A trial testing a new agent for patients with diffuse large B cell lymphoma (DLBCL) who have heart conditions and unable to receive standard treatment
- Conditions
- Diffuse large B cell lymphomaMedDRA version: 21.0 Level: PT Classification code 10012818 Term: Diffuse large B-cell lymphoma System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2012-001900-39-GB
- Lead Sponsor
- niversity College London
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Not specified
- Target Recruitment
- 132
Inclusion criteria for randomisation:-
a. Informed written consent for the trial
b. 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.
c. Bulky Stage IA (lymph node or lymph node mass =10cm in maximum diameter), stage IB, stage II, stage III and stage IV disease
d. ECOG performance status 0-2
e. Measurable disease
f. Age 18 = years
g. Adequate contraceptive precautions for all patients of childbearing potential
h.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. Cases with second malignancy where eligibility is uncertain should be discussed in the first instance with the CTC.
i. 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
j. 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
k. 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
l. Life expectancy >3 months
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 10
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 122
Exclusion criteria for randomisation:-
a. Symptomatic central nervous system or meningeal involvement by DLBCL
b. Previous diagnosis of low grade lymphoma which has been treated with a systemic therapy
c. Non-bulky stage IA disease
d. ECOG performance status 3-4
e. History of chronic liver disease or suspected alcohol abuse
f. Serum bilirubin greater than upper limit of normal unless attributable to Gilberts syndrome or haemolysis
g. Alanine and/or aspartate aminotransferase levels (ALT and/or AST) and alkaline phosphatase (ALP) greater than 2.5 times the upper limit of normal
h. Glomerular filtration rate (GFR) <30ml/min. GFR calculated by Cockroft-Gault (not eGFR).
i. 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
j. Known history of HIV seropositive status
k. Medical or psychiatric conditions compromising the patient’s ability to give informed consent
l. Women who are pregnant or lactating
m. LVEF >50% in the absence of significant co-morbidities that preclude anthracycline use
n. Patients with a history of severe allergic/anaphylactic reaction to any humanised monoclonal antibody
o. Patients with serious active infection
p. Patients with a history of Venoocclusive Disease (VOD) and Sinusoidal Obstructive Syndrome (SOS)
q. Patients with a screening of QTcF interval >470msec
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method