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New hope for lymphoma patients who Can't handle standard chemo

NCT ID NCT01679119

Disease control Sponsor: University College, London Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two different drug combinations for people with a type of blood cancer called diffuse large B-cell lymphoma (DLBCL) who cannot take the usual strong chemotherapy. The trial compared a newer drug (inotuzumab ozogamicin) plus standard therapy against another common combination. The goal was to see which works better and is safer for these patients, with 129 participants taking part.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

129 people

The number who actually took part.

Started

Oct 2013

Finished

Mar 2022

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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 \<10%. Patients previously treated should be free of sequelae of treatment which would compromise the delivery of study drugs as compared with other eligible patients. * No previous chemotherapy, radiotherapy or other investigational drug for this indication - previous corticosteroids up to a dose equivalent to prednisolone 1mg/kg/day for up to 14 days are permitted prior to randomisation EITHER * Unsuitable for anthracycline-containing chemotherapy due to impaired cardiac function defined by an ejection fraction of ≤ 50% OR Left ventricle ejection fraction \> 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) \< 30ml/min. GFR calculated by Cockroft-Gault (not eGFR). * Serological evidence of active hepatitis B or C infection whether acute or chronic (defined as positive anti-HCV serology; positive HBsAg). All positive HBcAb results should also be excluded on safety grounds regardless of HBsAg or HBV DNA status. Antibodies to Hepatitis B surface antigen (anti-HBs) due to a history of past vaccination is acceptable * Known history of HIV seropositive status * Patients with a history of Venoocclusive Disease (VOD) and Sinusoidal Obstructive Syndrome (SOS) * Patients with a screening of QTcF interval \>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

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma

Contacts and locations

Locations

  • Aintree University Hospital

    Liverpool, United Kingdom

  • Beatson West of Scotland Cancer Centre (including Gartnavel Royal Hospital)

    Glasgow, United Kingdom

  • Bristol Oncology Centre

    Bristol, United Kingdom

  • Castle Hill Hospital

    Cottingham, United Kingdom

  • Christie Hospital

    Manchester, United Kingdom

  • Churchill Hospital

    Oxford, United Kingdom

  • Darent Valley Hospital

    Dartford, United Kingdom

  • Derriford Hospital

    Plymouth, United Kingdom

  • Freeman Hospital

    Newcastle, United Kingdom

  • Guy's Hospital (including St Thomas's Hospital)

    London, United Kingdom

  • James Paget University Hospital

    Great Yarmouth, United Kingdom

  • Kent and Canterbury Hospital

    Canterbury, United Kingdom

  • Kettering General Hospital

    Kettering, United Kingdom

  • Kings Mill Hospital

    Sutton in Ashfield, United Kingdom

  • Leicester Royal Infirmary

    Leicester, United Kingdom

  • Luton and Dunstable Hospital

    Luton, United Kingdom

  • Medway Maritime Hospital

    Gillingham, United Kingdom

  • Norfolk and Norwich University Hospital

    Norwich, United Kingdom

  • North Hampshire Hospital

    Basingstoke, United Kingdom

  • North Tyneside Hosptial (including Wansbeck Hospital and Hexham General Hospital)

    North Shields, United Kingdom

  • Northwick Park Hospital

    Harrow, United Kingdom

  • Nottingham City Hospital

    Nottingham, United Kingdom

  • Princess Royal University Hospital

    Orpington, United Kingdom

  • Queen's Hospital

    Romford, United Kingdom

  • Royal Bournemouth Hospital

    Bournemouth, United Kingdom

  • Royal Cornwall Hospital

    Truro, United Kingdom

  • Royal Devon & Exeter Hospital

    Exeter, United Kingdom

  • Royal Free Hospital

    London, United Kingdom

  • Royal Hampshire County Hospital

    Winchester, United Kingdom

  • Royal Liverpool University Hospital

    Liverpool, United Kingdom

  • Royal United Hospital

    Bath, United Kingdom

  • Southampton General Hospital

    Southampton, United Kingdom

  • St James's University Hospital

    Leeds, United Kingdom

  • Stoke Mandeville Hospital (including Wycombe Hospital)

    Aylesbury, United Kingdom

  • Torbay Hospital

    Torquay, United Kingdom

  • University College London Hospital

    London, United Kingdom

  • University Hospital, Coventry

    Coventry, United Kingdom

  • West Suffolk Hospital

    Bury St Edmunds, United Kingdom

  • Worcester Royal Hospital (including Kidderminster Hospital and Alexandra Hospital)

    Worcester, United Kingdom

  • Wythenshawe Hospital (including Trafford General Hospital)

    Wythenshawe, United Kingdom

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Other studies related to the condition(s) this trial covers.