R-Codox-M/IVAC

Trial overview

A Phase II Single Arm Study of the use of
CODOX-M/IVAC with Rituximab (RCODOX-M/IVAC) in the treatment of
patients with Diffuse Large B-Cell
Lymphoma (International Prognostic
Index High or High-Intermediate Risk)

Inclusion criteria

a) Age 18-60 years (clinician to consider individual patients’ ability to tolerate
intensive chemotherapy).
b) Histologically proven diffuse large B cell non-Hodgkin’s lymphoma (DLBCL)
including all morphological variants, according to the current World Health
Organisation classification1. The B cell nature of the proliferation must be
verified by the positivity with an anti-CD20 antibody. All histology will be
reviewed by a central Lymphoma Trials Office pathology panel.
c) IPI score high-intermediate (score=3) or high (score=4,5). IPI defined as
stage III or IV, raised LDH and poor performance status – WHO performance
status >/= 2. (See Appendix 1).
d) No previous chemotherapy, radiotherapy or other investigational drug for
this indication.
e) Adequate bone marrow function with platelets > 100x109/l; neutrophils >
1.5x109/l at the time of study entry unless attributed to bone marrow
infiltration by lymphoma.
f) Serum creatinine < 150µmol/l, serum bilirubin < 35µmol/l and
transaminases < 2.5× upper limit of institutional normal range unless
attributed to lymphoma.
g) Normal MUGA or echocardiogram without areas of abnormal contractility
and left ventricular ejection fraction (LVEF) =50%. (only applicable if past
history of diabetes, cardiac disease or hypertension or abnormal resting ECG).
h) No concurrent uncontrolled medical condition.
i) No active malignant disease other than basal or squamous cell carcinoma of
the skin or carcinoma in situ of the uterine cervix in the last 10 years.
j) Life expectancy > 3 months.
k) Adequate contraceptive precautions for all patients of childbearing potential
l) Written, informed consent.

Exclusion criteria

a) T-cell lymphoma.
b) Previous history of treated or non-treated indolent lymphoma. However,
patients not previously diagnosed who have large B-cell lymphoma with some
small cell infiltration in bone marrow or lymph node may be included.
c) Past history of heart failure or uncontrolled angina pectoris.
d) Cardiac contra-indication to doxorubicin (abnormal contractility on
echocardiography or nuclear medicine examination [MUGA]).
e) Neurological contra-indication to vincristine (e.g. pre-existing diabetic
neuropathy).
f) Any other serious active disease.
g) General status that does not allow the administration of 2 cycles of
CODOX-M/IVAC according to the investigator.
h) Positive serology for HIV, Hepatitis B or Hepatitis C

Contact details

Research Nurse

Amy Codrington

Tel 0113 2068577

Email amy.codrington@leedsth.nhs.uk

Principal Investigator

Dr Rod Johnson

Tel 0113 2068369

Email rod.johnson@leedsth.nhs.uk

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