A Study of Ibrutinib With Rituximab in People With Untreated Marginal Zone Lymphoma

Part of paid clinical trials in Washington D.C., District of Columbia.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT04212013
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Marginal Zone Lymphoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ibrutinib — DRUG
    Ibrutinib capsules (140 mg each) will be dosed at 560 mg once daily on a 28-day cycle on a continuous basis.
  • Rituximab — DRUG
    Will receive rituximab: 375 mg/m\^2 on days 1, 8, 15 and 22 of cycle 1
  • Placebo — OTHER
    Placebo capsules will be similarly dosed at 4 capsules daily.

Study Details

The purpose of this study is to see if the combination of rituximab and ibrutinib can help people with marginal zone lymphoma who have not received treatment in the past. The study will also compare the combination of rituximab and ibrutinib with the combination of rituximab and placebo to see which combination works better.

Key Dates

Start date
Dec 23, 2019
Status verified
Jul 2025
Primary completion
Mar 18, 2027
Completion
Mar 18, 2027

Study Design

Enrollment
23 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ibrutinib/Rituximab
    All subjects meeting eligibility criteria will receive rituximab: 375 mg/m\^2 on days 1, 8, 15 and 22 on cycle 1.
  • Placebo Comparator: Ibrutinib/Placebo
    Ibrutinib capsules (140 mg each) will be dosed at 560 mg once daily on a 28-day cycle on a continuous basis. Placebo capsules will be similarly dosed at 4 capsules daily.

Primary Outcome Measure

complete response [ Time Frame: 30 months after randomization ]

Locations (10)

FacilityCityStateZIPSite coordinators
George Washington Cancer CenterWashington D.C.District of Columbia20037-
Moffitt Cancer CenterTampaFlorida33612-
Mayo Clinic Cancer CenterRochesterMinnesota55905-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering NassauUniondaleNew York11553-

Find similar trials in Washington D.C., DC

By research site
George Washington Cancer Center· Washington D.C., DCMoffitt Cancer Center· Tampa, FLMayo Clinic Cancer Center· Rochester, MNMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJ

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