Trial Outcomes & Findings for Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy (NCT NCT01679119)

Last Updated: 2026-04-07

Results Overview

Progression free survival rate and will be analysed using Kaplan-Meier survival analysis. PFS time will be measured from date of randomisation until progression or death.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

129 participants

Primary outcome timeframe

At 2 years following date of randomisation.

Results posted on

2026-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	IO-R-CVP Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). Cyclophosphamide: Cyclophosphamide 750mg/m2 IV, given day 1 Vincristine: Vincristine 1.4mg/m2(max 2mg)IV given day 1 Prednisolone: Prednisolone 100mg OD Oral given days 1-5 Rituximab: Rituximab 375mg/m2 IV given day 1 Inotuzumab Ozogamicin: Inotuzumab Ozogamicin 0.8mg/m2 IV given on day 2	Gem-R-CVP Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone). Cyclophosphamide: Cyclophosphamide 750mg/m2 IV, given day 1 Vincristine: Vincristine 1.4mg/m2(max 2mg)IV given day 1 Prednisolone: Prednisolone 100mg OD Oral given days 1-5 Rituximab: Rituximab 375mg/m2 IV given day 1 Gemcitabine: Gemcitabine up to 1g/m2 IV given day 1 and day 8 (Patients with ECOG PS 0-1: starting dose: 875mg/m2 (1st cycle). If tolerated can be escalated to 1g/m2 in cycle 2 and subsequent cycles. Patients with ECOG PS 2: starting dose 750mg/m2 (1st cycle). If tolerated can be escalated to 875mg/m2 in cycle 2 and then escalated to 1g/m2 in cycle 3 and subsequent cycles.)
Overall Study STARTED	65	64
Overall Study COMPLETED	60	63
Overall Study NOT COMPLETED	5	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IO-R-CVP n=60 Participants Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). Cyclophosphamide: Cyclophosphamide 750mg/m2 IV, given day 1 Vincristine: Vincristine 1.4mg/m2(max 2mg)IV given day 1 Prednisolone: Prednisolone 100mg OD Oral given days 1-5 Rituximab: Rituximab 375mg/m2 IV given day 1 Inotuzumab Ozogamicin: Inotuzumab Ozogamicin 0.8mg/m2 IV given on day 2	Gem-R-CVP n=63 Participants Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone). Cyclophosphamide: Cyclophosphamide 750mg/m2 IV, given day 1 Vincristine: Vincristine 1.4mg/m2(max 2mg)IV given day 1 Prednisolone: Prednisolone 100mg OD Oral given days 1-5 Rituximab: Rituximab 375mg/m2 IV given day 1 Gemcitabine: Gemcitabine up to 1g/m2 IV given day 1 and day 8 (Patients with ECOG PS 0-1: starting dose: 875mg/m2 (1st cycle). If tolerated can be escalated to 1g/m2 in cycle 2 and subsequent cycles. Patients with ECOG PS 2: starting dose 750mg/m2 (1st cycle). If tolerated can be escalated to 875mg/m2 in cycle 2 and then escalated to 1g/m2 in cycle 3 and subsequent cycles.)	Total n=123 Participants Total of all reporting groups
Age, Continuous	79 Years n=60 Participants	78 Years n=63 Participants	79 Years n=123 Participants
Sex: Female, Male Female	21 Participants n=60 Participants	20 Participants n=63 Participants	41 Participants n=123 Participants
Sex: Female, Male Male	39 Participants n=60 Participants	43 Participants n=63 Participants	82 Participants n=123 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: At 2 years following date of randomisation.

Progression free survival rate and will be analysed using Kaplan-Meier survival analysis. PFS time will be measured from date of randomisation until progression or death.

Outcome measures

Outcome measures
Measure	IO-R-CVP n=60 Participants Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). Cyclophosphamide: Cyclophosphamide 750mg/m2 IV, given day 1 Vincristine: Vincristine 1.4mg/m2(max 2mg)IV given day 1 Prednisolone: Prednisolone 100mg OD Oral given days 1-5 Rituximab: Rituximab 375mg/m2 IV given day 1 Inotuzumab Ozogamicin: Inotuzumab Ozogamicin 0.8mg/m2 IV given on day 2	Gem-R-CVP n=63 Participants Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone). Cyclophosphamide: Cyclophosphamide 750mg/m2 IV, given day 1 Vincristine: Vincristine 1.4mg/m2(max 2mg)IV given day 1 Prednisolone: Prednisolone 100mg OD Oral given days 1-5 Rituximab: Rituximab 375mg/m2 IV given day 1 Gemcitabine: Gemcitabine up to 1g/m2 IV given day 1 and day 8 (Patients with ECOG PS 0-1: starting dose: 875mg/m2 (1st cycle). If tolerated can be escalated to 1g/m2 in cycle 2 and subsequent cycles. Patients with ECOG PS 2: starting dose 750mg/m2 (1st cycle). If tolerated can be escalated to 875mg/m2 in cycle 2 and then escalated to 1g/m2 in cycle 3 and subsequent cycles.)
Progression Free Survival	49.2 percentage Interval 35.9 to 61.1	46.9 percentage Interval 33.9 to 58.8

SECONDARY outcome

Timeframe: Approximately 6 months after treatment start

At the end of treatment

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 5 years from date of registration

