Maintenance Obinutuzumab in Treating Patients With Central Nervous System Lymphoma Who Have Achieved a Complete or Partial Response

Part of paid clinical trials in New York, New York.

Sponsor
Providence Health & Services
Study ID
NCT06175000
Phase
PHASE2
Status
Recruiting
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Conditions

  • Primary Central Nervous System Lymphoma

Eligibility Criteria

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

Interventions

  • Cognitive Assessment — PROCEDURE
    Ancillary studies to evaluate neurocognitive function at study entry and at 2 years after study entry.
  • Obinutuzumab — BIOLOGICAL
    Given IV
  • Quality of Life Assessment — OTHER
    Ancillary studies to evaluate quality of life at study entry and at 2 years after study entry.

Study Details

This randomized phase II trial studies how well obinutuzumab works as maintenance treatment in patients with central nervous system lymphoma who have achieved the disappearance of all signs of cancer in response to treatment (complete response) or a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment (partial response). Immunotherapy with obinutuzumab, may induce changes in body's immune system and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Mar 13, 2024
Status verified
Jun 2025
Primary completion
Sep 15, 2028
Completion
Sep 15, 2029

Study Design

Enrollment
28 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm I (obinutuzumab
    Patients receive obinutuzumab IV on days 1 and 2 for the first cycle, and on day 1 for the subsequent cycles, and on day 1 for the subsequent cycles. Cycles repeat every 60 days for 2 years in the absence of disease progression or unacceptable toxicity.
  • Active Comparator: Arm II (observation)
    Patients undergo observation for a total of 2 years.

Primary Outcome Measure

Partial response (PR) or complete response (CR) duration [ Time Frame: From the date of brain magnetic resonance imaging (MRI) after completion of first-line treatment which confirms PR or CR, to disease progression or death, assessed up to 2 years ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Lindey Myers
[email protected]
917-453-2968
Christian Grommes, MD (PRINCIPAL_INVESTIGATOR)
Cleveland ClinicClevelandOhio44195
David Peereboom, MD
[email protected]
216-445-6068
David Peereboom, MD (PRINCIPAL_INVESTIGATOR)
Providence Health & Services; Providence Neurological SpecialtiesPortlandOregon97225
Kai Darke
[email protected]
503-216-0627
Tigest Mequanint
[email protected]
503-216-0875
Prakash Ambady, MD (PRINCIPAL_INVESTIGATOR)
Pennsylvania State UniversityHersheyPennsylvania17033
Micaiah Grien
[email protected]
717-531-0003
Sara Craig
[email protected]
717-531-0003
Dawit Aregawi, MD (PRINCIPAL_INVESTIGATOR)
University of VermontBurlingtonVermont05405
Isza Parchini
[email protected]
802-656-9447
George Davis
[email protected]
Alissa Thomas, MD (PRINCIPAL_INVESTIGATOR)
University of VirginiaCharlottesvilleVirginia22903
Nija Desai
[email protected]
434-982-6455
Patrick Heffernan
[email protected]
434-243-9508
David Schiff, MD (PRINCIPAL_INVESTIGATOR)
Ivy Center for Advanced Brain Tumor Treatment; Swedish Neuroscience InstituteSeattleWashington98122
Gary Brown
[email protected]
206-320-2608
Nathan Hansen
[email protected]
206-320-3542
Alipi Bomn, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
Memorial Sloan Kettering Cancer Center· New York, NYCleveland Clinic· Cleveland, OHProvidence Health & Services; Providence Neurological Specialties· Portland, ORPennsylvania State University· Hershey, PAUniversity of Vermont· Burlington, VTUniversity of Virginia· Charlottesville, VA

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