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
Other trials currently active for Diffuse Large B-Cell Lymphoma
ORCHARRD - Ofatumumab in Diffuse Large B-Cell NHL
An open-label, single-arm multi-center phase 2 trial with ofatumumab in patinets with relapsed Diffuse Large B-Cell Lymphoma (DLBCL) ineligible for transplant or relapsed after autologous transplant
The Celgene DLC-001 study is for patients whose Diffuse Large B-cell Lymphoma (DLBCL) does not respond to (refractory) or comes back after chemotherapy treatment (relapsed).
Lymphoma is a cancer of a type of blood cell called lymphocytes. DLBCL is just one type of lymphoma. The main purpose of this study is to see if an experimental drug called lenalidomide is better than any one of four other drugs at fighting this type of cancer.
The second purpose of this study is to see if lenalidomide is better than any one of the four drugs at fighting a particular subtype of cancer. There are two types of DLBCL called GCB and non-GCB subtypes. Scientists can look at cells and genes in the laboratory and see that the two kinds are different, but they don’t know yet what the difference means. To patients and to doctors, these two kinds seem the same. Right now, doctors don’t usually do tests to find out which kind a patient has because the treatment is the same for both.
There is also currently no approved drug for relapsed/refractory DLBCL. There are, however, some drugs that are approved for other cancers that doctors often use for this type of cancer. These other drugs are a “practical” standard of care but not an approved standard of care by health authorities. Some of these drugs were chosen for this study to compare against lenalidomide. They are gemcitabine, rituximab, etoposide and oxaliplatin.
Patients who are eligible to participate in the study would be randomly selected to receive either lenalidomide or your doctor’s choice of a practical standard of care.
If you are in the first group, you would keep taking lenalidomide as long as your DLBCL does not get worse. If you are in the second group, you would take the practical standard of care drug for its usual prescribed period, usually 6 cycles, as long as your DLBCL does not get worse.
If your DLBCL does get worse and you are taking a practical standard of care drug, your doctor may be able to give you the option to receive lenalidomide, if you are in good enough general health at the time.
Either way, the doctors and nurses will continue to follow up with you to monitor your general health.
Tags
disease lymphoma monoclonal haematology b-cell malignancies multicentre rituximab untreated mabthera cd20-positive newly diagnosed