EUCTR2009-009256-20-IEActive, not recruitingNot Applicable
Ofatumumab versus Rituximab Salvage Chemoimmunotherapy followed by ASCT in Relapsed or Refractory DLBC
GlaxoSmithKline Research and Development Limited0 sites380 target enrollmentStarted: September 10, 2009Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 380
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •Subjects eligible for enrolment in the study must meet all of the following criteria:
- •1. CD20 positive DLBCL. Biopsies performed after termination of first-line treatment must confirm CD20 positive DLBCL.
- •2. Refractory to, or relapsed following, first-line treatment with rituximab combined with anthracycline-based chemotherapy. Relapse is defined as biopsy confirmed CD20 positive DLBCL after a complete response.
- •Refractory disease must fulfill one of the following:
- •partial response (PR) after termination of first-line treatment. Subjects must have received at least 6 cycles of rituximab combined with anthracycline-based chemotherapy. Subjects with stage I/II disease will also be eligible if treated with at least 3 cycles of rituximab combined with anthracycline-based chemotherapy and definitive involved-field radiation therapy. Biopsy confirmation of CD20 positive DLBCL is required.
- •stable disease (SD) after termination of first-line treatment. Subjects must have received at least 3 cycles of rituximab combined with anthracycline-based chemotherapy. Biopsy confirmation of CD20 positive DLBCL is preferred but not required.
- •progressive disease (PD). Biopsy confirmation of CD20 positive DLBCL is preferred but not required.
- •Disease response to first-line treatment should be determined according to Revised Response Criteria for Malignant Lymphoma [Cheson, 2007], or if PET scanning was not used, International Workshop Response criteria for NHL [Cheson, 1999].
- •3. Baseline FDG-PET scans must demonstrate positive lesions compatible with CT defined anatomical tumor
- •4. CT scan showing at least:
- •2 or more clearly demarcated lesions/nodes with a largest diameter =1.5 cm and not previously irradiated
- •1 clearly demarcated lesion/node with a largest diameter =2.0 cm and not previously irradiated.
- •5. Age =18
- •6. ECOG performance status 0, 1, or 2.
- •7. Eligible for high dose chemotherapy and ASCT.
- •8. Resolution of toxicities from first-line therapy to grade=1.
- •9. Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1. Any previous cancer therapy for DLBCL, with the exception of:
- •First-line treatment with rituximab in combination with an anthracycline-based chemotherapy.
- •Radiotherapy as part of the first-line treatment plan or to a limited field at a maximum dose of =10Gy to control
- •life-threatening symptoms.
- •2. Received any of the following treatments within 4 weeks prior to start of study therapy (unless otherwise
- •Anti-cancer therapy (e.g. alkylating agents, anti-metabolites, purine analogues)
- •Radiotherapy unless it is to a limited field at a maximum dose of =10Gy to control life-threatening symptoms.
- •3. Treatment with any known non-marketed drug substance or experimental therapy within 5 terminal half lives or 4 weeks prior to enrollment, whichever is longer, or currently participating in any other interventional clinical study
- •4. Glucocorticoid use, unless given in doses =100mg/day hydrocortisone (or equivalent dose of other glucocorticoid-refer to the SPM for glucocorticoid equivalent doses) for <7 days for exacerbations other than lymphoma (e.g. asthma)
- •5. History of significant cerebrovascular disease or event with significant symptoms or sequelae.
- •6. Clinically significant cardiac disease including unstable angina, acute myocardial infarction within six months prior to randomisation, congestive heart failure (NYHA III-IV), and arrhythmia unless controlled by therapy, with the exception of extra systoles or minor conduction abnormalities.
- •7. Significant concurrent, uncontrolled medical condition including, but not limited to, renal, hepatic, gastrointestinal, endocrine, pulmonary, neurological, cerebral or psychiatric disease.
- •8. Known DLBCL involvement of the CNS.
- •9. Known or suspected hypersensitivity to study treatments that, in the opinion of the investigator or GSKmedical Monitor, contraindicates their participation
- •10. Known HIV positivity.
- •11. Positive serology for hepatitis B (HB) defined as a positive test for HBsAg. In addition, if negative for HBsAg but HBcAb positive and HBsAb negative, a HB DNA test will be performed and if positive the subject will be excluded. Note: If HBcAb positive and HBsAb positive, which is indicative of a past infection, the
- •subject can be included.
- •12. Positive serology for hepatitis C (HC) defined as a positive test for HCAb, in which case reflexively perform a HC RIBA immunoblot assay on the same sample to confirm the result.
- •13. Chronic or current infectious disease requiring systemic antibiotics, antifungal, or antiviral treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis and tuberculosis.
- •14. Other past or current malignancy. However, subjects who have been free of malignancy for at least 5 years, or have a history of completely resected non melanoma skin cancer, or successfully treated in situ carcinoma are eligible.
- •15. Prior treatment with anti-CD20 monoclonal antibodies with the exception of rituximab or treated with other monoclonal antibodies within 3 months prior to start of study therapy.
- •16. Screening laboratory 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 DLBC
Investigators
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