GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-… (NCT02495454) | Clinical Trial Compass
TerminatedPhase 2
GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma
Stopped: Primary objective not obtained after interim analysis
Italy34 participantsStarted 2015-08-25
Plain-language summary
GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin's lymphoma.
Who can participate
Age range65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically proven CD20 positive Diffuse Large B-cell Lymphoma and Follicular grade III B lymphoma, according to WHO (World Health Organization) classification (local pathologist)
✓. Age ≥ 65 years
✓. No previous treatment
✓. CGA assessment (Comprehensive Geriatric Assessment) performed before starting treatment
✓. Unfit patients defined as follows:
✓. Ann Arbor Stage I with bulky, II-IV
✓. At least one bi-dimensionally measurable lesion defined as \> 1.5 cm in its largest dimension on CT scan
✓. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2
Exclusion criteria
✕. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
✕. Contraindication to any of the individual components of CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), including prior receipt of anthracyclines
✕. History of other malignancies within 5 years prior to study entry except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer
✕. Stage I without bulky
What they're measuring
1
Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images.