Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-005697-10 | EudraCT Number |
Not provided
Not provided
Primary objective not obtained after interim analysis
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
GA101-miniCHOP regimen for the treatment of elderly unfit patients with diffuse large B-cell non-Hodgkin's lymphoma.
Considering that the treatment of elderly unfit patients with DLBCL cannot be based on a full course of R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone), and that using a less intense R-miniCHOP (an attenuated version of the standard R-CHOP: Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone) combination an acceptable cure rate can be achieved this study is designed to try to improve the cure rate in unfit patients with DLBCL (Diffuse Large B Cell Lymphoma) by adopting the R-miniCHOP scheme substituting Rituximab with the more active GA101 monoclonal antibody. The study hypothesis is that a higher activity of the treatment can be achieved without modifying the cytotoxic part of the treatment but using a more active immunotherapy. Differently from the previous experience with R-miniCHOP eligible patient are not only identified using anagraphic criteria but adopting CGA (Comprehensive Geriatric Assessment) as part of initial assessment and considering as eligible unfit patients.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ga101-miniCHOP | Experimental | 6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101). GA101-miniCHOP regimen:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ga101 | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
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:
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
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
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
LVEF (Left Ventricular Ejection Fraction) >50%
Ability and willingness to comply with the study protocol procedure
Life expectancy > 6 months
Accessibility of patient for treatment and follow up
Written informed consent
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Francesco Merli, MD | Ematologia - IRCCS Arcispedale Santa Maria Nuova | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| A.O. Spedali Civili | Brescia | BS | 25100 | Italy | ||
| AUSL di Ravenna |
One case excluded for violation of inclusion criteria (transformed lymphoma)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Single Arm | 6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101) miniCHOP: an attenuated version of the standard CHOP, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 29, 2014 | Aug 19, 2020 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| ORR (Overall Response Rate) | ORR (Overall Response Rate): sum of patiens with Complete or Partial response after the induction therapy. | Up to 36 months |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Questionnaire for Quality of Life (EORTC QLQ C30) | Change in quality of life (QoL) | Up to 36 months |
| Ravenna |
| RA |
| 48100 |
| Italy |
| Asmn-Irccs | Reggio Emilia | RE | 43123 | Italy |
| Ematologia 1U - AO Città della Salute e della Scienza | Torino | TO | 10126 | Italy |
| A.O. S. Maria di Terni | Terni | TR | 05100 | Italy |
| A.O. SS. Antonio e Biagio e C. Arrigo | Alessandria | 15121 | Italy |
| A.O. Universitaria Ospedali Riuniti - Ospedale Umberto I Di Ancona | Ancona | 60126 | Italy |
| A.O. Ospedale Degli Infermi | Biella | 13900 | Italy |
| Area Vasta Romagna e IRST | Meldola (FC) | Italy |
| IRCCS, Istituto Nazionale dei Tumori | Milan | Italy |
| A.O. Universitaria Policlinico Di Modena | Modena | 41124 | Italy |
| SCDU Ematologia - Università del Piemonte Orientale | Novara | 28100 | Italy |
| Irccs Istituto Oncologico Veneto (Iov) | Padova | 35128 | Italy |
| Oncoematologia e TMO Dopartimento Oncologia La Maddalena | Palermo | Italy |
| Ausl Di Rimini | Rimini | 47924 | Italy |
| Ematologia - OSPEDALE DI CIRCOLO E FONDAZIONE MACCHI | Varese | 21100 | Italy |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | 6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||||
| Hemoglobin | Median | Inter-Quartile Range | g/dL |
| |||||||||||||||||||
| Stage | Ann Arbor Staging: Stage I: nvolvement of a single lymph node region or lymphoid structure. Stage II: Involvement of two or more lymph node regions on the same side of the diaphragm. Stage III: Involvement of lymph regions or structures on both sides of the diaphragm. Stage IV: Involvement of extranodal site(s) beyond that designated as an involvement of a single, extranodal site contiguous or proximal to known nodal site. Bone marrow or liver involvement will always be considered as stage IV. | Count of Participants | Participants |
| |||||||||||||||||||
| Bone Marrow Involvement | Count of Participants | Participants |
| ||||||||||||||||||||
| Symptoms | The presence of (a) unexplained weight loss of more than 10% of the body weight during the 6 months before initial staging investigation and/or (b) unexplained, persistent, or recurrent fever with temperatures above 38 C during the previous month and/or (c) recurrent drenching night sweats during the previous months is denoted by the suffix letter 'B'. 'A' indicates the absence of these symptoms | Count of Participants | Participants |
| |||||||||||||||||||
| ECOG PS (Eastern Cooperative Oncology Group Performance Status) | ECOG Performance Status grade: 0 Able to carry out all normal activity without restriction
