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
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)
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.