ORCHARRD - Ofatumumab in Diffuse Large B-Cell NHL
Trial overview
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
Inclusion criteria
- Patients with relapsed DLBCL and ineligible for stem cell transplantation or relapsed DLBCL after autologous stem cell transplantation
- Tumor verified to be CD20+ from excisional or incisional lymph node biopsy
- CT scan in screening phase (based on local evaluation) showing:- 2 or more clearly demarcated lesions with a largest diameter greater or equal to 1.5cm, or 1 clearly demarcated lesion with a largest diameter greater or equal to 2cm
- ECOG performance status of 0,1, or 2
- Age 18 years or over
- Following receipt of verbal and written information about the trial, the patient must provide signed informed consent before any trial related activity is carried out
Exclusion criteria
- More than 1 previous radioimmunotherapy regimen
- Received radioimmunotherapy within 3 months prior to visit2
- Received any of the following treatments within 4 weeks prior to visit 2 - anti-cancer therapy, glucocorticoid unless given in doses equivelent to 10mg (equal or less) of prednisolone a day
- Received monoclonal antibodies, other than riuximab, within 3 months prior to visit 2
- Patients previously treated with other ant i- CD20 monoclonal antibodies than riuximab, tositumomab tiuxetan (the latter two in accordance with exclusion criteria No1 and 2
- Patients with previously diagnosed and teated indolent lymphoma
- Know CNS involvement of DLBCL
- Past or current malignancy, except for - cervical carcinoma stage 1B or less, Non-invasive basal cell and/or squamous cell carcinoma, malignant melenoma with a complete response of a duration of less than 10 years, other cancer diagnosis with a complete response of a duration of less than 5 years
- Chronic or ongoing active infectious disease including requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis and active hepatitis C.
- Clinically significant cardiac disease including unstable angina, acute myocardial infarction with six months from visit 1, congestive heart failure (NYHA III-IV), and arrhythmia requiring therapy, with the exception of extra systoles or minor conduction abnormalities.
- Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
- History of significant cerebrovascular disease
- Known HIV positive
- Positive serology for hepatitis B (HB) defined as: Positive test for HBsAg and/or Positive test for anti-HBs and anti-HBc. Patients with documented vaccination against Hepatitis B (primary and secondary immunization and booster) will not be considered positive.
- Screening lab values: Platelets < 50 x 10/9/L (unless due to DLBCL involvement of the bone marrow). Neutrophils < 1.0 x 10/9/L (unless due to DLBCL involvement of the bone marrow). Creatinine > 2.0 times upper normal limit (unless normal creatinine clearance). Total bilirubin > 1.5 times upper normal limit (unless due to liver involvement of DLBCL). ALT > 2.5 times upper normal limit (unless due to liver involvement of DLBCL). Alk Phos > 2.5 times upper normal limit (unless due to liver involvement of DLBCL).
- Known or suspected hypersensitivity to components of investigational product
- Life expectancy less than 6 months
- Patients who have received tratment wiht any non-marketed drug substance or experimental therapy within 4 weeks prior to visit 2
- Currents participation in any other interventional clinical trial
- Patients known or suspected of not being able to comply with a trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder)
- Breat feedinig women or women with a positive pregnacy test at visit 1
- Women of cheldbearing potential not willing to use adequate contraception during trial oand one year after last dose of ofatumumab. Adequate contraception is defined as hormonal birth control or intrauterine device. For patients in the USA the use of a double barrier method is also considered adequate.
Contact details
Other trials currently active for Diffuse Large B-Cell Lymphoma
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.
Tags
disease lymphoma monoclonal haematology human monoclonal human cd20 b-cell malignancies open-label cd20-positive