B-cell LymphomasPhase 2NCT01068392
Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma(MZL)
A Phase 2 study testing Oxaliplatin, Prednisolone in people with B-cell Lymphomas, run by Dong-A University Hospital at 1 site in South Korea.
Trial summary
The investigators are willing to investigate the efficacy and safety of oxaliplatin and prednisolone (Ox-P) combination in patients with previously treated MZL who have a few clinical trial data. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- B-cell Lymphomas
- What is being tested?
- Oxaliplatin, Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2009to Sep 2014
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed marginal zone B-cell lymphomas
- Failure to achieve a clinical benefit (≥SD) with the initial treatment, or recurrent disease
- Performance status (ECOG) ≤2
- Age ≥ 20
- At least one or more bi-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
- Adequate kidney functions defined as; Cr < 2.0 mg% or Ccr > 60 ml/min
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- Adequate liver functions defined as; Transaminases < 3 X upper normal values; Bilirubin < 2 mg%
- Adequate bone marrow functions defined as; ANC > 1500/㎕, platelet > 75000/㎕
- Ann Arbor stage III or IV
- Ann Arbor stage I or II, which is not adequate for RT or surgical approach (e.g. multiple lung lesions, multiple colon involvement, remote abdominal LN with stomach involvement)
- Written informed consent approved by Institutional review board or Ethic committee
Who cannot join
- Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
- Serious co-morbid diseases
- Pregnancy or breast feeding
- Previous history of drug allergy to one of the drugs in the study regimen
- During this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II Study of Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma
The investigators are willing to investigate the efficacy and safety of oxaliplatin and prednisolone (Ox-P) combination in patients with previously treated MZL who have a few clinical trial data.
Read the detailed description
Over its long survival duration, MZL often involves frequent relapses. Overall, more than 50% of MZL patients experience a relapse within 10 years. However, Relapsed or refractory MZL represent a therapeutic dilemma in every day clinical practice and no prospective studies on large series have been published so far. The rarity of these disorders and some difficulties in the differential diagnosis from other low-grade lymphoma subtypes are obstacles in conducting epidemiological surveys and in properly describing clinical features and outcomes.
Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful antitumor activity with favourable toxicity profile.
In the previous phase II study of oxaliplatin for treatment of patients with mucosa-associated lymphoid tissue lymphoma, a total of 16 patients with MALT lymphoma of various sites of origin (four of the ocular adnexa, five of the salivary glands, three of the stomach, two of the lung, and one of the colon and the breast) were administered oxaliplatin at a dose of 130 mg/m2 infused during 2 hours every 3 weeks. Fifteen patients responded to chemotherapy, with nine achieving CR (56%), six (37.5%) achieving partial response, and one achieving stable disease; the median time to response was 4 months (range; 2 to 4 months).
Based upon the promising results of oxaliplatin regimen in refractory NHL and first-line treatment of MZL, The investigators are willing to investigate the efficacy and safety of oxaliplatin and prednisolone (Ox-P) combination in patients with previously treated MZL who have a few clinical trial data.
- Conditions
- B-cell Lymphomas
- Being tested
- Oxaliplatin, Prednisolone
- Keywords
- relapsed, marginal zone B-cell lymphoma, oxaliplatin, prednisolone
- Medical subject headings
- Lymphoma, B-Cell, Recurrence, Lymphoma, B-Cell, Marginal Zone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oxaliplatin, PrednisoloneDrug
OXALIPLATIN+PREDNISOLONE (OX-P)
D1 Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2hr
D1-5 Prednisolone 40-30-30 mg/day P.O
every 3 weeks
| Study group | Role | What they receive |
|---|---|---|
| OXP | Experimental | Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2HR D1 Prednisolone 100mg/Day D1-D5 Every 3 weeks Maximum 6 cycles of treatment will be given for this study. Subjects will be treated for at least 1 cycle and to a maximum of 6 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent. Receives: Drug: Oxaliplatin, Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate by International Working Group Response Criteria
Measured: 6 month after treatment
Secondary outcomes (2)
progression free survival
Measured: 3 year after start
overall survival
Measured: 5 year after start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2013
- Study completionSep 2014
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 B-cell LymphomasStudies 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
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dong-A University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center, Chung-Ang University, Kyungpook National University Hospital, Chonnam National University Hospital, Korea Cancer Center Hospital, Korea University
- Responsible party
- Principal investigator, Sung Yong Oh, Dong-A University Hospital
- Investigators
- Cheolwon Suh, M.D., Ph.D., Principal investigator, Asan Medical CenterSung Yong Oh, M.D., Ph.D., Study director, Dong-A University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01068392
- Sponsor's protocol ID
- CISL-MZL-10-3
- Status last verified
- Nov 2014
- First submitted
- 11 Feb 2010
- Last updated
- 4 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Oh SY, Kim WS, Kim JS, Chae YS, Lee GW, Eom HS, Ryoo HM, Lee S, Kim SJ, Yoon DH, Won JH, Hong J, Park J, Lee SM, Hong JY, Park E, Kim HJ, Yang DH, Kim HJ, Suh C. A phase II study of oxaliplatin and prednisone for patients with relapsed or refractory marginal zone lymphoma: Consortium for Improving Survival of Lymphoma trial. Leuk Lymphoma. 2016;57(6):1406-12. doi: 10.3109/10428194.2015.1099650. Epub 2015 Nov 16.
