CD20 Positive Diffuse Large B-cell Lymphoma Clinical Trial
— FIL_GAELOfficial title:
GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma A Phase II Study of the Fondazione Italiana Linfomi (FIL)
| Verified date | August 2020 |
| Source | Fondazione Italiana Linfomi ONLUS |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin's lymphoma.
| Status | Terminated |
| Enrollment | 34 |
| Est. completion date | March 22, 2017 |
| Est. primary completion date | March 22, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility | Inclusion Criteria: 1. Histologically proven CD20 positive Diffuse Large B-cell Lymphoma and Follicular grade III B lymphoma, according to WHO (World Health Organization) classification (local pathologist) 2. Age = 65 years 3. No previous treatment 4. CGA assessment (Comprehensive Geriatric Assessment) performed before starting treatment 5. Unfit patients defined as follows: Age > 80 years with Fit profile, i.e. ADL (Activity of Daily Living) =6 residual functions IADL (Instrumental Activity of Daily Living) =8 residual functions CIRS (Cumulative Illness Rating Scale): no comorbidity of grade 3-4 and <5 of grade 2 or Age < 80 with Unfit profile, i.e ADL(Activity of Daily Living) > 5 residual functions IADL (Instrumental Activity of Daily Living) > 6 residual functions CIRS (Cumulative Illness Rating Scale): no comorbidity of grade 3-4 and 5-8 co-morbidities of grade 2 6. Ann Arbor Stage I with bulky, II-IV 7. At least one bi-dimensionally measurable lesion defined as > 1.5 cm in its largest dimension on CT scan 8. ECOG (Eastern Cooperative Oncology Group) performance status of 0, 1, or 2 9. Adequate hematologic function (unless caused by bone marrow infiltrate), defined as follows: Hemoglobin = 10 g/dL Absolute neutrophil count = 1.5 x 109/L Platelet count = 100 x 109/L 10. LVEF (Left Ventricular Ejection Fraction) >50% 11. Ability and willingness to comply with the study protocol procedure 12. Life expectancy > 6 months 13. Accessibility of patient for treatment and follow up 14. Written informed consent Exclusion Criteria: 1. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products 2. Contraindication to any of the individual components of CHOP (Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), including prior receipt of anthracyclines 3. 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 4. Stage I without bulky 5. Patients with transformed lymphoma 6. Prior therapy for DLBCL (Diffuse Large B Cell Lymphoma), with the exception of nodal biopsy or local irradiation 7. Previous exposure to cytotoxic agents 8. Suspect or clinical evidence of CNS (Central Nervous System) involvement by lymphoma 9. HBsAg (Hepatitis B surface antigen), HCV (Hepatitis C Virus) or HIV (Human Immunodeficiency Virus) positivity; isolated HBcAb (Hepatitis B surface antibody) positivity is accepted only with concomitant treatment with Lamivudine 10. AST /ALT (Aspartate Aminotransferase/Alanine Aminotransferase)> twice upper the normal range; bilirubin > twice upper the normal range; serum creatinine > 2.5 mg /dl (unless these abnormalities were related to the lymphoma) 11. Evidence of any severe active acute or chronic infection 12. Concurrent co-morbid medical condition which might exclude administration of full dose chemotherapy |
| Country | Name | City | State |
|---|---|---|---|
| Italy | A.O. SS. Antonio e Biagio e C. Arrigo | Alessandria | |
| Italy | A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona | Ancona | |
| Italy | A.O. Ospedale Degli Infermi | Biella | |
| Italy | A.O. Spedali Civili | Brescia | BS |
| Italy | Area Vasta Romagna e IRST | Meldola (FC) | |
| Italy | IRCCS, Istituto Nazionale dei Tumori | Milano | |
| Italy | A.O. Universitaria Policlinico Di Modena | Modena | |
| Italy | SCDU Ematologia - Università del Piemonte Orientale | Novara | |
| Italy | Irccs Istituto Oncologico Veneto (Iov) | Padova | |
| Italy | Oncoematologia e TMO Dopartimento Oncologia La Maddalena | Palermo | |
| Italy | AUSL di Ravenna | Ravenna | RA |
| Italy | Asmn-Irccs | Reggio Emilia | RE |
| Italy | Ausl Di Rimini | Rimini | |
| Italy | A.O. S. Maria di Terni | Terni | TR |
| Italy | Ematologia 1U - AO Città della Salute e della Scienza | Torino | TO |
| Italy | Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI | Varese |
| Lead Sponsor | Collaborator |
|---|---|
| Fondazione Italiana Linfomi ONLUS |
Italy,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images. | Complete Response Rate after 10 infusions of GA101 and 6 cycles of miniCHOP. Complete Remission (CR): Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, normalization of biochemistry abnormalities. If the bone marrow was involved by lymphoma before treatment, the infiltrate must be cleared on repeat bone marrow aspirate and biopsy of the same site. Partial disease (PR): >= 50% decrease in node diameter of the six largest dominant nodes or nodal masses and no new sites of disease; Stable disease (SD): is defined as less than a PR but is not progressive disease. Progession disease (PD): >50% increase diameter of node from nadir of any previously identified abnormal node nonresponders, and/or appearance of any new lesion. | Up to 36 months. | |
| Secondary | Adverse Events (AEs) | Rate of Adverse Events. Although was not defined a formal threshold, in this section we reported the summary of frequencies of maximum CTCAE observed in patients. Each patient was counted only once within the AE terms during the therapy. If, during the therapy the patient experiences more than one AE, only the AE with the greatest intensity was included in the summary. | Up to 36 months | |
| Secondary | Partial Response Rate (PRR) | Partial Response Rate (PRR): patients in Partial Response after induction therapy.
Frequency of PRR already reported in the table of principal end-point. |
Up to 36 months | |
| Secondary | ORR (Overall Response Rate) | ORR (Overall Response Rate): sum of patiens with Complete or Partial response after the induction therapy. | Up to 36 months | |
| Secondary | OS (Overall Survival) | OS (Overall Survival): defined as the time from the date of treatment start into the study until the date of death irrespective of cause. Patients who have not died at the time of end of the whole study, and patients who are lost to follow up, will be censored at the date of the last contact. | Up to 36 months | |
| Secondary | PFS (Progression Free Survival) | PFS (Progression Free Survival): defined as the time from entry into the study until lymphoma relapse/ progression or death as a result of any cause. Responding patients, patients who are lost to follow up, who withdrawal the consent or drop-out due to adverse event will be censored at their last assessment date. Patients died due to tumor will be considered in progression. Patients died for any other cause will be censored to the death date. | Up to 36 months | |
| Secondary | Activities of Daily Living (ADL) | Change in Activities of daily living score. The score ranging from 0 (bad performance) to 6 (good performance) | Up to 36 months | |
| Secondary | Instrumental Activities of Daily Living (IADL) | Change in Instrumental Activities of Daily Living score. The score ranging from 0 (bad performance) to 8 (good performance). | Up to 36 months | |
| Secondary | Cumulative Illness Rating Scale (CIRS) | Change in Cumulative Illness Rating Scale. The grading of comorbidity ranging from 0 (absent) to 4 (severe). | Up to 36 months | |
| Secondary | Questionnaire for Quality of Life (EORTC QLQ C30) | Change in quality of life (QoL) | Up to 36 months |