| Count of Participants | Participants |
| |||||||||||||||||||
| LDH (lactate dehydrogenase) | Ratio between measured level of LDH with the upper limit of normality. LDH levles with ratio <=1 was considered normal, LDH levels with ratio >1 was considered elevated. | Count of Participants | Participants |
| |||||||||||||||||||
| International Prognostic Index | International Prognostic Index (IPI): ranging fron 0 to 5. In this study was grouped 0-1 Low risk, 2 Intermediate risk, 3/5 High risk. | Count of Participants | Participants |
| |||||||||||||||||||
| Comprehensive Geriatric Assessment | Comprehensive Geriatric Assessment (CGA): FIT patients, without any co-morbidity; UNFIT patients, with mild co-morbidities; FRAIL patients, with severe co-morbidities. | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Patients who received at last 1 cycle of treatment | Posted | Count of Participants | Participants | 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. | Patients who received at least 1 cycle of treatment. | Posted | Count of Participants | Participants | 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. | Posted | Count of Participants | Participants | 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. | Patients who received at leat 1 cycle of treatment | Posted | Count of Participants | Participants | 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. | Posted | Mean | 95% Confidence Interval | Probability at 24 months | 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. | Posted | Mean | 95% Confidence Interval | Probability at 24 months | 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) | Not Posted | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||
| 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). | Not Posted | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Illness Rating Scale (CIRS) | Change in Cumulative Illness Rating Scale. The grading of comorbidity ranging from 0 (absent) to 4 (severe). | Not Posted | Up to 36 months | Participants | |||||||||||||||||||||||||||||||||||
| Secondary | Questionnaire for Quality of Life (EORTC QLQ C30) | Change in quality of life (QoL) | Not Posted | Up to 36 months | Participants |
50 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Single Arm | 6 courses of GA101-miniCHOP regimen and 2 additional infusions of GA101, every 21 days (for a total of 6 courses of miniCHOP and 10 infusions of GA101). NOTE: One SAE (atrial fibrillation) was recorded in patient excluded from analysis (not eligible for transformed lymphoma), exit before starting the 1st cycle of treatment. | 11 | 33 | 6 | 33 | 30 | 33 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Femur fracture | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Congestive heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| -sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| BCPO-Heart failure | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Non small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Lumbar pain, vertebral collapse | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anemia | Blood and lymphatic system disorders | MedDRA (10.0) | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Cardiac disorders | Cardiac disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Gastrointestinal disorders | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| General disorders | General disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Hepatobiliary disorders | Hepatobiliary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Infections | Infections and infestations | CTCAE (3.0) | Systematic Assessment |
| |
| Injury | Injury, poisoning and procedural complications | CTCAE (3.0) | Systematic Assessment |
| |
| Investigations | Investigations | CTCAE (3.0) | Systematic Assessment |
| |
| Metabolism | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Musculoskeletal | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | CTCAE (3.0) | Systematic Assessment |
| |
| Nervous system | Nervous system disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Renal | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Respiratory | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Vascular | Vascular disorders | CTCAE (3.0) | Systematic Assessment |
| |
| Other | General disorders | CTCAE (3.0) | Systematic Assessment |
|
The Sponsor, in accordance with art.5 of DM, minist. decree (Feb8,2013), guarantees the publication of the results of the study without any constraints and ensuring all the participating centres a proportional visibility to the actual participation. The single centre will be able to publish partial data of patients treated at the centre after the publication of the global results, or 24 months after the last patient's enrolment date, regardless of which centre the last patient was recruited at.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Luigi Marcheselli - FIL statistician | Fondazione Italiana Linfomi ONLUS | 059 4223873 | lmarcheselli@filinf.it |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2020 | Aug 19, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| C543332 | obinutuzumab |
Not provided
Not provided
Not provided
| Unknown or Not Reported |
|
| IV |
|
| 2-3 |
|
| 3/5 |
|
| Progression Disease |
|
| Not Assessed |
|
|
| Title | Denominators | Categories | ||||||
|---|---|---|---|---|---|---|---|---|
|
| Title | Denominators | Categories | ||||||
|---|---|---|---|---|---|---|---|---|
|
|
|