Feasibility Trial of Glofitamab in a Response Adapted Approach Incorporating Interim FDG PET and ctDNA to Optimize Primary Therapy of DLBCL

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a phase ll study of participants with untreated diffuse large B Cell lymphoma (DLBCL).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
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• Men and women ≥ 18 years of age deemed eligible for treatment with full-dose Pola- R-CHP and possible treatment with glofitamab by the qualified investigator.

• Histologic diagnosis of DLBCL and variants according to the WHO 201613 or WHO 202254 classification including DLBCL non-organ-specific (NOS), Germinal centre B-cell type, activated B-cell type, T-cell/histiocyte-rich large B-cell lymphoma, Epstein-Barr Virus (EBV) + DLBCL, Primary mediastinal/thymic large B-cell lymphoma, High grade B-cell lymphoma with myelocytomatosis oncogene (MYC) and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements, High grade B cell lymphoma NOS including lymphomas transformed from previously untreated indolent lymphomas.

• Previously untreated DLBCL with the following exceptions: (a) prior radiotherapy for palliation (not localized), (b) up to 7 days of corticosteroids (prednisone 100mg/day equivalent).

• Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.

• Presence of at least one radiologically measurable nodal or extranodal mass. A measurable nodal mass must have a longest diameter ≥1.5 cm. A measurable extranodal mass should have a longest diameter ≥1.0 cm.16

• Left ventricular ejection fraction (LVEF) ≥ 50%, as determined on cardiac multiple- gated acquisition (MUGA) scan or cardiac echocardiogram (ECHO)

• Women of childbearing potential (WOCBP) who are sexually active must use highly effective methods of contraception during treatment and up to 18 months after the last dose of or protocol therapy. Men who are sexually active must use highly effective methods of contraception during treatment and up to 6 months after the last dose of protocol therapy. Men require an agreement to remain abstinent (ie, refrain from heterosexual intercourse) or use a condom, and an agreement to refrain from donating sperm. Periodic abstinence and withdrawal are not acceptable methods of contraception. Fertility preservation options should be discussed. Examples of highly effective contraceptive methods include an agreement to remain abstinent (ie, refrain from heterosexual intercourse), bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices.

• Willing and able to participate in all required evaluations and procedures in this study.

• Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained by the patient or legally acceptable representative before any study-specific procedures are performed.

Locations
Other Locations
Canada
Princess Margaret Cancer Centre
NOT_YET_RECRUITING
Toronto
Princess Margaret Cancer Centre
RECRUITING
Toronto
Contact Information
Primary
John Kuruvilla, FRCPC
LymphomaClinicalTrials@uhn.ca
4169462821
Time Frame
Start Date: 2025-01-24
Estimated Completion Date: 2027-11
Participants
Target number of participants: 40
Treatments
No_intervention: Pola-R-CHP
Protocol induction: Cycle 1-2~Low-risk group: Cycle 3-4 polatuzumab vedotin 1.8 mg/kg, cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 on day 1, prednisone 100 mg daily days 1-5, and rituximab 375 mg/m2 within 72 hours of polatuzumab vedotin~Cycle 5-6 rituximab 375 mg/m2 on day 1 of cycle 5 and cycle 6
Experimental: Pola-R-CHP and glofitamab
High-risk group: Cycle 3-6 polatuzumab vedotin 1.8 mg/kg, cyclophosphamide 750 mg/m2 and doxorubicin 50 mg/m2 on day 1, prednisone 100 mg daily days 1-5, rituximab 375 mg/m2 within 72 hours of polatuzumab vedotin and Glofitamab 2.5 mg Cycle 3 Day 8 and 10 mg on Day 15 Cycles 3-6
Sponsors
Leads: University Health Network, Toronto

This content was sourced from clinicaltrials.gov