisone, Obinutuzumab, and Revlimid (ViPOR) in Relapsed/Refractory B-cell Lymphoma
Lymphoma, Non-Hodgkin Lymphoma
Active, not recruitingPhase 1/2
Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas
Anaplastic Large Cell Lymphoma, Nodal Peripheral T-Cell Lymphoma With TFH Phenotype
RecruitingObservational study
Collection of Human Samples to Study Hairy Cell and Other Leukemias, and to Develop Recombinant Immunotoxins for Cancer Treatment
Hairy Cell Leukemia (HCL), Chronic Lymphocytic Leukemia (CLL)
Active, not recruitingPhase 1
Copanlisib and Nivolumab in Treating Patients With Richter's Transformation or Transformed Indolent Non-Hodgkin Lymphoma
Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma
RecruitingPhase 1
Study of ALA-101 in Patients With CD19 Positive Non-Hodgkin Lymphoma and Leukemia.
Non Hodgkin Lymphoma (NHL), Leukaemia
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.
Cheolwon Suh, MD, PhD principal investigator
Asan Medical Center
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 gemcitabine in people with Non-Hodgkin's Lymphoma and Marginal Zone Lymphoma, run by Asan Medical Center at 1 site in South Korea.
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 15 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 17 Feb 2016. 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 South Korea. 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 was stopped early (reason given: poor accrual and response less than expected on interim analysis). 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?
response rate (time frame: CR+PR with study therapy). 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 17 Feb 2016.