CD20-positive Non-Hodgkin LymphomaPhase 2MG4101NCT03578198
Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
A Phase 2 study testing Rituximab + MG4101 in people with CD20-positive Non-Hodgkin Lymphoma, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- CD20-positive Non-Hodgkin Lymphoma
- What is being tested?
- Rituximab + MG4101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteSouth Korea
- Study dates
- 8 Nov 2018to 7 Apr 2022
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed indolent CD20-positive NHLs (iNHLs; follicular lymphoma grade 1-3a, marginal zone B-cell lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia)
- CD20-positive iNHL patients who relapsed or progressed
- ≥ 19 years
- ECOG PS 0-2
- At least one bidimensionally measurable disease (or presence of IgM paraproteinemia ≥ 2 x ULN for Waldenstrom macroglobulinemia)
- Adequate hematologic, renal, and hepatic functions
- Appropriate methods of contraception during the study
- Written informed consent
Who cannot join
- Not all of the above inclusion criteria are met.
- Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
- Corticosteroids > 10mg/day during last 28 days
- Evidence of CNS involvement by lymphomas
- Active HBV/HCV infections, known HIV infection
- Prior diagnosis of cancers within 5 years
- Serious concurrent cardiovascular disease
- Patients who are pregnant or lactating
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials
Read the detailed description
Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of rituximab plus MG4101 in patients with indolent CD20-positive NHLs who has relapsed or refractory to prior chemotherapy or chemo-radiotherapy.
- Conditions
- CD20-positive Non-Hodgkin Lymphoma
- Being tested
- Rituximab + MG4101
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rituximab + MG4101Drug
- Induction phase:
- Rituximab (Truxima) 375mg/m2 IV Weekly (X4)
- MG4101 3x107 cells/kg IV Weekly (X4)
- Maintenance phase
- Rituximab (Truxima) 375mg/m2 IV q 4 weeks (X4)
- MG4101 3x107 cells/kg IV q 4 weeks (X4)
| Study group | Role | What they receive |
|---|---|---|
| Rituximab + MG4101 | Experimental | Drug: Rituximab + MG4101
Induction phase:
Rituximab (Truxima) 375mg/m2 IV Weekly (X4) MG4101 3x107 cells/kg IV Weekly (X4) Maintenance phase
Rituximab (Truxima) 375mg/m2 IV q 4 weeks (X4) MG4101 3x107 cells/kg IV q 4 weeks (X4) Receives: Drug: Rituximab + MG4101 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall response rate
Investigator-assessed, confirmed objective response by revised response criteria
Measured: Through treatment completion, an average of 25 weeks
Secondary outcomes (3)
Complete remission rate
Confirmed complete remission by revised response criteria
Measured: Through treatment completion, an average of 25 weeks
Progression-free survival
PFS as defined by revised response criteria
Measured: From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 years
Overall survival
OS as defined by revised response criteria
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2018
- Study start8 Nov 2018
- Primary completion7 Apr 2022
- Study completion7 Apr 2022
Why it stopped: Issues in supply of IP
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD20-positive Non-Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by Seoul National 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hallym University Medical Center, Kyunghee University Medical Center, Gyeongsang National University Hospital
- Responsible party
- Principal investigator, Tae Min Kim, Seoul National University Hospital
- Investigators
- Tae Min Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03578198
- Sponsor's protocol ID
- Truximab+MG4101
- Acronym
- MG4101
- Status last verified
- Oct 2022
- First submitted
- 25 Jun 2018
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)
- ClinicalTrials.gov ID
- NCT03578198
- Acronym / sponsor ID
- MG4101 / Truximab+MG4101
- Conditions
- CD20-positive Non-Hodgkin Lymphoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issues in supply of IP
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Hallym University Medical Center, Kyunghee University Medical Center, Gyeongsang National University Hospital
- Study start
- 8 Nov 2018 (actual)
- Primary completion
- 7 Apr 2022 (actual)
- Study completion
- 7 Apr 2022 (actual)
- First posted
- 6 Jul 2018 (actual)
- 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.
Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials
Detailed description
Multi-center trial, Phase II, non-randomized, open-label, single-arm study with combined therapy of rituximab plus MG4101 in patients with indolent CD20-positive NHLs who has relapsed or refractory to prior chemotherapy or chemo-radiotherapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rituximab + MG4101 | Experimental | Drug: Rituximab + MG4101Drug: Rituximab + MG4101 Induction phase: Rituximab (Truxima) 375mg/m2 IV Weekly (X4) MG4101 3x107 cells/kg IV Weekly (X4) Maintenance phase Rituximab (Truxima) 375mg/m2 IV q 4 weeks (X4) MG4101 3x107 cells/kg IV q 4 weeks (X4) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Histologically confirmed indolent CD20-positive NHLs (iNHLs; follicular lymphoma grade 1-3a, marginal zone B-cell lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia)
- CD20-positive iNHL patients who relapsed or progressed
- ≥ 19 years
- ECOG PS 0-2
- At least one bidimensionally measurable disease (or presence of IgM paraproteinemia ≥ 2 x ULN for Waldenstrom macroglobulinemia)
Key exclusion criteria (8 listed)
- Not all of the above inclusion criteria are met.
- Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks
- Corticosteroids > 10mg/day during last 28 days
- Evidence of CNS involvement by lymphomas
- Active HBV/HCV infections, known HIV infection
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 |
|---|---|---|
| Rituximab + MG41011. Induction phase: * Rituximab (Truxima) 375mg/m2 IV Weekly (X4) * MG4101 3x107 cells/kg IV Weekly (X4) 2. Maintenance phase * Rituximab (Truxima) 375mg/m2 IV q 4 weeks (X4) * MG4101 3x107 cells/kg IV q 4 weeks (X4) | Drug | Rituximab + MG4101 |
Primary outcome
Overall response rate
Time frame: Through treatment completion, an average of 25 weeks
Investigator-assessed, confirmed objective response by revised response criteria
3 secondary outcomes
Complete remission rate
Time frame: Through treatment completion, an average of 25 weeks
Progression-free survival
Time frame: From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 years
Overall survival
Time frame: Through study completion, an average of 2 years
Results and safety
The study was stopped early (reason given: Issues in supply of IP). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Tae Min Kim, MD, PhD principal investigator
Seoul National University Hospital
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 + MG4101 in people with CD20-positive Non-Hodgkin Lymphoma, run by Seoul National 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 8 inclusion and 8 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 27 Oct 2022. 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: Issues in supply of IP). 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 response rate (time frame: Through treatment completion, an average of 25 weeks). 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 27 Oct 2022.