Clinical Trials /

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

NCT03578198

Description:

Phase II study of rituximab plus MG4101 in patients with relapsed or refractory indolent CD20-positive non-Hodgkin lymphoma (NHL) Investigator-Initiated Trials

Related Conditions:
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Small Lymphocytic Leukemia
  • Waldenstrom Macroglobulinemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

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

Clinical Trial IDs

  • ORG STUDY ID: Truximab+MG4101
  • NCT ID: NCT03578198

Conditions

  • CD20-positive Non-Hodgkin Lymphoma

Interventions

DrugSynonymsArms
Rituximab + MG4101Rituximab + MG4101

Purpose

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.
    

Trial Arms

NameTypeDescriptionInterventions
Rituximab + MG4101ExperimentalDrug: 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)
  • Rituximab + MG4101

Eligibility Criteria

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:19 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall response rate
Time Frame:Through treatment completion, an average of 25 weeks
Safety Issue:
Description:Investigator-assessed, confirmed objective response by revised response criteria

Secondary Outcome Measures

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

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:Seoul National University Hospital

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