Relapsed or Refractory Follicular Lymphoma or Mantle Cell LymphomaPhase 2NCT01678417
131I-rituximab for Relapsed or Refractory Follicular or Mantle Cell Lymphoma
A Phase 2 study testing 131I-rituximab in people with Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma, run by Korea Cancer Center Hospital at 1 site in South Korea.
Trial summary
Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has relatively good prognosis, continual treatment is needed due to frequent relapse. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma
- What is being tested?
- 131I-rituximab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jun 2012to Jun 2017
- 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 follicular lymphoma or mantle cell lymphoma
- relapsed or refractory patients
- Eastern Cooperative Oncology Group performance status ≤ 2
- age≥ 20 years
- More than one measurable lesion (More than 2cm sized lesion in conventional CT scan,More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT)
- Adequate renal function (serum creatinine ≤ 2.0 mg/dl or Ccr ≥ 60 ml/min)
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- Adequate hepatic function (serum bilirubin ≤ 2.0 mg/dl , AST/ALT ≤ 3 upper normal limit)
- Adequate bone marrow reservoir (ANC ≥1,500/㎕, platelet count≥ 75,000/㎕)
- patient who agree the purpose and intention of this clinical trial
Who cannot join
- recent (<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)
- hemodynamically unstable due to the recent (<12 months) history of severe
- heart disease such as myocardial infarction
- acute complications of severe lung or metabolic disease
- Combined severe neurological or psychiatric disease
- Unrecovered from infection or other medical disease
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- Recent (<30 days) history of enrollment of other clinical trial
- Pregnant or breast-feeding woman
- women of childbearing potential and men not employing adequate contraception at least for 1 year
- previous history drug allergy to the content of 131I-rituximab
- Infection(sepsis, pneumonia, viral infection, etc) (inactivated hepatitis B carrier can be enrolled)
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
Seoul, 139-706
Hye Jin Kang, M.D.
Dong-Yeop Shin, M.D.
About this study
Official title: A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma
Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has relatively good prognosis, continual treatment is needed due to frequent relapse. FL with histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma. Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with FL or MCL
- Being tested
- 131I-rituximab
- Medical subject headings
- Recurrence, Lymphoma, Follicular, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
131I-rituximabDrug
| Study group | Role | What they receive |
|---|---|---|
| 131I-rituximab | Experimental | 131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles Receives: Drug: 131I-rituximab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Measured: up to 5 years
Secondary outcomes (4)
Response duration
Measured: up to 5 years
Overall survival
Measured: up to 5 years
Number of Adverse Events
Measured: up to 5 years
progression free survival
Measured: up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Follicular Lymphoma or Mantle 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
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea Cancer Center Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Hye Jin Kang, M.D., Principal investigator, Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01678417
- Sponsor's protocol ID
- FL or MCL 131I-rituximab RIT
- Status last verified
- Aug 2012
- First submitted
- 30 Aug 2012
- Last updated
- 5 Sep 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Study of 131I-rituximab for Patients With Relapsed or Refractory Follicular or Mantle Cell Lymphoma
- ClinicalTrials.gov ID
- NCT01678417
- Acronym / sponsor ID
- FL or MCL 131I-rituximab RIT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Korea Cancer Center HospitalUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 5 Sep 2012 (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.
Follicular lymphoma (FL) and mantle cell lymphoma (MCL) are rare lymphomas which consist of less than 5% of non-Hodgkin lymphoma in Korea. Although FL with histologic grade 1 or 2 has relatively good prognosis, continual treatment is needed due to frequent relapse. FL with histologic grade 3 has poor prognosis similar to that of diffuse large B cell lymphoma. Meanwhile, the response rate to systemic chemotherapy in MCL is low, so the treatment of relapsed MCL is challenging. So we investigate the efficacy of radioimmunotherapy using 131I-rituximab in refractory or relapsed patients with FL or MCL
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 131I-rituximab | Experimental | Drug: 131I-rituximab131I-rituximab treatment interval at least 4 weeks up to maximum 6 cycles |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histologically confirmed follicular lymphoma or mantle cell lymphoma
- relapsed or refractory patients
- Eastern Cooperative Oncology Group performance status ≤ 2
- age≥ 20 years
- More than one measurable lesion (More than 2cm sized lesion in conventional CT scan,More than 1cm sized lesion in spiral CT or contrast-enhanced PET/CT)
Key exclusion criteria (11 listed)
- recent (<5 years) history of other malignancy or unrecovered from the disease (appropriately treated skin cancer and uterine cervix carcinoma in situ are excluded)
- hemodynamically unstable due to the recent (<12 months) history of severe
- heart disease such as myocardial infarction
- acute complications of severe lung or metabolic disease
- Combined severe neurological or psychiatric disease
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 |
|---|---|---|
| 131I-rituximab | Drug | 131I-rituximab |
Primary outcome
Overall response rate
Time frame: up to 5 years
4 secondary outcomes
Response duration
Time frame: up to 5 years
Overall survival
Time frame: up to 5 years
Number of Adverse Events
Time frame: up to 5 years
progression free survival
Time frame: up to 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2012.
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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.
Hye Jin Kang, M.D. principal investigator
Korea Cancer Center Hospital, Korea Institute of Radiological and Medical Sciences
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 131I-rituximab in people with Relapsed or Refractory Follicular Lymphoma or Mantle Cell Lymphoma, run by Korea Cancer Center 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 9 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 5 Sep 2012. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hye Jin Kang, M.D. (+82-2-970-1289, mdhyejin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall response rate (time frame: up to 5 years). 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 5 Sep 2012.