Phase 2
N=129
Treatment of Patients With Diffuse Large B Cell Lymphoma Who Are Not Suitable for Anthracycline Containing Chemotherapy
Diffuse Large B Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT01679119 ↗Enrolled (actual)
129
Serious AEs
62.7%
Results posted
Mar 2026
Primary outcome: Primary: Progression Free Survival — 49.2; 46.9 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cyclophosphamide (Drug); Vincristine (Drug); Prednisolone (Drug); Rituximab (Drug); Inotuzumab Ozogamicin (Drug); Gemcitabine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University College, London
- Primary completion
- Mar 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression Free Survival |
49.2; 46.9 | — |
| SECONDARY Overall Response Rate |
— | — |
| SECONDARY Overall Survival |
— | — |
| SECONDARY Treatment Toxicity |
— | — |
| SECONDARY Quality of Life of Patients During and After Treatment |
— | — |
| SECONDARY Activities of Daily Living of Patients During and After Treatment |
— | — |
| SECONDARY Instrumental Activities of Daily Living of Patients During and After Treatment |
— | — |
| SECONDARY Performance Status Post Treatment |
— | — |
| SECONDARY Co-morbidities of Patients |
— | — |
Summary
The purpose of this trial is to compare the efficacy and safety of Inotuzumab Ozogamicin in combination with R-CVP with that of R-G-CVP for the treatment of Diffuse Large B Cell Lymphoma (DLBCL) in a population of patients not suitable for anthracycline based chemotherapy.
There is no standard of care for the treatment of this group of patients. If demonstrated to be efficacious and safe to deliver this regimen will be further tested in a phase III trial to determine whether this should become the standard of care amongst patients with DLBCL not fit for anthracycline (R-CHOP).
Eligibility Criteria
Inclusion criteria
- Informed written consent for the trial
- Histologically proven diffuse large B cell lymphoma (DLBCL) according to the current World Health Organisation (WHO) classification including all morphological variants. The B cell nature of the proliferation must be verified by demonstration of CD20 positivity. A concurrent (synchronous) diagnosis of low grade lymphoma (e.g. on bone marrow trephine or presence of both low grade and DLBCL in a lymph node biopsy) or previous diagnosis of low grade lymphoma which hasn't been treated with a systemic therapy is permitted
- Bulky Stage IA (lymph node or lymph node mass ≥ 10cm in maximum diameter), stage IB, stage II, stage III and stage IV disease
- ECOG performance status 0-2
- Measurable disease
- Age 18 ≥ years
- Adequate contraceptive precautions for all patients of childbearing potential
- History of malignant disease diagnosed at any time in the past with completed radical treatment and the risk of relapsing within the next 5 years is 50% but in the presence of significant co-morbidities (diabetes mellitus, hypertension or ischaemic heart disease) precluding anthracycline-containing chemotherapy as determined by treating physician. Co-morbidities must be documented on the randomisation form and CIRS score recorded
- Adequate bone marrow function (Platelets > 100x109/l, WBC > 3.0x109/l, Neutrophils > 1.5x109/l) at time of study entry unless attributed to bone marrow infiltration by DLBCL
- Life expectancy > 3 months
Exclusion criteria
- Symptomatic central nervous system or meningeal involvement by DLBCL
- Previous diagnosis of low grade lymphoma which has been treated with a systemic therapy
- Non-bulky stage IA disease
- ECOG performance status 3-4
- History of chronic liver disease or suspected alcohol abuse
- Serum bilirubin greater than upper limit of normal unless attributable to Gilberts syndrome or haemolysis
- Alanine and/or aspartate aminotransferase levels (ALT and/or AST) and alkaline phosphatase (ALP) greater than 2.5 times the upper limit of normal
- Glomerular filtration rate (GFR) 470msec
- Medical or psychiatric conditions compromising the patient's ability to give informed consent
- Women who are pregnant or lactating
- LVEF > 50% in the absence of significant co-morbidities that preclude anthracycline use
- Patients with a history of severe allergic/anaphylactic reaction to any humanised monoclonal antibody
- Patients with serious active infection
Data sourced from ClinicalTrials.gov (NCT01679119). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.