Rituximab Plus MG4101 Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)

CD20-positive Non-Hodgkin Lymphoma Clinical Trial

— MG4101  

Official title:

Phase II Study of Rituximab Plus MG4101 in Patients With Relapsed or Refractory Indolent CD20-positive Non-Hodgkin Lymphoma (NHL)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03578198
• Other study ID #: Truximab+MG4101
• Status: Terminated
• Phase: Phase 2
• Start date: November 8, 2018
• Est. completion date: April 7, 2022

Study information

• Verified date: October 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: April 7, 2022
• Est. primary completion date: April 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Histologically confirmed indolent CD20-positive NHLs (iNHLs; follicular lymphoma grade 1-3a, marginal zone B-cell lymphoma, small lymphocytic lymphoma, Waldenstrom macroglobulinemia)

2. CD20-positive iNHL patients who relapsed or progressed

3. = 19 years

4. ECOG PS 0-2

5. At least one bidimensionally measurable disease (or presence of IgM paraproteinemia = 2 x ULN for Waldenstrom macroglobulinemia)

6. Adequate hematologic, renal, and hepatic functions

7. Appropriate methods of contraception during the study

8. Written informed consent

Exclusion Criteria:

1. Not all of the above inclusion criteria are met.

2. Prior chemotherapy within 4 weeks or radiotherapy within 6 weeks

3. Corticosteroids > 10mg/day during last 28 days

4. Evidence of CNS involvement by lymphomas

5. Active HBV/HCV infections, known HIV infection

6. Prior diagnosis of cancers within 5 years

7. Serious concurrent cardiovascular disease

8. Patients who are pregnant or lactating

Related Conditions & MeSH terms

• CD20-positive Non-Hodgkin Lymphoma
• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

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)

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
Seoul National University Hospital	Gyeongsang National University Hospital, Hallym University Medical Center, Kyunghee University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	Investigator-assessed, confirmed objective response by revised response criteria	Through treatment completion, an average of 25 weeks
Secondary	Complete remission rate	Confirmed complete remission by revised response criteria	Through treatment completion, an average of 25 weeks
Secondary	Progression-free survival	PFS as defined by revised response criteria	From date of initiation until the date of first documented progression, whichever came first, assessed up to 2 years
Secondary	Overall survival	OS as defined by revised response criteria	Through study completion, an average of 2 years