PubMed 26413982
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of Oxaliplatin and Prednisolone (Ox-P) for Patients With Relapsed or Refractory Marginal Zone B-cell Lymphoma
- ClinicalTrials.gov ID
- NCT01068392
- Acronym / sponsor ID
- CISL-MZL-10-3
- Conditions
- B-cell Lymphomas
- Keywords
- relapsed, marginal zone B-cell lymphoma, oxaliplatin, prednisolone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Dong-A University HospitalUniversity, hospital or other
- Collaborators
- Samsung Medical Center, Asan Medical Center, Chung-Ang University, Kyungpook National University Hospital, Chonnam National University Hospital, Korea Cancer Center Hospital, Korea University
- Study start
- Oct 2009
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 12 Feb 2010 (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 investigators are willing to investigate the efficacy and safety of oxaliplatin and prednisolone (Ox-P) combination in patients with previously treated MZL who have a few clinical trial data.
Detailed description
Over its long survival duration, MZL often involves frequent relapses. Overall, more than 50% of MZL patients experience a relapse within 10 years. However, Relapsed or refractory MZL represent a therapeutic dilemma in every day clinical practice and no prospective studies on large series have been published so far. The rarity of these disorders and some difficulties in the differential diagnosis from other low-grade lymphoma subtypes are obstacles in conducting epidemiological surveys and in properly describing clinical features and outcomes.
Oxaliplatin, a platinum coordination complex with an oxalato-ligand as the leaving group and a 1,2-diaminocyclohexane carrier, possesses higher cytotoxic potency on molar basis than cisplatin and carboplatin and was reported to be active in patients with NHL as a single agent. In addition, the substitution of cisplatin by oxaliplatin in the DHAP regimen, another commonly used one in relapsed or refractory NHL, showed meaningful antitumor activity with favourable toxicity profile.
In the previous phase II study of oxaliplatin for treatment of patients with mucosa-associated lymphoid tissue lymphoma, a total of 16 patients with MALT lymphoma of various sites of origin (four of the ocular adnexa, five of the salivary glands, three of the stomach, two of the lung, and one of the colon and the breast) were administered oxaliplatin at a dose of 130 mg/m2 infused during 2 hours every 3 weeks. Fifteen patients responded to chemotherapy, with nine achieving CR (56%), six (37.5%) achieving partial response, and one achieving stable disease; the median time to response was 4 months (range; 2 to 4 months).
Based upon the promising results of oxaliplatin regimen in refractory NHL and first-line treatment of MZL, The investigators are willing to investigate the efficacy and safety of oxaliplatin and prednisolone (Ox-P) combination in patients with previously treated MZL who have a few clinical trial data.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OXP | Experimental | Drug: Oxaliplatin, PrednisoloneOxaliplatin 130mg/m2 + 5DW 500ml MIV over 2HR D1 Prednisolone 100mg/Day D1-D5 Every 3 weeks Maximum 6 cycles of treatment will be given for this study. Subjects will be treated for at least 1 cycle and to a maximum of 6 cycles unless there is documented disease progression, unacceptable adverse events or withdrawal of consent. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Histologically confirmed marginal zone B-cell lymphomas
- Failure to achieve a clinical benefit (≥SD) with the initial treatment, or recurrent disease
- Performance status (ECOG) ≤2
- Age ≥ 20
- At least one or more bi-dimensionally measurable lesion(s) defined as; ≥2 cm by conventional CT or ≥ 1 cm by spiral CT or skin lesion (photographs should be taken) or measurable lesion by physical examination
Key exclusion criteria (5 listed)
- Any other malignancies within the past 5 years except skin basal cell ca or CIS of cervix
- Serious co-morbid diseases
- Pregnancy or breast feeding
- Previous history of drug allergy to one of the drugs in the study regimen
- During this study duration, patients who take other clinical trial medication, chemotherapy, hormonal therapy, or immunotherapy
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 |
|---|---|---|
| Oxaliplatin, PrednisoloneOXALIPLATIN+PREDNISOLONE (OX-P) D1 Oxaliplatin 130mg/m2 + 5DW 500ml MIV over 2hr D1-5 Prednisolone 40-30-30 mg/day P.O every 3 weeks | Drug | OXP |
Primary outcome
Response rate by International Working Group Response Criteria
Time frame: 6 month after treatment
2 secondary outcomes
progression free survival
Time frame: 3 year after start
overall survival
Time frame: 5 year after start
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 4 Nov 2014.
- Derived from this study: PubMed 26413982Oh SY, Kim WS, Kim JS, Chae YS, Lee GW, Eom HS, Ryoo HM, Lee S, Kim SJ, Yoon DH, Won JH, Hong J, Park J, Lee SM, Hong JY, Park E, Kim HJ, Yang DH, Kim HJ, Suh C. A phase II study of oxaliplatin and prednisone for patients with relapsed or refractory marginal zone lymphoma: Consortium for Improving Survival of Lymphoma trial. Leuk Lymphoma. 2016;57(6):1406-12. doi: 10.3109/10428194.2015.1099650. Epub 2015 Nov 16.
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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.
Cheolwon Suh, M.D., Ph.D. principal investigator
Asan Medical Center
Sung Yong Oh, M.D., Ph.D. study director
Dong-A University
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 Oxaliplatin, Prednisolone in people with B-cell Lymphomas, run by Dong-A University Hospital 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 11 inclusion and 5 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 4 Nov 2014. 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 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?
Response rate by International Working Group Response Criteria (time frame: 6 month after treatment). 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 NCT01068392, 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 4 Nov 2014.