Trial Outcomes & Findings for GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma (NCT NCT02495454)

Last Updated: 2020-11-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

34 participants

Primary outcome timeframe

Up to 36 months.

Results posted on

2020-11-05

Participant Flow

One case excluded for violation of inclusion criteria (transformed lymphoma)

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	34
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

GA101-miniCHOP Regimen for the Treatment of Elderly Unfit Patients With Diffuse Large B-cell Non-Hodgkin's Lymphoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm n=33 Participants 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)
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	33 Participants n=5 Participants
Age, Continuous	82 years n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Italy	33 participants n=5 Participants
Hemoglobin	12.9 g/dL n=5 Participants
Stage II	6 Participants n=5 Participants
Stage III	11 Participants n=5 Participants
Stage IV	16 Participants n=5 Participants
Bone Marrow Involvement Negative	27 Participants n=5 Participants
Bone Marrow Involvement Positive	6 Participants n=5 Participants
Symptoms Absence of symptoms	27 Participants n=5 Participants
Symptoms Presence of symptoms	6 Participants n=5 Participants
ECOG PS (Eastern Cooperative Oncology Group Performance Status) 0	12 Participants n=5 Participants
ECOG PS (Eastern Cooperative Oncology Group Performance Status) 1	19 Participants n=5 Participants
ECOG PS (Eastern Cooperative Oncology Group Performance Status) 2-3	2 Participants n=5 Participants
LDH (lactate dehydrogenase) <= Upper Limit	10 Participants n=5 Participants
LDH (lactate dehydrogenase) > Upper Limit	23 Participants n=5 Participants
International Prognostic Index 0-1	4 Participants n=5 Participants
International Prognostic Index 2	8 Participants n=5 Participants
International Prognostic Index 3/5	21 Participants n=5 Participants
Comprehensive Geriatric Assessment UNFIT	28 Participants n=5 Participants
Comprehensive Geriatric Assessment FRAIL	5 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 36 months.

Population: Patients who received at last 1 cycle of treatment

Outcome measures

Outcome measures
Measure	Single Arm n=33 Participants 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)
Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images. Complete Response	14 Participants
Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images. Partial Response	8 Participants
Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images. Stable Disease	2 Participants
Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images. Progression Disease	8 Participants
Complete Response Rate (CRR). Based a Central Independent Review Committee Considering Use the Conventional CT Scan Images. Not Assessed	1 Participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: Patients who received at least 1 cycle of treatment.

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.

Outcome measures

Outcome measures
Measure	Single Arm n=33 Participants 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)
Adverse Events (AEs) CTCAE Grade 0	5 Participants
Adverse Events (AEs) CTCAE grade 1-2	11 Participants
Adverse Events (AEs) CTCAE grade >2	17 Participants

SECONDARY outcome

Timeframe: Up to 36 months

Partial Response Rate (PRR): patients in Partial Response after induction therapy. Frequency of PRR already reported in the table of principal end-point.

Outcome measures

Outcome measures
Measure	Single Arm n=33 Participants 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)
Partial Response Rate (PRR) Partial Remission	8 Participants
Partial Response Rate (PRR) Not in partial remission	25 Participants

SECONDARY outcome

Timeframe: Up to 36 months

Population: Patients who received at leat 1 cycle of treatment

ORR (Overall Response Rate): sum of patiens with Complete or Partial response after the induction therapy.

Outcome measures

Outcome measures
Measure	Single Arm n=33 Participants 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)
ORR (Overall Response Rate) ORR	22 Participants
ORR (Overall Response Rate) Less than ORR	11 Participants

SECONDARY outcome

Timeframe: Up to 36 months

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.

Outcome measures

Outcome measures
Measure	Single Arm n=33 Participants 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)
OS (Overall Survival)	0.69 Probability at 24 months Interval 0.5 to 0.82

SECONDARY outcome

Timeframe: Up to 36 months

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.

Outcome measures

Outcome measures
Measure	Single Arm n=33 Participants 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)
PFS (Progression Free Survival)	0.53 Probability at 24 months Interval 0.34 to 0.68

SECONDARY outcome

Timeframe: Up to 36 months

Change in Activities of daily living score. The score ranging from 0 (bad performance) to 6 (good performance)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 36 months

Change in Instrumental Activities of Daily Living score. The score ranging from 0 (bad performance) to 8 (good performance).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 36 months

Change in Cumulative Illness Rating Scale. The grading of comorbidity ranging from 0 (absent) to 4 (severe).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 36 months

Change in quality of life (QoL)

Outcome measures

Outcome data not reported

Adverse Events

Single Arm

Serious events: 6 serious events

Other events: 30 other events

Deaths: 11 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm n=33 participants at risk 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.
General disorders Femur fracture	6.1% 2/33 • Number of events 6 • 50 months
Gastrointestinal disorders Nausea	3.0% 1/33 • Number of events 6 • 50 months
Cardiac disorders Congestive heart failure	6.1% 2/33 • Number of events 6 • 50 months
Infections and infestations -sepsis	12.1% 4/33 • Number of events 6 • 50 months
Cardiac disorders BCPO-Heart failure	3.0% 1/33 • Number of events 6 • 50 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	9.1% 3/33 • Number of events 6 • 50 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non small cell lung cancer	9.1% 3/33 • Number of events 6 • 50 months
Musculoskeletal and connective tissue disorders Lumbar pain, vertebral collapse	3.0% 1/33 • Number of events 6 • 50 months
Cardiac disorders Atrial fibrillation	3.0% 1/33 • Number of events 6 • 50 months

Other adverse events

Other adverse events
Measure	Single Arm n=33 participants at risk 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.
Blood and lymphatic system disorders Anemia	18.2% 6/33 • Number of events 30 • 50 months
Blood and lymphatic system disorders Leukopenia	12.1% 4/33 • Number of events 30 • 50 months
Blood and lymphatic system disorders Neutropenia	45.5% 15/33 • Number of events 30 • 50 months
Blood and lymphatic system disorders Thrombocytopenia	33.3% 11/33 • Number of events 30 • 50 months
Cardiac disorders Cardiac disorders	15.2% 5/33 • Number of events 30 • 50 months
Gastrointestinal disorders Gastrointestinal disorders	36.4% 12/33 • Number of events 30 • 50 months
General disorders General disorders	18.2% 6/33 • Number of events 30 • 50 months
Hepatobiliary disorders Hepatobiliary disorders	6.1% 2/33 • Number of events 30 • 50 months
Infections and infestations Infections	21.2% 7/33 • Number of events 30 • 50 months
Injury, poisoning and procedural complications Injury	6.1% 2/33 • Number of events 30 • 50 months
Investigations Investigations	9.1% 3/33 • Number of events 30 • 50 months
Metabolism and nutrition disorders Metabolism	24.2% 8/33 • Number of events 30 • 50 months
Musculoskeletal and connective tissue disorders Musculoskeletal	24.2% 8/33 • Number of events 30 • 50 months
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm	6.1% 2/33 • Number of events 30 • 50 months
Nervous system disorders Nervous system	21.2% 7/33 • Number of events 30 • 50 months
Renal and urinary disorders Renal	6.1% 2/33 • Number of events 30 • 50 months
Respiratory, thoracic and mediastinal disorders Respiratory	15.2% 5/33 • Number of events 30 • 50 months
Vascular disorders Vascular	3.0% 1/33 • Number of events 30 • 50 months
General disorders Other	24.2% 8/33 • Number of events 30 • 50 months

Additional Information

Dr. Luigi Marcheselli - FIL statistician

Fondazione Italiana Linfomi ONLUS

Phone: 059 4223873

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER