Phase 2 Trial of Obinutuzumab and CC-99282 for Patients With Previously Untreated High Tumor Burden Follicular Lymphoma

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06108232
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Obinutuzumab — DRUG
    Given by IV (vein)
  • CC-99282 — DRUG
    Given by PO

Study Details

To learn if obinutuzumab in combination with CC-99282 can help to control previously untreated, high tumor burden FL

Key Dates

First listed
Oct 30, 2023
Start date
Mar 15, 2024
Status verified
Aug 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
83 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Obinutuzumab+CC-99282
    Participants will receive obinutuzumab and CC-99282 together for up to 12 study cycles. Each study cycle is 28 days. Participants will first receive the study drugs for Cycles 1-6. Then after participants complete Cycle 6, the study doctor will decide based on the status of the disease if participant will continue to receive the study drugs for Cycles 7-12 or if participant will stop receiving them.

Primary Outcome Measure

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Dai Chihara, M D, PhD
[email protected]
713-792-2860
Dai Chihara, M D, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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