A Study of Glofitamab-based Treatment in People With Diffuse Large B-cell Lymphoma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06765317
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Diffuse Large B Cell Lymphoma (DLBCL)
  • High Grade B Cell Lymphoma

Eligibility Criteria

Sex
ALL
Age
65 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Glofitamab — DRUG
    C1D8 2.5 mg iv; C1D15 10 mg iv; C2D1-onwards: 30 mg iv, every 3 weeks
  • Polatuzumab — DRUG
    1.8 mg/kg iv C1D1 onwards, every 3 weeks
  • Rituximab — DRUG
    375 mg/m2 iv D1
  • Cyclophosphamide — DRUG
    400 mg/m2 iv D1
  • Doxorubicin — DRUG
    25 mg/m2 iv D1
  • Obinutuzumab: — DRUG
    1000 mg iv C1D1 (7 days prior to glofitamab administration) single dose

Study Details

The researchers are doing this study to find out if the study treatment is an effective treatment that causes few or mild side effects in people with diffuse large B-cell lymphoma (DLBCL), high-grade B-cell lymphoma (HGBCL), or transformed lymphoma. The treatment being tested in this study is glofitamab, polatuzumab, and obinutuzumab in combination with standard treatment (the combination of rituximab, cyclophosphamide, doxorubicin, and prednisone, or R-miniCHP).

Key Dates

Start date
Jan 16, 2025
Status verified
Jun 2026
Primary completion
Jan 31, 2028
Completion
Jan 31, 2028

Study Design

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

Arms

  • Experimental: Obinutuzumab, Glofitamab and Polatuzumab
    All patients will receive 2 cycles of glofitamab and polatuzumab followed by an interim PET scan (iPET2). If iPET2 is negative (Deauville score 1-3), patients will receive 4 cycles of glofitamab-polaRminiCHP. If iPET is positive (Deauville score 4,5) with partial response or stable disease, patients will receive 6 cycles of glofitamab-pola-R-miniCHP (polatuzumab will be omitted from last 2 cycles to keep total number of doses at 6 per standard of care)

Primary Outcome Measure

evaluate the complete response rate (CRR) [ Time Frame: 1 year ]

Central Contacts

Locations (8)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Pallawi Torka, MD
201-775-7808
Hackensack Meridian Health (Data collection only)HackensackNew Jersey07601
Andrew Ip, MD
551-996-3033
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Pallawi Torka, MD
201-775-7808
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Pallaw Torka, MD
201-775-7808
Memorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Pallawi Torka, MD
201-775-7808
Memorial Sloan Kettering Westchester (All Protocol Activities)HarrisonNew York10604
Pallawi Torka, MD
201-775-7808
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Pallawi Torka, MD
201-775-7808
Memorial Sloan Kettering Nassau (Limited Protocol Activities)Rockville CentreNew York11553
Pallawi Torka, MD
201-775-7808

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJHackensack Meridian Health (Data collection only)· Hackensack, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (All Protocol Activities)· Harrison, NY

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