Date of registration until death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 7 months from beginning of treatment

During treatment and follow up visits

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, during treatment and 6 month and 2 year follow up

QoL questionnaires (EORTC QLQ-C30; Quality of life of cancer patients; 30 questions) to be completed by patient at time points listed below

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, during treatment and 6 month and 2 year follow up

Activities of Daily Living questionnaire (ADL) to be completed by patient at time points listed below (6 questions about ability to undertake self-care)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, during treatment and 6 month and 2 year follow up

Instrumental Activities of Daily Living questionnaire (IADL) to be completed by patient at time points listed below (8 questions about ability to undertake daily activities/self-care)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline, every 21 days for 8 cycles, 5 1/2 months at the end of treatment and then up to 3 years after the end of treatment.

Performance status to be measured by investigator at time points listed below

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline

Details of co-morbidities to be recorded at point of randomisation by investigator

Outcome measures

Outcome data not reported

Adverse Events

IO-R-CVP

Serious events: 35 serious events

Other events: 56 other events

Deaths: 9 deaths

Gem-R-CVP

Serious events: 44 serious events

Other events: 58 other events

Deaths: 9 deaths

Serious adverse events

Other adverse events

Additional Information

INCA Trial Manager

University College London

Phone: 02076799860

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	IO-R-CVP n=63 participants at risk Inotuzumab Ozogamicin plus Rituximab and CVP (Cyclophosphamide, vincristine \& prednisolone). Cyclophosphamide: Cyclophosphamide 750mg/m2 IV, given day 1 Vincristine: Vincristine 1.4mg/m2(max 2mg)IV given day 1 Prednisolone: Prednisolone 100mg OD Oral given days 1-5 Rituximab: Rituximab 375mg/m2 IV given day 1 Inotuzumab Ozogamicin: Inotuzumab Ozogamicin 0.8mg/m2 IV given on day 2	Gem-R-CVP n=63 participants at risk Gemcitabine plus Rituximab and CVP (Cyclophosphamide, Vincristine and Prednisolone). Cyclophosphamide: Cyclophosphamide 750mg/m2 IV, given day 1 Vincristine: Vincristine 1.4mg/m2(max 2mg)IV given day 1 Prednisolone: Prednisolone 100mg OD Oral given days 1-5 Rituximab: Rituximab 375mg/m2 IV given day 1 Gemcitabine: Gemcitabine up to 1g/m2 IV given day 1 and day 8 (Patients with ECOG PS 0-1: starting dose: 875mg/m2 (1st cycle). If tolerated can be escalated to 1g/m2 in cycle 2 and subsequent cycles. Patients with ECOG PS 2: starting dose 750mg/m2 (1st cycle). If tolerated can be escalated to 875mg/m2 in cycle 2 and then escalated to 1g/m2 in cycle 3 and subsequent cycles.)
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorder	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Vascular disorders Hypotension	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	9.5% 6/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Gastrointestinal disorders Abdominal pain	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Gastrointestinal disorders Diarrhoea	6.3% 4/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
General disorders Fatigue	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	11.1% 7/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Infections and infestations Lung infection	11.1% 7/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	20.6% 13/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Infections and infestations Other: Infection of unknown origin	11.1% 7/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	6.3% 4/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Infections and infestations Sepsis	4.8% 3/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	6.3% 4/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Injury, poisoning and procedural complications Fall	9.5% 6/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Alanine aminotransferase increased	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	17.5% 11/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Alkaline phosphatase increased	4.8% 3/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Aspartate aminotransferase increased	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Blood bilirubin increased	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Cardiac troponin T increased	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Creatinine increased	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Electrocardiogram QT corrected interval prolonged	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations GGT increased	6.3% 4/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Lymphocyte count decreased	42.9% 27/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	60.3% 38/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Neutrophil count decreased	23.8% 15/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	41.3% 26/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations Platelet count decreased	27.0% 17/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	28.6% 18/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Investigations White blood cell decreased	12.7% 8/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	44.4% 28/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Metabolism and nutrition disorders Hypnoatremia	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	6.3% 4/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Musculoskeletal and connective tissue disorders Musculoskeletal and connective tissue disorders	4.8% 3/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms benign, malignant and unspecified (incl cysts and polyps)	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Nervous system disorders Nervous system disorders	11.1% 7/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Product Issues Other (non CTCAE)	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Psychiatric disorders Confusion	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Renal and urinary disorders Renal and urinary disorders	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	4.8% 3/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	15.9% 10/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Blood and lymphatic system disorders Anaemia	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	25.4% 16/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Blood and lymphatic system disorders Febrile Neutropenia	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	17.5% 11/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Cardiac disorders Cardiac Arrest	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	4.8% 3/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Cardiac disorders Chest pain - cardiac	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	4.8% 3/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Cardiac disorders Heart Failure	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Cardiac disorders Myocardial infarction	3.2% 2/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	7.9% 5/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Cardiac disorders Pericarditis	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Cardiac disorders Ventricular tachycardia	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)
Eye disorders Eye disorder	1.6% 1/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)	0.00% 0/63 • Between informed consent and the end of trial (when all patients have completed at least two years of follow up post treatment)